LymphomaPhase 1NCT03530683
A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When Used in Combination With Other Medicines to Treat Participants With Advanced Hematological Malignancies, Including Lymphoma, Leukemia and Multiple Myeloma
A Phase 1 study testing Maplirpacept (PF-07901801), Azacitidine and Venetoclax in people with Lymphoma and Multiple Myeloma, run by Pfizer at 62 sites in United States.
Trial summary
The purpose of this clinical trial is to learn how the experimental medicine maplirpacept (PF-07901801) affects people with various types of blood cancers: relapsed or refractory (R/R) lymphoma multiple myeloma newly diagnosed acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia
- What is being tested?
- Maplirpacept (PF-07901801), Azacitidine and Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 62 sitesUnited States
- Study dates
- 14 May 2018to 18 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Key Inclusion Criteria (Phase 1a and Phase 1b, all Cohorts):
- Available fresh or archived tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Adequate coagulation function.
- Adequate hepatic function.
- Adequate hematologic status.
- Adequate renal function.
- Recovery from non-hematopoietic toxicities of previous anticancer drugs or radiotherapy or previous surgeries to ≤Grade 1 (or to baseline grade if condition was pre-existing).
Key Inclusion Criteria (Phase 1a): Histologically confirmed relapsed/refractory, transfusion- independent lymphoma (Hodgkin or non-Hodgkin) per the 2014 Lugano classification.
Key Inclusion Criteria (Phase 1b Cohort A1 and A2): Histologically confirmed, newly diagnosed TP53-mutated Acute Myeloid Leukemia (AML).
Key Inclusion Criteria (Phase 1b Cohort B1 and B2): Histologically confirmed, newly diagnosed TP53-wildtype AML, elderly or unfit for more aggressive treatment.
Key Inclusion Criteria (Phase 1b Cohorts C1, C2, C3 and E1, E2, F1, F2, F3): Histologically documented relapsed/refractory Multiple Myeloma (MM).
Key Inclusion Criteria (Phase 1b Cohort D1 and D2): Pathologically confirmed relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
Key Exclusion Criteria (Phase 1a and Phase 1b, all Cohorts):
- Known, current central nervous system disease involvement.
- Use of any investigational agent or any anticancer drug within 14 days before planned start of study treatment (within 4 weeks for antibody-based therapies and within 8 weeks for cell-based therapies).
- Subjects who have undergone radiation therapy within 14 days of study treatment administration.
- Hematopoietic stem cell transplant within 90 days before the planned start of study treatment or subjects with active graft-vs-host disease, with the exception of Grade 1 skin involvement.
- Major surgery within 30 days before planned start of study treatment.
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
United States62 sites
University of Michigan Hospitals
Ann Arbor, Michigan, 48109
University of Michigan
Ann Arbor, Michigan, 48109
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342
Northside Hospital
Atlanta, Georgia, 30342
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, 07920
Roswell Park Cancer Institute
Buffalo, New York, 14263
Gabrail Cancer Center Research
Canton, Ohio, 44718
Novant Health Cancer Institute - Research Office
Charlotte, North Carolina, 28204
Novant Health Cancer Institute Hematology - Charlotte
Charlotte, North Carolina, 28204
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, 11725
Colorado Blood Cancer Institute
Denver, Colorado, 80218
HealthONE Presbyterian/St. Luke's Medical Center
Denver, Colorado, 80218
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Summit Medical Group Cancer Center
Florham Park, New Jersey, 07932
Prisma Health, Institute for Translational Oncology Research, Clinical Research Unit
Greenville, South Carolina, 29605
Prisma Health-Upstate Cancer Institute
Greenville, South Carolina, 29605
Memorial Sloan Kettering Cancer Center at Westchester
Harrison, New York, 10604
Oncology Consultants P.A.
Houston, Texas, 77030
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana Blood & Marrow Transplantation
Indianapolis, Indiana, 46237
Indiana Blood and Marrow Transplantation-Administrative Offices
Indianapolis, Indiana, 46237
Indiana Blood and Marrow Transplantation-Clinic
Indianapolis, Indiana, 46237
University of TN Medical Center
Knoxville, Tennessee, 37920
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York, 11101
Keck Hospital of USC
Los Angeles, California, 90033
LAC+USC Medical Center
Los Angeles, California, 90033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Norton Cancer Institute, St Matthews Campus
Louisville, Kentucky, 40207
Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD
Louisville, Kentucky, 40207
Norton Diagnostic Center-Dupont (PET Scans)
Louisville, Kentucky, 40207
Norton Women & Children's Hospital
Louisville, Kentucky, 40207
Memorial Sloan Kettering Cancer Center at Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center at Montvale
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center - David H. Koch Center
New York, New York, 10021
Memorial Sloan Kettering Cancer Center (Outpatient Center)
New York, New York, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Christiana Care Health Services
Newark, Delaware, 19713
Christiana Care Hematology Oncology - Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center
Newark, Delaware, 19713
Christiana Care Health Services - Christiana Hospital
Newark, Delaware, 19718
Keck Hospital of USC Pasadena
Pasadena, California, 91105
Sidney Kimmel Cancer Center, Clinical Trials Organization
Philadelphia, Pennsylvania, 19107
Sidney Kimmel Cancer Center, Research Support Services
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University Investigational Drug Services
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University, Investigational Drug Service
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University, Medical Oncology
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Swedish Cancer Institute
Seattle, Washington, 98104
Swedish Medical Center
Seattle, Washington, 98122
Tampa General Hospital Cancer Institute
Tampa, Florida, 33606
Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Memorial Sloan Kettering Cancer Center at Nassau
Uniondale, New York, 11553
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Novant Health Cancer Institute - Research Office
Winston-Salem, North Carolina, 27103
Novant Health Cancer Institute Hematology - Forsyth
Winston-Salem, North Carolina, 27103
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 1a/1b Dose-Escalation and Expansion Trial of TTI-622 in Patients With Advanced Hematologic Malignancies, Including Lymphoma, Leukemia, and Multiple Myeloma
The purpose of this clinical trial is to learn how the experimental medicine maplirpacept (PF-07901801) affects people with various types of blood cancers:
- relapsed or refractory (R/R) lymphoma
- multiple myeloma
- newly diagnosed acute myeloid leukemia (AML).
