Phase 2
Completed N=77
A Study of SEA-CD40 Given With Other Drugs in Cancers
Source: ClinicalTrials.gov NCT04993677 ↗Enrolled (actual)
77
Serious AEs
24.7%
Results posted
Jan 2025
Primary outcomePrimary: Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator Assessment — 0; 5; 44; 25 Percentage of participants
Summary
This trial is being done to see if an experimental drug (SEA-CD40) works when it's given with other cancer drugs to treat some types of cancer. It will also study side effects from the drug.
There are 2 parts in this trial. In one part, participants have melanoma that has come back after treatment or can't be removed by surgery. Participants in this part will get SEA-CD40 and pembrolizumab. In the other part, participants have non-small cell lung cancer (NSCLC) that has spread through their body. These participants will get SEA-CD40, pembrolizumab, carboplatin, and pemetrexed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator Assessment |
0; 5; 44; 25 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE |
17; 37; 8; 8; 16; 32 | — |
| SECONDARY Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE |
2; 7; 3; 3; 0; 3 | — |
| SECONDARY Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE |
7; 11; 4; 2; 0; 0 | — |
| SECONDARY Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events |
1; 5; 2; 1; 0; 0 | — |
| SECONDARY Disease Control Rate (DCR) Per Investigator Assessment |
48; 62; 67; 88 | — |
| SECONDARY Duration of Response (DOR) Per Investigator Assessment |
NA; 11.1; 2.1 | — |
| SECONDARY Progression Free Survival (PFS) Per Investigator Assessment |
1.6; 4.0; 13.8; 5.5 | — |
| SECONDARY Overall Survival (OS) |
11.0; NA; 18.0; NA | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed unresectable malignancy defined as one of the following:
- Cohort 1: Relapsed and/or refractory metastatic melanoma
- Uveal/ocular melanoma is excluded
- Must have progressed on treatment with an anti-PD-(L)1 mAb. PD-(L)1 treatment progression is defined as meeting all of the following criteria:
- Has received at least 2 doses of an approved anti-PD-(L)1 mAb
- Has demonstrated disease progression after PD-(L)1 as defined by RECIST v1.1.
- Progressive disease has been documented within 12 weeks from the last dose of anti- PD-(L)1 mAb
- Last dose of anti-PD-(L)1 must have been within 90 days prior to enrollment
- Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or declined treatment with BRAF/MEK targeted therapy prior to study entry
- Cohort 2: Metastatic uveal melanoma
- Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy
- No prior liver-directed therapy
- Cohort 3: Metastatic PD-(L)1-naive melanoma
- Uveal/ocular melanoma is excluded
- Must not have received prior treatment for advanced or metastatic disease except for prior adjuvant/neoadjuvant immunotherapy.
- For participants with a targetable BRAF mutation, prior BRAF/MEK targeted therapy is allowed if completed 4 weeks prior to first dose of study treatment.
- Cohorts 4 and 5: Non-squamous NSCLC
- Participants must have stage IV disease per AJCC 8th edition
- No known driver mutations/alterations mutation for which targeted therapy is available
- Must have non-squamous histology.
- No prior therapy for metastatic disease
- No prior treatment with anti-PD-(L)1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms
- Able to provide archival tumor tissue from locations not radiated prior to biopsy. If archival tumor sample is not available a fresh baseline biopsy is required.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Measurable disease per RECIST v1.1 at baseline
Exclusion Criteria
- History of another malignancy within 3 years of first dose of study drug
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Previous exposure to CD40-targeted therapy
- Currently on chronic systemic steroids in excess of physiologic replacement
- Has had an allogeneic tissue/solid organ transplant.
- History of autoimmune disease that has required systemic treatment in the past 2 years
Data sourced from ClinicalTrials.gov (NCT04993677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.