Relapsed Lymphoid MalignancyPhase 1NCT02175433
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies
A Phase 1 study testing AGS67E in people with Relapsed Lymphoid Malignancy and Refractory Lymphoid Malignancy, run by Astellas Pharma Global Development, Inc. at 5 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AGS67E both without and with myeloid growth factor (GF) in subjects with refractory or relapsed lymphoid malignancies. Immunogenicity and anticancer activity of AGS67E will also be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Lymphoid Malignancy, Refractory Lymphoid Malignancy
- What is being tested?
- AGS67E
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 14 Oct 2014to 29 Oct 2019
- 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
Who may be able to join
- Refractory or relapsed chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL), hairy cell leukemia (HCL) or non-Hodgkin lymphoma (NHL) (including those of T cell origin)
- Eastern Cooperative Oncology Group performance score (ECOG) ≤ 2
- Negative pregnancy test (women of childbearing potential)
- Hematologic function, as follows (no platelet transfusion within 2 weeks and no RBC transfusion within 4 days before the first dose of study drug)
- Absolute neutrophil count (ANC) ≥ 1,000/μL
- Platelets ≥ 75,000/μL
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- Hemoglobin ≥ 8 g/dL (may be transfused ≥ 5 days)
- Renal function: serum creatinine ≤ 2.0 mg/dL and estimated creatinine clearance of ≥ 45 mL/min by the Cockcroft-Gault equation
- Direct bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Serum albumin ≥ 2.5 g/dL
- Aspartate aminotransferase (AST) ≤ 1.5 x ULN unless there is hepatic involvement, then 3 x ULN
- Alanine aminotransferase (ALT) ≤ 1.5 x ULN unless there is hepatic involvement, then 3 x ULN
- Sexually active fertile subjects, and their partners, must agree to use medically accepted double-barrier methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and at least 6 weeks after termination of study therapy
Who cannot join
- Preexisting sensory and/or motor neuropathy Grade ≥ 2
- Small molecule therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 2 weeks before first dose of study drug
- Radioimmunotherapy within 4 weeks before first dose of study drug
- Use of any investigational drug (including marketed drugs not approved for this indication) within 14 days prior to the first dose of study drug
- Any P-gp inducers/inhibitors or strong CYP3A inhibitors within 2 weeks before the first dose of study drug (See Appendix F for list of excluded drugs)
- Anti Graft-Versus-Host Disease (GVHD) therapy within 12 weeks before the first dose of study drug
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- Platelet transfusion within 2 weeks and RBC transfusion within 4 days before the first dose of study drug
- Known central nervous system (CNS) disease
- History of other primary malignancy (including myeloid malignancy, e.g., myelodysplastic syndrome), unless
- Curatively resected nonmelanomatous skin cancer
- Other malignancy curatively treated with no known active disease present and no systemic treatment administered for 3 years before the first dose of study drug
- Active angina or Class III or IV Congestive Heart Failure (CHF) (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of the first dose of study drug, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrhythmias not controlled by outpatient medication
- Women who are pregnant or lactating
- Known HIV positive or AIDS
- Positive Hepatitis B surface antigen test
- Decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy
- Known sensitivity to any of the components of the investigational product AGS67E:
- AGS67E
- L-Histidine
- α-trehalose dihydrate or
- polysorbate 20
- History of thromboembolic events (e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE)) ≤ 2 weeks before the first dose of study drug and/or clinical diffuse intravascular coagulation (DIC)
- Active infection requiring treatment ≤7 days before the first dose of study drug
- Condition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study
- Any medical, psychiatric, addictive or other disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Site US0006
Duarte, California, 91010
Site US0004
Fairway, Kansas, 66205
Site US0001
New York, New York, 10019
Site US0002
Stanford, California, 94305
About this study
Official title: A Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AGS67E both without and with myeloid growth factor (GF) in subjects with refractory or relapsed lymphoid malignancies. Immunogenicity and anticancer activity of AGS67E will also be assessed.
Read the detailed description
The dose escalation study will have two parts:
- Dose Escalation of AGS67E without myeloid growth factor (GF)
- Dose Escalation of AGS67E with myeloid growth factor (GF)
Subjects will be enrolled sequentially into dose cohorts starting with AGS67E without GF.