Read more
This trial will be conducted in the outpatient setting in 2 parts, phase 1a and phase 1b. You may only participate in one part of the study.
During phase 1a of this study, we will explore how much maplirpacept (PF-07901801), when used by itself, can be safely used.
If you have lymphoma, the study medicine maplirpacept (PF-07901801) will be given by infusion through a vein once a week or once every 2 weeks or every 3 weeks as determined by your doctor. Following your first dose, you will be expected to come back twice more the first week. From week 2, you will have weekly visits for blood tests, questions about your medications, any side effects, or illnesses you may have experienced and your cancer response. After you have completed 21 days (for every week dosing) or 42 days (for every 2- or 3-weeks dosing), your doctor will discuss whether you should stop study treatment or continue.
If you continue, you will be expected to come back weekly for blood tests, vital signs, a brief physical exam, asked about any side effects or illnesses you may have experienced and medications you may be taking. The dosing schedule you are assigned to will continue until your disease has worsened, significant side effects occur or other reasons that lead you and your doctor to decide treatment may be stopped.
To be eligible for the first part of the study you must be 18 years or older, your disease has worsened after receiving other medicines approved for blood cancer, no other treatment options exist for you, a sample of your tissue for exploratory research which can be taken from tissue already obtained or if necessary, a new sample of your tissue will be taken so your disease may be seen and measured on routine tests/scans. If you have had radiation therapy or received any anticancer medication within 14 days before the planned start of study treatment your doctor will let you know if you are eligible to participate in the study. If you have had major surgery within 30 days before the planned start of study treatment you may not be eligible to participate.
The phase 1a part of the study may last up to 51/2 years. How long you participate in this study depends on side effects you may have to the study drug. It also depends on how your cancer responds to the study drug. Therefore, you may remain in the study as long as you and your study doctor think you may benefit. However, you are free to stop taking part in this study at any time and for any reason.
During phase 1b part of this study, we will explore how much maplirpacept (PF-07901801), when used with other anticancer medicine(s), can be safe and reduce cancer growth. In the phase 1b part of this study, you will receive maplirpacept (PF-07901801) and other anticancer medicine(s). Which medicine combination you will receive depends on the types of cancer under treatment. Your treatment experiences will be examined to determine if maplirpacept (PF-07901801) when given with other anticancer medicine(s), is safe and can reduce cancer growth.
To be eligible for the second part of the study you may have newly diagnosed Acute Myelocytic Leukemia with or without a genetic mutation or you have Multiple Myeloma or Diffuse Large B Cell Lymphoma, and your disease has worsened.
The Phase 1b part of this study may last as long as you and your study doctor think you may benefit which could be up to approximately 31/2 years. How long you participate in this study depends on side effects you may have to the study drug. It also depends on how your cancer responds to the study drug. Therefore, you may remain in the study as long as you and your study doctor think you may benefit. However, you are free to stop taking part in this study at any time and for any reason.
Read the detailed description
This is a trial of maplirpacept (PF-07901801) in subjects with relapsed or refractory lymphoma or multiple myeloma (MM) and subjects with newly diagnosed acute myeloid leukemia (AML).
This trial will be conducted in 2 phases: Phase 1a (Dose-Escalation Phase for Single-Agent maplirpacept (PF-07901801) and Phase 1b maplirpacept (PF-07901801) Combinations and Single-Agent.
In the Dose-Escalation Phase for Single-Agent maplirpacept (PF-07901801), subjects with relapsed or refractory lymphoma will be enrolled in sequential dose cohorts.
In the Combination and Single-Agent Treatment part, subjects will be included in 1 of 14 cohorts: (Cohort A1 and A2) subjects with newly diagnosed TP53-mutated AML will be treated with maplirpacept (PF-07901801) + azacitidine; (Cohort B1 and B2) elderly subjects or subjects unfit for intensive induction chemotherapies with newly diagnosed TP53-wildtype AML will be treated with maplirpacept (PF-07901801) + azacitidine and venetoclax; (Cohort C1, C2, and C3) subjects with relapsed or refractory MM will be treated with maplirpacept (PF-07901801) + carfilzomib and dexamethasone;(Cohort D1 and D2) subjects in relapsed or refractory CD20+ diffuse large B-cell lymphoma will be treated with maplirpacept (PF-07901801) + an anti-CD20 targeting agent; (Cohort E1 and E2) subjects with relapsed refractory MM will be treated with single-agent maplirpacept (PF-07901801); and (Cohorts F1, F2 and F3) with relapsing or refractory MM will be treated with increasing doses of maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone.
