Carcinoma, Non-Small-Cell LungPhase 1NCT02376699
Safety Study of SEA-CD40 in Cancer Patients
A Phase 1 study testing Intravenous (IV) SEA-CD40, Pembrolizumab and Subcutaneous (SC) SEA-CD40 in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Squamous Cell, run by Seagen Inc. at 19 sites in United States.
Trial summary
This study is being done to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Hodgkin Disease
- What is being tested?
- Intravenous (IV) SEA-CD40, Pembrolizumab and Subcutaneous (SC) SEA-CD40
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 19 sitesUnited States
- Study dates
- 28 Feb 2015to 14 Apr 2023
- 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
- (Monotherapy - Parts A, B, C, D, G, H, J, and K) -- Histologically confirmed advanced malignancy, either: (a) Metastatic or unresectable solid malignancy; or (b) Classical Hodgkin lymphoma (HL), or diffuse large B-cell lymphoma (DLBCL), or indolent lymphoma (including follicular lymphoma [FL])
- (Monotherapy - Parts A, B, C, D, G, H, J, and K) -- Relapsed, refractory, or progressive disease, specifically: (a) Solid tumors: Following at least 1 prior systemic therapy, and no further standard therapy is available for the patient's advanced solid tumor at the time of enrollment; or (b) Classical HL: Following at least 2 prior systemic therapies in patients who are not candidates for autologous stem cell transplant (SCT), or following failure of autologous SCT; or (c) DLBCL: Following at least 1 prior systemic therapy; patients must have also received intensive salvage therapy unless they refused or were deemed ineligible; or (d) Indolent lymphoma: Following at least 1 prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option exists
- (Combination Therapy - Part E and Part F) -- Histologically or cytologically confirmed advanced or metastatic solid malignancy for which pembrolizumab treatment is approved. In Part F, other advanced solid tumor indications may be eligible as identified by the Sponsor.
- (Pancreatic Cancer Cohort - Part L) - Histologically or cytologically confirmed metastatic exocrine ductal adenocarcinoma of the pancreas not amenable to curative therapy. Patients must not have received any prior systemic therapy for metastatic disease; patients who have received prior therapy for non-metastatic pancreatic adenocarcinoma are eligible if therapy was fully completed more than 4 months before start of study treatment.
- Representative baseline tumor tissue sample is available (Parts A-K)
- Measurable disease
Show all 9Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate baseline hematologic, renal, and hepatic function
- Recovery to Grade 1 of any clinically significant toxicity attributed to prior anticancer therapy prior to initiation of study drug administration
Who cannot join
- Parts A-K
- Prior chemotherapy, small molecule inhibitors, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies) within 4 weeks
- Prior radiotherapy: therapeutic radiotherapy within 4 weeks, or palliative radiotherapy (to non-CNS disease) within 1 week
- Prior immune-checkpoint inhibitors within 4 weeks (or 8 weeks, if immuno-oncology doublet used as the prior line of therapy)
- Prior monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates within 4 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
- Prior T-cell or other cell-based therapies within 12 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
Show all 20Show fewer
- Part L
- History of radiation pneumonitis
- Neuropathy Grade 2 or higher
- Has received prior therapy with an anti-PD-1, anti-PDL1, or anti-PD-L2 agent, with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Has had allogenic tissue/solid organ transplant
- All Parts
- Recent or ongoing serious infections within 2 weeks
- Known positivity for hepatitis B infection
- Known active hepatitis C infection
- Active autoimmune or auto-inflammatory ocular disease within 6 months
- Known or suspected active organ-threatening autoimmune disease
- Active central nervous system tumor or metastases
- Patients with lymphomas: prior allogeneic SCT
- Patients in Part E, F, or L: history of severe immune-mediated adverse reactions or severe hypersensitivity to pembrolizumab
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham
Birmingham, Alabama, 35249
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, 27599
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637-1470
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201
Hackensack University Medical Center
Hackensack, New Jersey, 07601
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
Providence Portland Medical Center
Portland, Oregon, 97213
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Angeles Clinic and Research Institute, The
Santa Monica, California, 90404
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, 85258
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109-1023
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Phase 1, Open-label, Dose-escalation Study of SEA-CD40 in Adult Patients With Advanced Malignancies
This study is being done to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.