All subjects will receive a single 30 minute intravenous (IV) infusion of AGS67E once every three weeks. Subjects will continue treatment until disease progression, intolerability of AGS67E, investigator decision or consent withdrawal.
This dose escalation will first determine the maximum tolerated dose (MTD) of AGS67E without GF and then determine the MTD of AGS67E with GF. Once an MTD has been established, the study may enroll subjects into respective expansion cohorts of 12 subjects each at doses recommended by the data review team (DRT) (expansion cohort without GF and/or expansion cohort with GF).
During dose escalation, the Data Review Team will review cumulative unaudited data on an interim basis to review subject safety, recommend exploring additional doses and/or schedules, or the expansion of existing cohorts.
- Being tested
- AGS67E
- Keywords
- Refractory or relapsed chronic lymphocytic leukemia (CLL) prolymphocytic leukemia (PLL), Relapsed lymphoid malignancy, Refractory lymphoid malignancy, Pharmacokinetics of AGS67E, hairy cell leukemia (HCL), AGS67C, non-Hodgkin lymphoma (NHL), AGS67E
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Prolymphocytic, Leukemia, Hairy Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGS67EDrug
intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation of AGS67E 0.05 mg/kg Without GF | Experimental | Participants will receive 0.05 milligram per kilogram (mg/kg) AGS67E without growth factor (GF) by intravenous infusion once every three weeks. Receives: Drug: AGS67E |
| Dose Escalation of AGS67E 0.1 mg/kg Without GF | Experimental | Participants will receive 0.1 mg/kg AGS67E without GF by intravenous infusion once every three weeks. Receives: Drug: AGS67E |
| Dose Escalation of AGS67E 0.3 mg/kg Without GF | Experimental | Participants will receive 0.3 mg/kg AGS67E without GF by intravenous infusion once every three weeks. Receives: Drug: AGS67E |
| Dose Escalation of AGS67E 0.6 mg/kg Without GF | Experimental | Participants will receive 0.6 mg/kg AGS67E without GF by intravenous infusion once every three weeks. Receives: Drug: AGS67E |
| Dose Escalation of AGS67E 0.9 mg/kg Without GF | Experimental | Participants will receive 0.9 mg/kg AGS67E without GF by intravenous infusion once every three weeks. Receives: Drug: AGS67E |
| Dose Escalation of AGS67E 1.2 mg/kg Without GF | Experimental | Participants will receive 1.2 mg/kg AGS67E without GF by intravenous infusion once every three weeks. Receives: Drug: AGS67E |
| Dose Expansion of AGS67E 0.9 mg/kg Without GF | Experimental | Participants will receive 0.9 mg/kg AGS67E without GF by intravenous infusion once every three weeks. Receives: Drug: AGS67E |
| Dose Escalation of AGS67E 1.2 mg/kg With GF | Experimental | Participants will receive 1.2 mg/kg AGS67E with GF by intravenous infusion once every three weeks. Receives: Drug: AGS67E |
| Dose Escalation of AGS67E 1.5 mg/kg With GF | Experimental | Participants will receive 1.5 mg/kg AGS67E with GF by intravenous infusion once every three weeks. Receives: Drug: AGS67E |
| Dose Escalation of AGS67E 1.8 mg/kg With GF | Experimental | Participants will receive 1.8 mg/kg AGS67E with GF by intravenous infusion once every three weeks. Receives: Drug: AGS67E |
| Dose Expansion of AGS67E 1.5 mg/kg With GF | Experimental | Participants will receive 1.5 mg/kg AGS67E with GF by intravenous infusion once every three weeks. Receives: Drug: AGS67E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of adverse events
Measured: up to 34 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Concentration at the end of infusion (CEOI)
Measured: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Maximum observed concentration (Cmax)
Measured: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
Pharmacokinetic parameter for Monomethyl Auristatin E (MMAE): Time to maximum concentration (Tmax)
Measured: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Partial area under the serum concentration-time curve after first dose and as appropriate (AUC0-21)
Measured: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Terminal or apparent terminal half-life (t1/2)
Measured: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Systemic clearance (CL)
Measured: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Volume of distribution at steady state (Vss)
Measured: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
Secondary outcomes (3)
Incidence of Anti-Drug Antibody (ADA) formation to the fully human monoclonal antibody (AGS67C) and antibody-drug conjugate (AGS67E)
Measured: Up to 34 months
Incidence of tumor response
Tumor response is defined as either a complete response (CR) or partial response (PR)
Measured: Up to 34 months
Objective response rate (ORR)
ORR for a cohort is defined as the percentage of subjects who experience a best response of either complete response (CR) or partial response (PR) in that cohort.