- Being tested
- Maplirpacept (PF-07901801), Azacitidine, Venetoclax, Carfilzomib, Dexamethasone
- Keywords
- Neoplasms, Lymphoma, Myeloma, Leukemia
- Medical subject headings
- Lymphoma, Multiple Myeloma, Leukemia, Myeloid, Acute, Lymphoma, Large B-Cell, Diffuse, Neoplasms, Neoplasms, Plasma Cell, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maplirpacept (PF-07901801)Drug
Also called SIRPα-IgG4 Fc, TTI-622
maplirpacept (PF-07901801) will be administered by intravenous infusion at ranging doses, as determined from sequential dosing cohorts.
AzacitidineDrug
Also called VIDAZA
intravenous (IV) or subcutaneous (SC) daily for 7 days, repeated every 4 weeks
VenetoclaxDrug
Also called VENCLEXTA
orally daily for each day of each cycle (first 7 doses taken in clinic). The ramp-up and target dose of venetoclax will be adjusted per the package insert in subjects who are taking concomitant moderate or strong CYP3A4 inhibitors or posaconazole
CarfilzomibDrug
Also called KYPROLIS
Days 1, 8, and 15 of 28-day cycles; starting dose IV given on Cycle (C) 1 Day (D) 1, and if tolerated, then increased dose via IV given starting on C1D8 and subsequent doses thereafter.
DexamethasoneDrug
starting dose via IV on Days 1, 8, 15, and increased dose via IV on 28-day cycles
Anti-CD20 Targeting agentDrug
Also called Ruxience or Rituxan
Days 1,8,15, and 22 of the first 28-day cycle and then on Day 1 of subsequent 21-day cycles. The anti-CD20 targeting agent will be administered for a total of eight doses, and then Cohort F1, F2 and F3: TTI-622 + isatuximab, carfilzomib and dexamethasone Cohort C1, C2 and C3: TTI-622 + Carfilzomib and Dexamethasone will be continued as single-agent therapy.
IsatuximabDrug
Also called Sarclisa
F1: IV dose C0D1, C0D8, C0D15 and C0D22 (lead in phase);weekly during Cycle 1; Cycle 2 and beyond will be administered on Days 1 and 15 (Q2W).
F2 and F3: IV dose C0D1 and C0D8 (lead in phase); C1D1, C1D8, C1D15 and C1D22; Cycle 2 and beyond will be administered on days 1 and 15 (Q2W). Carfilzomib: IV dose on days 1 and 2 of cycle 1; then increased IV dose on days 8, 9, 15, and 16 of cycle 1; cycle 2 and beyond: increased IV dose on days 1, 2, 8, 9, 15, and 16. Dexamethasone IV or PO on days 1, 2, 8, 9, 15, 16, 22, and 23 starting cycle 1.
| Study group | Role | What they receive |
|---|---|---|
| maplirpacept (PF-07901801) Monotherapy | Experimental | In the phase 1a dose- escalation part for single-agent maplirpacept (PF-07901801), participants with Relapsing or Refractory (R/R) lymphoma will be enrolled in sequential dose cohorts to receive maplirpacept (PF-07901801) QW to characterize safety, tolerability, and PK; to determine the Maximum Tolerated Dose (MTD) or P1b Starting Dose (a dose lower than or equal to the single-agent MTD), and to gain preliminary evidence of antitumor activity.
In addition, participants with R/R Lymphoma may also be enrolled in a cohort to receive maplirpacept (PF-07901801) Q2W and a cohort to receive maplirpacept (PF-07901801) Q3W to characterize safety, tolerability, and PK; to determine the MTD; and to gain preliminary evidence of antitumor activity. Receives: Drug: Maplirpacept (PF-07901801) |
| Cohort A: maplirpacept (PF-07901801) + Azacitidine | Experimental | Cohort A1: participants with newly diagnosed TP53-mutated Acute Myelocytic Leukemia (AML) will be treated with maplirpacept (PF-07901801) QW + azacitidine.
Cohort A2: participants with newly diagnosed TP53-mutated AML will be treated with maplirpacept (PF-07901801) QW + azacitidine. Receives: Drug: Maplirpacept (PF-07901801); Drug: Azacitidine |
| Cohort B: maplirpacept (PF-07901801) + Azacitidine and Venetoclax | Experimental | Cohort B1: elderly or unfit participants with newly diagnosed TP53-wildtype AML will be treated with maplirpacept (PF-07901801) QW + azacitidine and venetoclax
Cohort B2: elderly or unfit participants with newly diagnosed TP53-wildtype AML will be treated with maplirpacept (PF-07901801) QW + azacitidine and venetoclax. Receives: Drug: Maplirpacept (PF-07901801); Drug: Azacitidine; Drug: Venetoclax |
| Cohort D1 and D2: maplirpacept (PF-07901801) + an anti-CD20 targeting agent | Experimental | Cohort D1: participants with Relapsing or Recurrent (R/R) CD20+ Diffuse Large B Cell Lymphoma (DLBCL) will be treated with maplirpacept (PF-07901801) QW, then an increased dose Q3W + an anti-CD20 targeting agent.
