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Also known as Anti-CD40 Agonist Monoclonal Antibody CDX-1140, Agonist CD40 Antibody CDX-1140, Anti-CD40 Agonistic Monoclonal Antibody CDX-1140
CDX-1140 · 3 trials · 29 indications
Number of participants with dose-limiting toxicities based on CTCAE v5.0
Number of participants with durable or persistent CD4+ Th1 responses to the melanoma vaccine at either day 85 or day 176, or both
Severity of adverse events using CTCAE version 5.0
The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.
| Arm | Type | Description |
|---|---|---|
| All Participants | EXPERIMENTAL | 6MHP (200mcg of each peptide) and 300mcg of NeoAg-mBRAF will be co-administered locally with 0.9mg of polyICLC and CDX-1140. There will be a dose escalation of CDX-1140 (50mcg, 200mcg, 800mcg, 3.0mg). A vaccine containing all of these components will be given on days 1, 22, 43, and 64. The vaccine will be given subcutaneously/intradermally. |
| CDX-1140 + TCR-T + Pembro | EXPERIMENTAL | Patients will receive CDX-1440, TCR-T, and pembrolizumab. |
| CDX-1140 | EXPERIMENTAL | Part 1: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance, or two years of treatment. |
| CDX-1140 and CDX-301 | EXPERIMENTAL | Part 2: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance or two years of treatment. A fixed dose of CDX-301 is injected once a day for five days before cycles 1 and 2 of CDX-1140. |
| CDX-1140 and pembrolizumab | EXPERIMENTAL | Part 3: Eligible patients will receive CDX-1140, based on cohort assigned, in 3 week cycles until progression, or intolerance, or two years of treatment. A fixed dose of pembrolizumab will also be given in 3 week cycles. |
| CDX-1140 and chemotherapy | EXPERIMENTAL | Part 4: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, or intolerance, or two years of treatment. Chemotherapy will also be given according to standard of care. |
| Name | Type | Description |
|---|---|---|
| 6MHP | DRUG | 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides |
| NeoAg-mBRAF | DRUG | BRAF 586-614 (V600E) peptide to which a histidine has been added to the N-terminus, resulting in BRAF 585-614 (V600E). |
| PolyICLC | DRUG | polyICLC, local adjuvant |
| CDX-1140 | DRUG | CDX-1140, local adjuvant |
| TCR-transduced T cells | BIOLOGICAL | TSA-reactive TCR-engineered T cells |
| Pembrolizumab | DRUG | Humanized immunoglobulin G4 (IgG4) monoclonal antibody |
| CDX-301 | DRUG | CDX-301 will be injected once a day for five days before Cycles 1 and 2. |
| Chemotherapy | DRUG | Gemcitabine and Nab-paclitaxel will be administered on Day 1, Day 8 and Day 15 of each 4 week Cycle. |
Main Inclusion Criteria: 1. a. For individuals with primary cutaneous, mucosal, or unknown melanoma, an individual must have stage IB ulcerated, II, III, or IV melanoma at original diagnosis or at restaging after recurrence, and be rendered clinically free of disease by surgery, other therapy, or s...
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CDX-1140 is an investigational cancer therapy being studied in adults with advanced solid tumors and certain lymphomas. Its studied indications include melanoma, non-small cell lung cancer, breast cancer, gastric cancer, renal cell carcinoma, ovarian cancer, and several B-cell lymphomas. It is also being evaluated in malignant epithelial neoplasms and ocular melanoma through combination vaccine research.
CDX-1140 targets CD40, a receptor on antigen-presenting cells that helps activate immune responses. It is a CD40 agonist small molecule designed to stimulate this pathway. By activating CD40 signaling, the drug aims to enhance immune-mediated recognition and attack of tumor cells.
CDX-1140 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded under the ticker CLDX. Celldex is the sponsor of the clinical trials evaluating CDX-1140 in advanced malignancies and melanoma.
CDX-1140 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 1 program includes completed and active studies evaluating the drug as monotherapy, in combination regimens, and in vaccine-based approaches.
CDX-1140 has been evaluated in three Phase 1 trials. NCT03329950 studied it as monotherapy or in combination in advanced malignancies with 132 patients enrolled. NCT04364230 tested a melanoma vaccine approach with CD40 activation in 22 patients. NCT05349890 is an active TCR-T study in malignant epithelial neoplasms.
CDX-1140 is also referred to as CDX-1140 (CD40), reflecting its molecular target. Both names refer to the same investigational CD40 agonist small molecule developed by Celldex Therapeutics for advanced solid tumors and lymphomas.