Read the detailed description
The study will be conducted in the following parts:
Part A: Intravenous (IV) monotherapy dose-regimen finding for solid tumors -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the IV SEA-CD40 monotherapy maximum tolerated dose (MTD) and/or the optimal biological dose (OBD) regimens in patients with solid tumors. The ability to increase the dose intensity (to give additional doses within a treatment cycle) may be evaluated.
Part B: IV monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD and/or OBD determined in Part A.
Part C: IV monotherapy dose-regimen finding for lymphomas -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the IV SEA-CD40 monotherapy MTD and/or the OBD regimens in patients with lymphomas. The ability to increase the dose intensity (to give additional doses within a treatment cycle) may be evaluated.
Part D: IV monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD and/or OBD determined in Part C.
Part E: Combination therapy dose-regimen finding for solid tumors -- IV SEA-CD40 dose-escalation to define the MTD and/or the OBD regimen to be administered in combination with standard approved dose of pembrolizumab in patients with solid tumors.
Part F: Combination therapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with IV SEA-CD40 and pembrolizumab combination therapy; doses of SEA-CD40 will be at or below the MTD and/or OBD determined in Part E.
Part G: Subcutaneous (SC) injection (injected under the skin) monotherapy dose-regimen finding for solid tumors -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the SC SEA-CD40 monotherapy maximum tolerated dose (MTD) and/or the optimal biological dose (OBD) regimens in patients with solid tumors.
Part H: SC monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD and/or OBD determined in Part G.
(Note: There is no Part I)
Part J: SC monotherapy dose-regimen finding for lymphomas -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the SC SEA-CD40 monotherapy MTD and/or the OBD regimens in patients with lymphomas.
Part K: SC monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD and/or OBD determined in Part J.
Part L: Combination therapy in pancreatic cancer -- Patients will be treated with SEA-CD40 doses at or below MTD and/or OBD. An established dose of pembrolizumab and a standard regimen of gemcitabine and nab-paclitaxel will be used.
In Parts A, C, E, G, and J, a maximum feasible dose (MFD) will be defined if an MTD and/or OBD cannot be identified. Parts B, D, F, H, K. and L will explore the recommended dosing regimen once the MTD and/or OBD, or MFD (if the MTD and/or OBD cannot be identified) has been determined.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Hodgkin Disease, Lymphoma, Lymphoma, B-Cell, Lymphoma, Follicular
- Being tested
- Intravenous (IV) SEA-CD40, Pembrolizumab, Subcutaneous (SC) SEA-CD40, Gemcitabine, Nab-paclitaxel
- Keywords
- CD40 Antigen, Drug Therapy, Follicular Lymphoma, Hodgkin Disease, Immunotherapy, Indolent Lymphoma, Lymphoma, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Monoclonal Antibody, Neoplasms, Neoplasm Metastasis, Solid tumor, Seattle Genetics
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Hodgkin Disease, Lymphoma, Lymphoma, B-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous (IV) SEA-CD40Drug
Also called SEA-CD40
Given intravenously; schedule is cohort-specific.
PembrolizumabDrug
Also called Keytruda
Given intravenously; schedule is cohort-specific.
Subcutaneous (SC) SEA-CD40Drug
Also called SEA-CD40
Given subcutaneously on Day 1 every 3 weeks
GemcitabineDrug
Also called Gemzar
1000 mg/m^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle
Nab-paclitaxelDrug
Also called Abraxane
125 mg/m^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| IV Monotherapy in Solid Tumors | Experimental | SEA-CD40 administered IV Receives: Drug: Intravenous (IV) SEA-CD40 |
| IV Monotherapy in Lymphomas | Experimental | SEA-CD40 administered IV Receives: Drug: Intravenous (IV) SEA-CD40 |
| Combination Therapy in Solid Tumors | Experimental | SEA-CD40 (administered IV) + pembrolizumab Receives: Drug: Intravenous (IV) SEA-CD40; Drug: Pembrolizumab |
| SC Monotherapy in Solid Tumors | Experimental | SEA-CD40 administered SC Receives: Drug: Subcutaneous (SC) SEA-CD40 |
| SC Monotherapy in Lymphomas | Experimental | SEA-CD40 administered SC Receives: Drug: Subcutaneous (SC) SEA-CD40 |
| Combination Therapy in Pancreatic Cancer | Experimental | SEA-CD40 (administered IV) + pembrolizumab + gemcitabine + nab-paclitaxel Receives: Drug: Intravenous (IV) SEA-CD40; Drug: Pembrolizumab; Drug: Gemcitabine; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (Parts A-K)