Cohort D2: participants with R/R CD20+ DLBCL will be treated with maplirpacept (PF-07901801) dosed QW for 4 weeks, then an increased dose Q3W + an anti-CD20 targeting agent. Receives: Drug: Maplirpacept (PF-07901801); Drug: Anti-CD20 Targeting agent |
| Cohort E1 and E2: single agent maplirpacept (PF-07901801) | Experimental | Cohort E1: participants with Relapsing or Recurrent (R/R) Multiple Myeloma (MM) will be treated with single agent maplirpacept (PF-07901801) QW.
Cohort E2: participants with R/R MM will be treated with single agent maplirpacept (PF-07901801) increased dose QW. Receives: Drug: Maplirpacept (PF-07901801) |
| Cohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone | Experimental | Cohort F1: participants with Relapsing or Recurrent (R/R) Multiple Myeloma (MM) will be treated with increasing doses of maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone.
Cohort F2: participants with R/R MM will be treated with maplirpacept (PF-07901801) QW + isatuximab, carfilzomib and dexamethasone.
Cohort F3: participants with R/R MM will be treated with maplirpacept (PF-07901801) increased dose QW + isatuximab, carfilzomib and dexamethasone. Receives: Drug: Maplirpacept (PF-07901801); Drug: Carfilzomib; Drug: Dexamethasone; Drug: Isatuximab |
| Cohort C1, C2 and C3: maplirpacept (PF-07901801) + Carfilzomib and Dexamethasone | Experimental | Cohort C1: participants with Relapsing or Refractory (R/R) Multiple Myeloma (MM) will be treated with maplirpacept (PF-07901801) QW
+ carfilzomib and dexamethasone.
Cohort C2: participants with R/R MM will be treated with maplirpacept (PF-07901801) QW + carfilzomib and dexamethasone.
Cohort C3: participants with R/R MM will be treated with maplirpacept (PF-07901801) Q2W + carfilzomib and dexamethasone. Receives: Drug: Maplirpacept (PF-07901801); Drug: Carfilzomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Number of adverse events (AE) by severity
To characterize the safety profile (incidence of AEs)
Measured: Through study completion, up to 18 months
Phase 1a: Number of AEs by Frequency
To characterize the safety profile (incidence of AEs) and
Measured: Through study completion, up to 18 months
Phase 1a: Number of participants with Dose-Limiting Toxicities (DLT)
To characterize the dose limiting toxicities (DLTs) of TTI-622.
Measured: Up to 21-42 days
Phase 1b: Number of adverse events (AE) by severity
To characterize the safety profile (incidence of AEs) of TTI-622 given in combinations or as a single agent.
Measured: Through study completion, up to 30 months
Phase 1b: Number of adverse events (AE) by frequency
To characterize the safety profile (incidence of AEs) of TTI-622 given in combination or as a single agent.
Measured: Through study completion, up to 30 months
Phase 1b: Number of participants with disease response
To evaluate response rate of each combination treatment in the (7) combination cohorts (A1,A2, B1, B2, C1, C2, C3, D1, D2, F1, F2, F3) and for single agent treatment (Cohort E1 and E2). For AML, response = CR. For MM, response = CR+sCR+VGBR+PR. For DLBCL, OR=CR+PR
Measured: Through study completion, up to 30 months
Phase 1a: Maximum Tolerated Dose (MTD)
To characterize the highest dose level for which no more than 1 participant in a dose cohort experienced DLTs.
Measured: Baseline (the start of each sequentially increased treatment dose), up to the 3rd evaluable patient completes DLT observation period of 21 or 42 days.
Phase 1b: Recommended dose of TTI-622 in combination with selected anticancer treatments
To characterize the recommended dose of TTI-622 in combination with selected anticancer treatments in 5 patient populations:
- TTI-622 plus azacitidine in newly diagnosed TP53-mutated AML
- TTI-622 plus azacitidine and venetoclax in elderly (>/= 75 years old) or unfit, newly diagnosed TP53-wildtype AML
- TTI-622 plus Carfilzomib and dexamethasone in Carfilzomib-refractory, Relapsed/Refractory (R/R) multiple myeloma (MM) after 3 or more prior lines of therapy
- TTI-622 plus an anti-CD20 targeting agent (such as ruxience or rituxan) in R/R CD20+ DLBCL after 1 or more prior lines of therapy
- TTI-622 plus isatuximab, carfilzomib and dexamethasone in R/R MM after 1-3 prior lines of therapy
Measured: Through study completion, up to 30 months
Phase 1b: Recommended dose of TTI-622 as a single agent
To characterize the recommended dose of TTI-622 as a single agent in patients with R/R MM after 3 or more prior lines of therapy.
Measured: Through study completion, up to 30 months
Number of participants with response assessments that show preliminary efficacy
To evaluate preliminary efficacy of each combination treatment in the selected patient populations and for single-agent treatment in R/R MM
Measured: Through study completion, up to 30 months
Secondary outcomes (16)
Phase 1a: TTI-622 PK parameter AUC0-t
To characterize AUC0-t of TTI-622.
Measured: Through study completion, up to 18 months
Phase 1a: TTI-622 PK parameter Cmax
To characterize Cmax of TTI-622.
Measured: Through study completion, up to 18 months
Phase 1a: Incidence of anti-drug antibodies (ADA)
To characterize the immunogenicity of TTI-622.
Measured: Through study completion, up to 18 months
Phase 1a: Number of participants with overall response rate (ORR) for participants treated with TTI-622.