Measured: Up to 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study start14 Oct 2014
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Lymphoid MalignancyStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Associate Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175433
- Sponsor's protocol ID
- AGS67E-14-1
- Status last verified
- Oct 2024
- First submitted
- 24 Jun 2014
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT02175433
- Acronym / sponsor ID
- AGS67E-14-1
- Keywords
- Refractory or relapsed chronic lymphocytic leukemia (CLL) prolymphocytic leukemia (PLL), Relapsed lymphoid malignancy, Refractory lymphoid malignancy, Pharmacokinetics of AGS67E, hairy cell leukemia (HCL), AGS67C, non-Hodgkin lymphoma (NHL), AGS67E
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2014 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 26 Jun 2014 (estimated)
- 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 study is to evaluate the safety, tolerability and pharmacokinetics of AGS67E both without and with myeloid growth factor (GF) in subjects with refractory or relapsed lymphoid malignancies. Immunogenicity and anticancer activity of AGS67E will also be assessed.
Detailed description
The dose escalation study will have two parts:
- Dose Escalation of AGS67E without myeloid growth factor (GF)
- Dose Escalation of AGS67E with myeloid growth factor (GF)
Subjects will be enrolled sequentially into dose cohorts starting with AGS67E without GF.
All subjects will receive a single 30 minute intravenous (IV) infusion of AGS67E once every three weeks. Subjects will continue treatment until disease progression, intolerability of AGS67E, investigator decision or consent withdrawal.
This dose escalation will first determine the maximum tolerated dose (MTD) of AGS67E without GF and then determine the MTD of AGS67E with GF. Once an MTD has been established, the study may enroll subjects into respective expansion cohorts of 12 subjects each at doses recommended by the data review team (DRT) (expansion cohort without GF and/or expansion cohort with GF).
During dose escalation, the Data Review Team will review cumulative unaudited data on an interim basis to review subject safety, recommend exploring additional doses and/or schedules, or the expansion of existing cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation of AGS67E 0.05 mg/kg Without GF | Experimental | Drug: AGS67EParticipants will receive 0.05 milligram per kilogram (mg/kg) AGS67E without growth factor (GF) by intravenous infusion once every three weeks. |
| Dose Escalation of AGS67E 0.1 mg/kg Without GF | Experimental | Drug: AGS67EParticipants will receive 0.1 mg/kg AGS67E without GF by intravenous infusion once every three weeks. |
| Dose Escalation of AGS67E 0.3 mg/kg Without GF | Experimental | Drug: AGS67EParticipants will receive 0.3 mg/kg AGS67E without GF by intravenous infusion once every three weeks. |
| Dose Escalation of AGS67E 0.6 mg/kg Without GF | Experimental | Drug: AGS67EParticipants will receive 0.6 mg/kg AGS67E without GF by intravenous infusion once every three weeks. |
| Dose Escalation of AGS67E 0.9 mg/kg Without GF | Experimental | Drug: AGS67EParticipants will receive 0.9 mg/kg AGS67E without GF by intravenous infusion once every three weeks. |
| Dose Escalation of AGS67E 1.2 mg/kg Without GF | Experimental | Drug: AGS67EParticipants will receive 1.2 mg/kg AGS67E without GF by intravenous infusion once every three weeks. |
| Dose Expansion of AGS67E 0.9 mg/kg Without GF | Experimental | Drug: AGS67EParticipants will receive 0.9 mg/kg AGS67E without GF by intravenous infusion once every three weeks. |
| Dose Escalation of AGS67E 1.2 mg/kg With GF | Experimental | Drug: AGS67EParticipants will receive 1.2 mg/kg AGS67E with GF by intravenous infusion once every three weeks. |
| Dose Escalation of AGS67E 1.5 mg/kg With GF | Experimental | Drug: AGS67EParticipants will receive 1.5 mg/kg AGS67E with GF by intravenous infusion once every three weeks. |
| Dose Escalation of AGS67E 1.8 mg/kg With GF | Experimental | Drug: AGS67EParticipants will receive 1.8 mg/kg AGS67E with GF by intravenous infusion once every three weeks. |