Measured: Through 6 weeks following last dose, up to an average of 6 months
Incidence of laboratory abnormalities (Parts A-K)
Measured: Through 6 weeks following last dose, up to an average of 6 months
Objective response rate (ORR) per RECIST according to investigator assessment in the efficacy-evaluable population (Part L)
Measured: Through 6 weeks following last dose, up to an average of 6 months
Secondary outcomes (15)
Incidence of adverse events (Part L)
Measured: Through 6 weeks following last dose, up to an average of 6 months
ORR per iRECIST (Part L)
Measured: Through 6 weeks following last dose, up to an average of 6 months
ORR (Parts A-K)
Measured: Through 6 weeks following last dose, up to an average of 6 months
Disease control rate (All Parts)
Measured: Through 6 weeks following last dose, up to an average of 6 months
Duration of response (All Parts)
Measured: Up to approximately 6 years
Progression-free survival (All Parts)
Measured: Up to approximately 6 years
Overall survival (All Parts)
Measured: Up to approximately 6 years
Cmax (maximum observed concentration)
Measured: Through 6 weeks following last dose, up to an average of 6 months
Tmax (time of maximum observed concentration)
Measured: Through 6 weeks following last dose, up to an average of 6 months
AUClast (AUC from time 0 to last quantifiable timepoint)
Measured: Through 6 weeks following last dose, up to an average of 6 months
AUCinf (AUC from time 0 to infinity)
Measured: Through 6 weeks following last dose, up to an average of 6 months
Apparent total clearance
Measured: Through 6 weeks following last dose, up to an average of 6 months
T1/2 (apparent terminal elimination half-life)
Measured: Through 6 weeks following last dose, up to an average of 6 months
Incidence of antitherapeutic antibodies against SEA-CD40
Measured: Through 6 weeks following last dose, up to an average of 6 months
Blood concentrations of SEA-CD40
Measured: Through 6 weeks following last dose, up to an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study start28 Feb 2015
- Primary completion6 Mar 2023
- Study completion14 Apr 2023
Why it stopped: Study closed due to portfolio prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Michael Schmitt, MD, PhD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376699
- Sponsor's protocol ID
- SGNS40-001
- Other IDs
- PN 863
- Status last verified
- Apr 2023
- First submitted
- 17 Feb 2015
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Coveler AL, Smith DC, Phillips T, Curti BD, Goel S, Mehta AN, Kuzel TM, Markovic SN, Rixe O, Bajor DL, Gajewski TF, Gutierrez M, Lee HJ, Gopal AK, Caimi P, Heath EI, Thompson JA, Ansari S, Jacquemont C, Topletz-Erickson A, Zhou P, Schmitt MW, Grilley-Olson JE. Phase 1 dose-escalation study of SEA-CD40: a non-fucosylated CD40 agonist, in advanced solid tumors and lymphomas. J Immunother Cancer. 2023 Jun;11(6):e005584. doi: 10.1136/jitc-2022-005584.
PubMed 37385724
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose-escalation Study of SEA-CD40 in Adult Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT02376699
- Acronym / sponsor ID
- SGNS40-001
- Conditions
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Hodgkin Disease, Lymphoma, Lymphoma, B-Cell, Lymphoma, Follicular
- Keywords
- CD40 Antigen, Drug Therapy, Follicular Lymphoma, Hodgkin Disease, Immunotherapy, Indolent Lymphoma, Lymphoma, Lymphoma, B-Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to portfolio prioritization
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 28 Feb 2015 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 3 Mar 2015 (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.
This study is being done to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.
Detailed description
The study will be conducted in the following parts:
Part A: Intravenous (IV) monotherapy dose-regimen finding for solid tumors -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the IV SEA-CD40 monotherapy maximum tolerated dose (MTD) and/or the optimal biological dose (OBD) regimens in patients with solid tumors. The ability to increase the dose intensity (to give additional doses within a treatment cycle) may be evaluated.
Part B: IV monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD and/or OBD determined in Part A.
Part C: IV monotherapy dose-regimen finding for lymphomas -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the IV SEA-CD40 monotherapy MTD and/or the OBD regimens in patients with lymphomas. The ability to increase the dose intensity (to give additional doses within a treatment cycle) may be evaluated.
Part D: IV monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD and/or OBD determined in Part C.