To determine the disease response.
Measured: Through study completion, up to 18 months
Phase 1a: Number of participants with disease control rate (DCR)
To determine the disease control rate (DCR) for participants treated with TTI-622.
Measured: Through study completion, up to 18 months
Phase 1a: Time to response (TTR)
To determine the time to response (TTR) for participants treated with TTI-622.
Measured: Through study completion, up to 18 months
Phase 1a: Duration of Response (DR)
To determine the duration of response (DR) for participants treated with TTI-622.
Measured: Through study completion, up to 18 months
Phase 1a: Progression free survival (PFS)
To determine the progression free survival (PFS) time for participants treated with TTI-622.
Measured: Through study completion, up to 18 months
Phase 1b: TTI-622 PK parameter Cmax when combined with selected anticancer treatments or as a single agent
To characterize Cmax of TTI-622 when combined with selected anticancer treatments or as a single agent.
Measured: Through study completion, up to 30 months
Phase 1b: incidence of anti-drug antibodies (ADA) Immunogenicity of TTI-622 when combined with selected anticancer treatments or as a single agent
To characterize the immunogenicity of TTI-622 when combined with selected anticancer treatments or as a single agent
Measured: Through study completion, up to 30 months
Phase 1b: Number of participants with disease control rate (DCR)
To determine the disease control rate (DCR) for participants treated with TTI-622 when combined with selected anticancer treatments or as a single agent.
Measured: Through study completion, up to 30 months
Phase 1b: Time to response (TTR)
To determine the time to response (TTR) for participants treated with TTI-622 when combined with selected anticancer treatments or as a single agent.
Measured: Through study completion, up to 30 months
Phase 1b: Event-free survival (EFS)
To determine event-free survival (EFS; for Cohorts A and B) time for participants treated with TTI-622 when combined with selected anticancer treatments or as a single agent.
Measured: Through study completion, up to 30 months
Phase 1b: Duration of response (DR)
To determine the duration of response (DOR) for participants treated with TTI-622 when combined with selected anticancer treatments or as a single agent.
Measured: Through study completion, up to 30 months
Phase 1b: Progression-free survival (PFS)
To determine the progression-free survival (PFS) time for participants treated with TTI-622 when combined with selected anticancer treatments or as a single agent.
Measured: Through study completion, up to 30 months
Phase 1b: Number of Participants With Minimal Residual Disease Burden (MRD) Positive, Negative and Not Evaluable (NE) Status
To determine minimal residual disease (MRD; for Cohorts A, B, C , E and F) for participants treated with TTI-622 when combined with selected anticancer treatments or as a single agent.
Measured: Through study completion, up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start14 May 2018
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Why it stopped: A business decision was made by Pfizer to terminate the study. Termination was not due to any safety concerns, requests from regulatory authorities, changes to the benefit/risk profile or any new concerns regarding the investigational product.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530683
- Sponsor's protocol ID
- TTI-622-01
- Other IDs
- C4971001
- Status last verified
- Aug 2024
- First submitted
- 8 May 2018
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Dose-Escalation and Expansion Trial of TTI-622 in Patients With Advanced Hematologic Malignancies, Including Lymphoma, Leukemia, and Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03530683
- Acronym / sponsor ID
- TTI-622-01
- Keywords
- Neoplasms, Lymphoma, Myeloma, Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A business decision was made by Pfizer to terminate the study. Termination was not due to any safety concerns, requests from regulatory authorities, changes to the benefit/risk profile or any new concerns regarding the investigational product.
- Enrolment
- 189 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 14 May 2018 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to learn how the experimental medicine maplirpacept (PF-07901801) affects people with various types of blood cancers:
- relapsed or refractory (R/R) lymphoma
- multiple myeloma
- newly diagnosed acute myeloid leukemia (AML).
This trial will be conducted in the outpatient setting in 2 parts, phase 1a and phase 1b. You may only participate in one part of the study.
During phase 1a of this study, we will explore how much maplirpacept (PF-07901801), when used by itself, can be safely used.
If you have lymphoma, the study medicine maplirpacept (PF-07901801) will be given by infusion through a vein once a week or once every 2 weeks or every 3 weeks as determined by your doctor. Following your first dose, you will be expected to come back twice more the first week. From week 2, you will have weekly visits for blood tests, questions about your medications, any side effects, or illnesses you may have experienced and your cancer response. After you have completed 21 days (for every week dosing) or 42 days (for every 2- or 3-weeks dosing), your doctor will discuss whether you should stop study treatment or continue.
If you continue, you will be expected to come back weekly for blood tests, vital signs, a brief physical exam, asked about any side effects or illnesses you may have experienced and medications you may be taking. The dosing schedule you are assigned to will continue until your disease has worsened, significant side effects occur or other reasons that lead you and your doctor to decide treatment may be stopped.
To be eligible for the first part of the study you must be 18 years or older, your disease has worsened after receiving other medicines approved for blood cancer, no other treatment options exist for you, a sample of your tissue for exploratory research which can be taken from tissue already obtained or if necessary, a new sample of your tissue will be taken so your disease may be seen and measured on routine tests/scans. If you have had radiation therapy or received any anticancer medication within 14 days before the planned start of study treatment your doctor will let you know if you are eligible to participate in the study. If you have had major surgery within 30 days before the planned start of study treatment you may not be eligible to participate.
