Phase 2
Completed N=10
CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab
Source: ClinicalTrials.gov NCT03123783 ↗Enrolled (actual)
10
Serious AEs
36.6%
Results posted
Dec 2023
Primary outcomePrimary: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) — 0 Participants
Summary
This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. The Phase 1 portion is intended to establish the maximum tolerated dose and the recommended phase 2 dose of APX005M when administered in combination with nivolumab. The Phase 2 portion of the study will evaluate safety and efficacy of the combination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Dose-limiting Toxicities (DLTs) |
— | — |
| PRIMARY Maximum Tolerated Dose (MTD) of APX005M + Nivolumab (Phase 1b) |
NA | — |
| PRIMARY Phase 2 Evaluate the Objective Response Rate (ORR) by RECIST 1.1 and iRECIST in Each Cohort / Group |
16.67; 15.15; 0.00; 0.00 | — |
| SECONDARY Safety of the APX005M and Nivolumab Combination (Phase 2) |
52; 36; 14; 28 | — |
| SECONDARY Duration of Response (DOR) as Per RECIST 1.1(Phase 2) |
NA; NA | — |
| SECONDARY Median Progression-free Survival (PFS) (Phase 2) |
4.11; 1.97; 3.43; 3.65 | — |
| SECONDARY 6-month PFS Rate (Phase 2) |
33.10; 21.21; 25.00; 12.92 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed, immunotherapy naïve or PD-1/PD-L1 pre-treated, metastatic or locally advanced non-small cell lung cancer not amenable to curative treatment. Subjects may be treatment naive or could have received one prior platinum based chemotherapy for non-small cell lung cancer and subjects with a documented activating mutation (e.g., EGFR, ALK, ROS) must also have received the appropriate therapy and progressed
- Histologically or cytologically confirmed unresectable or metastatic melanoma that progressed during treatment with an anti-PD-1/PD-L1 therapy and had confirmation of PD>=4 weeks later. Subjects with BRAF activating mutation could have also received a BRAF inhibitor and/or MEK inhibitor regimen prior to anti-PD-1/PD-L1 therapy.
- Measurable disease by RECIST 1.1
- ECOG performance status of 0 or 1
- Adequate bone marrow, liver and kidney function
- Negative pregnancy test for women of child bearing potential
- Agreement to use effective methods of contraception per the protocol requirements
Exclusion Criteria
- Previous exposure to any immunomodulatory agents (e.g., anti- CD40, anti-PD-1/PD-L1, anti-CTLA-4, IDO inhibitors) except PD-1/PD-L1 targeting agents in the subsets of patients that must have previous treatment with anti-PD-1/PD-L1 therapy
- Second malignancy (solid or hematologic) within the past 3 years except locally curable cancers that have been apparently cured
- Active, known, clinically serious infections within the 14 days prior to first dose of investigational product
- Use of systemic corticosteroids or other systemic immunosuppressive drugs
- Active, known or suspected autoimmune disease
- History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis
- History of interstitial lung disease
- History of life-threatening toxicity related to prior anti-PD-1/PD-L1 treatment for subjects with metastatic melanoma or NSCLC.
Data sourced from ClinicalTrials.gov (NCT03123783). 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.