Part E: Combination therapy dose-regimen finding for solid tumors -- IV SEA-CD40 dose-escalation to define the MTD and/or the OBD regimen to be administered in combination with standard approved dose of pembrolizumab in patients with solid tumors.
Part F: Combination therapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with IV SEA-CD40 and pembrolizumab combination therapy; doses of SEA-CD40 will be at or below the MTD and/or OBD determined in Part E.
Part G: Subcutaneous (SC) injection (injected under the skin) monotherapy dose-regimen finding for solid tumors -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the SC SEA-CD40 monotherapy maximum tolerated dose (MTD) and/or the optimal biological dose (OBD) regimens in patients with solid tumors.
Part H: SC monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD and/or OBD determined in Part G.
(Note: There is no Part I)
Part J: SC monotherapy dose-regimen finding for lymphomas -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the SC SEA-CD40 monotherapy MTD and/or the OBD regimens in patients with lymphomas.
Part K: SC monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD and/or OBD determined in Part J.
Part L: Combination therapy in pancreatic cancer -- Patients will be treated with SEA-CD40 doses at or below MTD and/or OBD. An established dose of pembrolizumab and a standard regimen of gemcitabine and nab-paclitaxel will be used.
In Parts A, C, E, G, and J, a maximum feasible dose (MFD) will be defined if an MTD and/or OBD cannot be identified. Parts B, D, F, H, K. and L will explore the recommended dosing regimen once the MTD and/or OBD, or MFD (if the MTD and/or OBD cannot be identified) has been determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| IV Monotherapy in Solid Tumors | Experimental | Drug: Intravenous (IV) SEA-CD40SEA-CD40 administered IV |
| IV Monotherapy in Lymphomas | Experimental | Drug: Intravenous (IV) SEA-CD40SEA-CD40 administered IV |
| Combination Therapy in Solid Tumors | Experimental | Drug: Intravenous (IV) SEA-CD40, Drug: PembrolizumabSEA-CD40 (administered IV) + pembrolizumab |
| SC Monotherapy in Solid Tumors | Experimental | Drug: Subcutaneous (SC) SEA-CD40SEA-CD40 administered SC |
| SC Monotherapy in Lymphomas | Experimental | Drug: Subcutaneous (SC) SEA-CD40SEA-CD40 administered SC |
| Combination Therapy in Pancreatic Cancer | Experimental | Drug: Intravenous (IV) SEA-CD40, Drug: Pembrolizumab, Drug: Gemcitabine, Drug: Nab-paclitaxelSEA-CD40 (administered IV) + pembrolizumab + gemcitabine + nab-paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- (Monotherapy - Parts A, B, C, D, G, H, J, and K) -- Histologically confirmed advanced malignancy, either: (a) Metastatic or unresectable solid malignancy; or (b) Classical Hodgkin lymphoma (HL), or diffuse large B-cell lymphoma (DLBCL), or indolent lymphoma (including follicular lymphoma [FL])
- (Monotherapy - Parts A, B, C, D, G, H, J, and K) -- Relapsed, refractory, or progressive disease, specifically: (a) Solid tumors: Following at least 1 prior systemic therapy, and no further standard therapy is available for the patient's advanced solid tumor at the time of enrollment; or (b) Classical HL: Following at least 2 prior systemic therapies in patients who are not candidates for autologous stem cell transplant (SCT), or following failure of autologous SCT; or (c) DLBCL: Following at least 1 prior systemic therapy; patients must have also received intensive salvage therapy unless they refused or were deemed ineligible; or (d) Indolent lymphoma: Following at least 1 prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option exists
- (Combination Therapy - Part E and Part F) -- Histologically or cytologically confirmed advanced or metastatic solid malignancy for which pembrolizumab treatment is approved. In Part F, other advanced solid tumor indications may be eligible as identified by the Sponsor.
- (Pancreatic Cancer Cohort - Part L) - Histologically or cytologically confirmed metastatic exocrine ductal adenocarcinoma of the pancreas not amenable to curative therapy. Patients must not have received any prior systemic therapy for metastatic disease; patients who have received prior therapy for non-metastatic pancreatic adenocarcinoma are eligible if therapy was fully completed more than 4 months before start of study treatment.