The phase 1a part of the study may last up to 51/2 years. How long you participate in this study depends on side effects you may have to the study drug. It also depends on how your cancer responds to the study drug. Therefore, you may remain in the study as long as you and your study doctor think you may benefit. However, you are free to stop taking part in this study at any time and for any reason.
During phase 1b part of this study, we will explore how much maplirpacept (PF-07901801), when used with other anticancer medicine(s), can be safe and reduce cancer growth. In the phase 1b part of this study, you will receive maplirpacept (PF-07901801) and other anticancer medicine(s). Which medicine combination you will receive depends on the types of cancer under treatment. Your treatment experiences will be examined to determine if maplirpacept (PF-07901801) when given with other anticancer medicine(s), is safe and can reduce cancer growth.
To be eligible for the second part of the study you may have newly diagnosed Acute Myelocytic Leukemia with or without a genetic mutation or you have Multiple Myeloma or Diffuse Large B Cell Lymphoma, and your disease has worsened.
The Phase 1b part of this study may last as long as you and your study doctor think you may benefit which could be up to approximately 31/2 years. How long you participate in this study depends on side effects you may have to the study drug. It also depends on how your cancer responds to the study drug. Therefore, you may remain in the study as long as you and your study doctor think you may benefit. However, you are free to stop taking part in this study at any time and for any reason.
Detailed description
This is a trial of maplirpacept (PF-07901801) in subjects with relapsed or refractory lymphoma or multiple myeloma (MM) and subjects with newly diagnosed acute myeloid leukemia (AML).
This trial will be conducted in 2 phases: Phase 1a (Dose-Escalation Phase for Single-Agent maplirpacept (PF-07901801) and Phase 1b maplirpacept (PF-07901801) Combinations and Single-Agent.
In the Dose-Escalation Phase for Single-Agent maplirpacept (PF-07901801), subjects with relapsed or refractory lymphoma will be enrolled in sequential dose cohorts.
In the Combination and Single-Agent Treatment part, subjects will be included in 1 of 14 cohorts: (Cohort A1 and A2) subjects with newly diagnosed TP53-mutated AML will be treated with maplirpacept (PF-07901801) + azacitidine; (Cohort B1 and B2) elderly subjects or subjects unfit for intensive induction chemotherapies with newly diagnosed TP53-wildtype AML will be treated with maplirpacept (PF-07901801) + azacitidine and venetoclax; (Cohort C1, C2, and C3) subjects with relapsed or refractory MM will be treated with maplirpacept (PF-07901801) + carfilzomib and dexamethasone;(Cohort D1 and D2) subjects in relapsed or refractory CD20+ diffuse large B-cell lymphoma will be treated with maplirpacept (PF-07901801) + an anti-CD20 targeting agent; (Cohort E1 and E2) subjects with relapsed refractory MM will be treated with single-agent maplirpacept (PF-07901801); and (Cohorts F1, F2 and F3) with relapsing or refractory MM will be treated with increasing doses of maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| maplirpacept (PF-07901801) Monotherapy | Experimental | Drug: Maplirpacept (PF-07901801)In the phase 1a dose- escalation part for single-agent maplirpacept (PF-07901801), participants with Relapsing or Refractory (R/R) lymphoma will be enrolled in sequential dose cohorts to receive maplirpacept (PF-07901801) QW to characterize safety, tolerability, and PK; to determine the Maximum Tolerated Dose (MTD) or P1b Starting Dose (a dose lower than or equal to the single-agent MTD), and to gain preliminary evidence of antitumor activity. In addition, participants with R/R Lymphoma may also be enrolled in a cohort to receive maplirpacept (PF-07901801) Q2W and a cohort to receive maplirpacept (PF-07901801) Q3W to characterize safety, tolerability, and PK; to determine the MTD; and to gain preliminary evidence of antitumor activity. |
| Cohort A: maplirpacept (PF-07901801) + Azacitidine | Experimental | Drug: Maplirpacept (PF-07901801), Drug: AzacitidineCohort A1: participants with newly diagnosed TP53-mutated Acute Myelocytic Leukemia (AML) will be treated with maplirpacept (PF-07901801) QW + azacitidine. Cohort A2: participants with newly diagnosed TP53-mutated AML will be treated with maplirpacept (PF-07901801) QW + azacitidine. |
| Cohort B: maplirpacept (PF-07901801) + Azacitidine and Venetoclax | Experimental | Drug: Maplirpacept (PF-07901801), Drug: Azacitidine, Drug: VenetoclaxCohort B1: elderly or unfit participants with newly diagnosed TP53-wildtype AML will be treated with maplirpacept (PF-07901801) QW + azacitidine and venetoclax Cohort B2: elderly or unfit participants with newly diagnosed TP53-wildtype AML will be treated with maplirpacept (PF-07901801) QW + azacitidine and venetoclax. |
| Cohort D1 and D2: maplirpacept (PF-07901801) + an anti-CD20 targeting agent | Experimental | Drug: Maplirpacept (PF-07901801), Drug: Anti-CD20 Targeting agentCohort D1: participants with Relapsing or Recurrent (R/R) CD20+ Diffuse Large B Cell Lymphoma (DLBCL) will be treated with maplirpacept (PF-07901801) QW, then an increased dose Q3W + an anti-CD20 targeting agent. Cohort D2: participants with R/R CD20+ DLBCL will be treated with maplirpacept (PF-07901801) dosed QW for 4 weeks, then an increased dose Q3W + an anti-CD20 targeting agent. |
