Study Stopped
Study closed due to portfolio prioritization
Safety Study of SEA-CD40 in Cancer Patients
A Phase 1, Open-label, Dose-escalation Study of SEA-CD40 in Adult Patients With Advanced Malignancies
2 other identifiers
interventional
159
1 country
19
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2015
Longer than P75 for phase_1
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2015
CompletedStudy Start
First participant enrolled
February 28, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2023
CompletedMay 1, 2023
April 1, 2023
8 years
February 17, 2015
April 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of adverse events (Parts A-K)
Through 6 weeks following last dose, up to an average of 6 months
Incidence of laboratory abnormalities (Parts A-K)
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)
Through 6 weeks following last dose, up to an average of 6 months
Secondary Outcomes (15)
Incidence of adverse events (Part L)
Through 6 weeks following last dose, up to an average of 6 months
ORR per iRECIST (Part L)
Through 6 weeks following last dose, up to an average of 6 months
ORR (Parts A-K)
Through 6 weeks following last dose, up to an average of 6 months
Disease control rate (All Parts)
Through 6 weeks following last dose, up to an average of 6 months
Duration of response (All Parts)
Up to approximately 6 years
- +10 more secondary outcomes
Study Arms (6)
IV Monotherapy in Solid Tumors
EXPERIMENTALSEA-CD40 administered IV
IV Monotherapy in Lymphomas
EXPERIMENTALSEA-CD40 administered IV
Combination Therapy in Solid Tumors
EXPERIMENTALSEA-CD40 (administered IV) + pembrolizumab
SC Monotherapy in Solid Tumors
EXPERIMENTALSEA-CD40 administered SC
SC Monotherapy in Lymphomas
EXPERIMENTALSEA-CD40 administered SC
Combination Therapy in Pancreatic Cancer
EXPERIMENTALSEA-CD40 (administered IV) + pembrolizumab + gemcitabine + nab-paclitaxel
Interventions
Given intravenously; schedule is cohort-specific.
Given intravenously; schedule is cohort-specific.
Given subcutaneously on Day 1 every 3 weeks
1000 mg/m\^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle
125 mg/m\^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle
Eligibility Criteria
You may qualify if:
- (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
- 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
You may not qualify if:
- 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)
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (19)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, 85258, United States
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048, United States
Angeles Clinic and Research Institute, The
Santa Monica, California, 90404, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637-1470, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4095, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109-1023, United States
Related Publications (1)
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.
PMID: 37385724DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Schmitt, MD, PhD
Seagen Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2015
First Posted
March 3, 2015
Study Start
February 28, 2015
Primary Completion
March 6, 2023
Study Completion
April 14, 2023
Last Updated
May 1, 2023
Record last verified: 2023-04