- Representative baseline tumor tissue sample is available (Parts A-K)
Key exclusion criteria (20 listed)
- Parts A-K
- Part L
- All Parts
- Patients with lymphomas: prior allogeneic SCT
- Patients in Part E, F, or L: history of severe immune-mediated adverse reactions or severe hypersensitivity to pembrolizumab
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 |
|---|---|---|
| Intravenous (IV) SEA-CD40Also: SEA-CD40Given intravenously; schedule is cohort-specific. | Drug | Combination Therapy in Pancreatic Cancer, Combination Therapy in Solid Tumors, IV Monotherapy in Lymphomas, IV Monotherapy in Solid Tumors |
| PembrolizumabAlso: KeytrudaGiven intravenously; schedule is cohort-specific. | Drug | Combination Therapy in Pancreatic Cancer, Combination Therapy in Solid Tumors |
| Subcutaneous (SC) SEA-CD40Also: SEA-CD40Given subcutaneously on Day 1 every 3 weeks | Drug | SC Monotherapy in Lymphomas, SC Monotherapy in Solid Tumors |
| GemcitabineAlso: Gemzar1000 mg/m^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle | Drug | Combination Therapy in Pancreatic Cancer |
| Nab-paclitaxelAlso: Abraxane125 mg/m^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle | Drug | Combination Therapy in Pancreatic Cancer |
Primary outcome
Incidence of adverse events (Parts A-K)
Time frame: Through 6 weeks following last dose, up to an average of 6 months
Incidence of laboratory abnormalities (Parts A-K)
Time frame: Through 6 weeks following last dose, up to an average of 6 months
Objective response rate (ORR) per RECIST according to investigator assessment in the efficacy-evaluable population (Part L)
Time frame: Through 6 weeks following last dose, up to an average of 6 months
15 secondary outcomes
Incidence of adverse events (Part L)
Time frame: Through 6 weeks following last dose, up to an average of 6 months
ORR per iRECIST (Part L)
Time frame: Through 6 weeks following last dose, up to an average of 6 months
ORR (Parts A-K)
Time frame: Through 6 weeks following last dose, up to an average of 6 months
Disease control rate (All Parts)
Time frame: Through 6 weeks following last dose, up to an average of 6 months
Duration of response (All Parts)
Time frame: Up to approximately 6 years
Progression-free survival (All Parts)
Time frame: Up to approximately 6 years
Overall survival (All Parts)
Time frame: Up to approximately 6 years
Cmax (maximum observed concentration)
Time frame: Through 6 weeks following last dose, up to an average of 6 months
Tmax (time of maximum observed concentration)
Time frame: Through 6 weeks following last dose, up to an average of 6 months
AUClast (AUC from time 0 to last quantifiable timepoint)
Time frame: Through 6 weeks following last dose, up to an average of 6 months
AUCinf (AUC from time 0 to infinity)
Time frame: Through 6 weeks following last dose, up to an average of 6 months
Apparent total clearance
Time frame: Through 6 weeks following last dose, up to an average of 6 months
T1/2 (apparent terminal elimination half-life)
Time frame: Through 6 weeks following last dose, up to an average of 6 months
Incidence of antitherapeutic antibodies against SEA-CD40
Time frame: Through 6 weeks following last dose, up to an average of 6 months
Blood concentrations of SEA-CD40
Time frame: Through 6 weeks following last dose, up to an average of 6 months
Results and safety
The study was stopped early (reason given: Study closed due to portfolio prioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Derived from this study: PubMed 37385724Coveler AL, Smith DC, Phillips T, Curti BD, Goel S, Mehta AN, Kuzel TM, Markovic SN, Rixe O, Bajor DL, Gajewski TF, Gutierrez M, Lee HJ, Gopal AK, Caimi P, Heath EI, Thompson JA, Ansari S, Jacquemont C, Topletz-Erickson A, Zhou P, Schmitt MW, Grilley-Olson JE. Phase 1 dose-escalation study of SEA-CD40: a non-fucosylated CD40 agonist, in advanced solid tumors and lymphomas. J Immunother Cancer. 2023 Jun;11(6):e005584. doi: 10.1136/jitc-2022-005584.
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Michael Schmitt, MD, PhD study director
Seagen Inc.
19 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 Intravenous (IV) SEA-CD40, Pembrolizumab and Subcutaneous (SC) SEA-CD40 in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Squamous Cell, run by Seagen Inc. at 19 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?
The sponsor lists 9 inclusion and 20 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: stopped early, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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: Study closed due to portfolio prioritization). 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?
Incidence of adverse events (Parts A-K) (time frame: Through 6 weeks following last dose, up to an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02376699, which also lists 1 linked publication.
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 May 2023.