| Cohort E1 and E2: single agent maplirpacept (PF-07901801) | Experimental | Drug: Maplirpacept (PF-07901801)Cohort E1: participants with Relapsing or Recurrent (R/R) Multiple Myeloma (MM) will be treated with single agent maplirpacept (PF-07901801) QW. Cohort E2: participants with R/R MM will be treated with single agent maplirpacept (PF-07901801) increased dose QW. |
| Cohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone | Experimental | Drug: Maplirpacept (PF-07901801), Drug: Carfilzomib, Drug: Dexamethasone, Drug: IsatuximabCohort F1: participants with Relapsing or Recurrent (R/R) Multiple Myeloma (MM) will be treated with increasing doses of maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone. Cohort F2: participants with R/R MM will be treated with maplirpacept (PF-07901801) QW + isatuximab, carfilzomib and dexamethasone. Cohort F3: participants with R/R MM will be treated with maplirpacept (PF-07901801) increased dose QW + isatuximab, carfilzomib and dexamethasone. |
| Cohort C1, C2 and C3: maplirpacept (PF-07901801) + Carfilzomib and Dexamethasone | Experimental | Drug: Maplirpacept (PF-07901801), Drug: Carfilzomib, Drug: DexamethasoneCohort C1: participants with Relapsing or Refractory (R/R) Multiple Myeloma (MM) will be treated with maplirpacept (PF-07901801) QW + carfilzomib and dexamethasone. Cohort C2: participants with R/R MM will be treated with maplirpacept (PF-07901801) QW + carfilzomib and dexamethasone. Cohort C3: participants with R/R MM will be treated with maplirpacept (PF-07901801) Q2W + carfilzomib and dexamethasone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maplirpacept (PF-07901801)Also: SIRPα-IgG4 Fc, TTI-622maplirpacept (PF-07901801) will be administered by intravenous infusion at ranging doses, as determined from sequential dosing cohorts. | Drug | Cohort A: maplirpacept (PF-07901801) + Azacitidine, Cohort B: maplirpacept (PF-07901801) + Azacitidine and Venetoclax, Cohort C1, C2 and C3: maplirpacept (PF-07901801) + Carfilzomib and Dexamethasone, Cohort D1 and D2: maplirpacept (PF-07901801) + an anti-CD20 targeting agent, Cohort E1 and E2: single agent maplirpacept (PF-07901801), Cohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone, maplirpacept (PF-07901801) Monotherapy |
| AzacitidineAlso: VIDAZAintravenous (IV) or subcutaneous (SC) daily for 7 days, repeated every 4 weeks | Drug | Cohort A: maplirpacept (PF-07901801) + Azacitidine, Cohort B: maplirpacept (PF-07901801) + Azacitidine and Venetoclax |
| VenetoclaxAlso: VENCLEXTAorally daily for each day of each cycle (first 7 doses taken in clinic). The ramp-up and target dose of venetoclax will be adjusted per the package insert in subjects who are taking concomitant moderate or strong CYP3A4 inhibitors or posaconazole | Drug | Cohort B: maplirpacept (PF-07901801) + Azacitidine and Venetoclax |
| CarfilzomibAlso: KYPROLISDays 1, 8, and 15 of 28-day cycles; starting dose IV given on Cycle (C) 1 Day (D) 1, and if tolerated, then increased dose via IV given starting on C1D8 and subsequent doses thereafter. | Drug | Cohort C1, C2 and C3: maplirpacept (PF-07901801) + Carfilzomib and Dexamethasone, Cohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone |
| Dexamethasonestarting dose via IV on Days 1, 8, 15, and increased dose via IV on 28-day cycles | Drug | Cohort C1, C2 and C3: maplirpacept (PF-07901801) + Carfilzomib and Dexamethasone, Cohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone |
| Anti-CD20 Targeting agentAlso: Ruxience or RituxanDays 1,8,15, and 22 of the first 28-day cycle and then on Day 1 of subsequent 21-day cycles. The anti-CD20 targeting agent will be administered for a total of eight doses, and then Cohort F1, F2 and F3: TTI-622 + isatuximab, carfilzomib and dexamethasone Cohort C1, C2 and C3: TTI-622 + Carfilzomib and Dexamethasone will be continued as single-agent therapy. | Drug | Cohort D1 and D2: maplirpacept (PF-07901801) + an anti-CD20 targeting agent |
| IsatuximabAlso: SarclisaF1: IV dose C0D1, C0D8, C0D15 and C0D22 (lead in phase);weekly during Cycle 1; Cycle 2 and beyond will be administered on Days 1 and 15 (Q2W). F2 and F3: IV dose C0D1 and C0D8 (lead in phase); C1D1, C1D8, C1D15 and C1D22; Cycle 2 and beyond will be administered on days 1 and 15 (Q2W). Carfilzomib: IV dose on days 1 and 2 of cycle 1; then increased IV dose on days 8, 9, 15, and 16 of cycle 1; cycle 2 and beyond: increased IV dose on days 1, 2, 8, 9, 15, and 16. Dexamethasone IV or PO on days 1, 2, 8, 9, 15, 16, 22, and 23 starting cycle 1. | Drug | Cohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone |
Primary outcome
Phase 1a: Number of adverse events (AE) by severity
Time frame: Through study completion, up to 18 months
To characterize the safety profile (incidence of AEs)
Phase 1a: Number of AEs by Frequency
Time frame: Through study completion, up to 18 months
To characterize the safety profile (incidence of AEs) and
Phase 1a: Number of participants with Dose-Limiting Toxicities (DLT)
Time frame: Up to 21-42 days
To characterize the dose limiting toxicities (DLTs) of TTI-622.