| Dose Expansion of AGS67E 1.5 mg/kg With GF | Experimental | Drug: AGS67EParticipants will receive 1.5 mg/kg AGS67E with GF by intravenous infusion once every three weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Refractory or relapsed chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL), hairy cell leukemia (HCL) or non-Hodgkin lymphoma (NHL) (including those of T cell origin)
- Eastern Cooperative Oncology Group performance score (ECOG) ≤ 2
- Negative pregnancy test (women of childbearing potential)
- Hematologic function, as follows (no platelet transfusion within 2 weeks and no RBC transfusion within 4 days before the first dose of study drug)
- Renal function: serum creatinine ≤ 2.0 mg/dL and estimated creatinine clearance of ≥ 45 mL/min by the Cockcroft-Gault equation
Key exclusion criteria (25 listed)
- Preexisting sensory and/or motor neuropathy Grade ≥ 2
- Small molecule therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 2 weeks before first dose of study drug
- Radioimmunotherapy within 4 weeks before first dose of study drug
- Use of any investigational drug (including marketed drugs not approved for this indication) within 14 days prior to the first dose of study drug
- Any P-gp inducers/inhibitors or strong CYP3A inhibitors within 2 weeks before the first dose of study drug (See Appendix F for list of excluded drugs)
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 |
|---|---|---|
| AGS67Eintravenous (IV) infusion | Drug | Dose Escalation of AGS67E 0.05 mg/kg Without GF, Dose Escalation of AGS67E 0.1 mg/kg Without GF, Dose Escalation of AGS67E 0.3 mg/kg Without GF, Dose Escalation of AGS67E 0.6 mg/kg Without GF, Dose Escalation of AGS67E 0.9 mg/kg Without GF, Dose Escalation of AGS67E 1.2 mg/kg With GF, Dose Escalation of AGS67E 1.2 mg/kg Without GF, Dose Escalation of AGS67E 1.5 mg/kg With GF, Dose Escalation of AGS67E 1.8 mg/kg With GF, Dose Expansion of AGS67E 0.9 mg/kg Without GF, Dose Expansion of AGS67E 1.5 mg/kg With GF |
Primary outcome
Incidence and nature of adverse events
Time frame: up to 34 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Concentration at the end of infusion (CEOI)
Time frame: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Maximum observed concentration (Cmax)
Time frame: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
Pharmacokinetic parameter for Monomethyl Auristatin E (MMAE): Time to maximum concentration (Tmax)
Time frame: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Partial area under the serum concentration-time curve after first dose and as appropriate (AUC0-21)
Time frame: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Terminal or apparent terminal half-life (t1/2)
Time frame: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Systemic clearance (CL)
Time frame: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE): Volume of distribution at steady state (Vss)
Time frame: Escalation: Days 1-4, 8, 15, 22, 43-46, 50, 64 for Cycles 1-4 and predose once every 3 weeks in subsequent cycles. Expansion: Days 1, 3, 8, 22, 43, 45, 64 in Cycles 1-4 and predose once every 3 weeks in subsequent Cycles up to an average of 4 months
3 secondary outcomes
Incidence of Anti-Drug Antibody (ADA) formation to the fully human monoclonal antibody (AGS67C) and antibody-drug conjugate (AGS67E)
Time frame: Up to 34 months
Incidence of tumor response
Time frame: Up to 34 months
Objective response rate (ORR)
Time frame: Up to 34 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Associate Medical Director study director
Astellas Pharma Global Development, Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGS67E in people with Relapsed Lymphoid Malignancy and Refractory Lymphoid Malignancy, run by Astellas Pharma Global Development, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. 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: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and nature of adverse events (time frame: up to 34 months). The study lists 8 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 1 Nov 2024.