Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03329950 | A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies | PHASE1 | COMPLETED | 132 | — | — | Dec 1, 2017 | Sep 13, 2022 | Mar 28, 2024 | 11 | United States |
The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| CDX-1140 | DRUG | CDX-1140 will be administered every 4 weeks in Parts 1, 2 and 4, and every 3 weeks in Part 3. |
| CDX-301 | DRUG | CDX-301 will be injected once a day for five days before Cycles 1 and 2. |
| pembrolizumab | DRUG | pembrolizumab will be administered every 3 weeks. |
| Chemotherapy | DRUG | Gemcitabine and Nab-paclitaxel will be administered on Day 1, Day 8 and Day 15 of each 4 week Cycle. |
Key Inclusion Criteria: 1. Recurrent, locally advanced or metastatic melanoma (including mucosal and/or ocular), bladder/urothelial, non-small cell lung cancer, pancreatic adenocarcinoma, breast, colorectal, gastric, esophageal, renal cell, hepatic, ovarian fallopian or primary peritoneal carcinoma...