Phase 1b: Number of adverse events (AE) by severity
Time frame: Through study completion, up to 30 months
To characterize the safety profile (incidence of AEs) of TTI-622 given in combinations or as a single agent.
Phase 1b: Number of adverse events (AE) by frequency
Time frame: Through study completion, up to 30 months
To characterize the safety profile (incidence of AEs) of TTI-622 given in combination or as a single agent.
Phase 1b: Number of participants with disease response
Time frame: Through study completion, up to 30 months
To evaluate response rate of each combination treatment in the (7) combination cohorts (A1,A2, B1, B2, C1, C2, C3, D1, D2, F1, F2, F3) and for single agent treatment (Cohort E1 and E2). For AML, response = CR. For MM, response = CR+sCR+VGBR+PR. For DLBCL, OR=CR+PR
Phase 1a: Maximum Tolerated Dose (MTD)
Time frame: Baseline (the start of each sequentially increased treatment dose), up to the 3rd evaluable patient completes DLT observation period of 21 or 42 days.
To characterize the highest dose level for which no more than 1 participant in a dose cohort experienced DLTs.
Phase 1b: Recommended dose of TTI-622 in combination with selected anticancer treatments
Time frame: Through study completion, up to 30 months
To characterize the recommended dose of TTI-622 in combination with selected anticancer treatments in 5 patient populations: * TTI-622 plus azacitidine in newly diagnosed TP53-mutated AML * TTI-622 plus azacitidine and venetoclax in elderly (>/= 75 years old) or unfit, newly diagnosed TP53-wildtype AML * TTI-622 plus Carfilzomib and dexamethasone in Carfilzomib-refractory, Relapsed/Refractory (R/R) multiple myeloma (MM) after 3 or more prior lines of therapy * TTI-622 plus an anti-CD20 targeting agent (such as ruxience or rituxan) in R/R CD20+ DLBCL after 1 or more prior lines of therapy * TTI-622 plus isatuximab, carfilzomib and dexamethasone in R/R MM after 1-3 prior lines of therapy
Phase 1b: Recommended dose of TTI-622 as a single agent
Time frame: Through study completion, up to 30 months
To characterize the recommended dose of TTI-622 as a single agent in patients with R/R MM after 3 or more prior lines of therapy.
Number of participants with response assessments that show preliminary efficacy
Time frame: Through study completion, up to 30 months
To evaluate preliminary efficacy of each combination treatment in the selected patient populations and for single-agent treatment in R/R MM
16 secondary outcomes
Phase 1a: TTI-622 PK parameter AUC0-t
Time frame: Through study completion, up to 18 months
Phase 1a: TTI-622 PK parameter Cmax
Time frame: Through study completion, up to 18 months
Phase 1a: Incidence of anti-drug antibodies (ADA)
Time frame: Through study completion, up to 18 months
Phase 1a: Number of participants with overall response rate (ORR) for participants treated with TTI-622.
Time frame: Through study completion, up to 18 months
Phase 1a: Number of participants with disease control rate (DCR)
Time frame: Through study completion, up to 18 months
Phase 1a: Time to response (TTR)
Time frame: Through study completion, up to 18 months
Phase 1a: Duration of Response (DR)
Time frame: Through study completion, up to 18 months
Phase 1a: Progression free survival (PFS)
Time frame: Through study completion, up to 18 months
Phase 1b: TTI-622 PK parameter Cmax when combined with selected anticancer treatments or as a single agent
Time frame: Through study completion, up to 30 months
Phase 1b: incidence of anti-drug antibodies (ADA) Immunogenicity of TTI-622 when combined with selected anticancer treatments or as a single agent
Time frame: Through study completion, up to 30 months
Phase 1b: Number of participants with disease control rate (DCR)
Time frame: Through study completion, up to 30 months
Phase 1b: Time to response (TTR)
Time frame: Through study completion, up to 30 months
Phase 1b: Event-free survival (EFS)
Time frame: Through study completion, up to 30 months
Phase 1b: Duration of response (DR)
Time frame: Through study completion, up to 30 months
Phase 1b: Progression-free survival (PFS)
Time frame: Through study completion, up to 30 months
Phase 1b: Number of Participants With Minimal Residual Disease Burden (MRD) Positive, Negative and Not Evaluable (NE) Status
Time frame: Through study completion, up to 30 months
Results and safety
The study was stopped early (reason given: A business decision was made by Pfizer to terminate the study. Termination was not due to any safety concerns, requests from regulatory authorities, changes to the benefit/risk profile or any new concerns regarding the investigational product.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Maplirpacept (PF-07901801), Azacitidine and Venetoclax in people with Lymphoma and Multiple Myeloma, run by Pfizer at 62 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: A business decision was made by Pfizer to terminate the study. Termination was not due to any safety concerns, requests from regulatory authorities, changes to the benefit/risk profile or any new concerns regarding the investigational product.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: Number of adverse events (AE) by severity (time frame: Through study completion, up to 18 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.