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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05187182 | CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer | PHASE1 | RECRUITING | 42 | — | — | Jun 2, 2023 | Apr 30, 2029 | Apr 27, 2026 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Dose Escalation (CA4948 + FOLFOX + Nivolumab) | EXPERIMENTAL | * CA4948 (dose will depend on dose level assigned) twice daily by mouth. Standard of care mFOLFOX7 every 14 days. Nivolumab every 14 days. * Each cycle is 14 days. |
| Dose Expansion Cohort A (CA4948 + FOLFOX + Nivolumab) | EXPERIMENTAL | * CA4948 (dose will be the recommended phase II dose found in the dose escalation portion of study) twice daily by mouth. Standard of care mFOLFOX7 every 14 days. Nivolumab every 14 days. * Each cycle is 14 days. |
| Dose Expansion Cohort B (CA4948 + FOLFOX + Pembrolizumab + Trastuzumab) | EXPERIMENTAL | * CA4948 (dose will be the recommended dose found in the dose escalation portion of study) twice daily by mouth Standard of care mFOLFOX7 every 14 days. Pembrolizumab on day 1 of every 3 cycles. Trastuzumab every 14 days. * Each cycle is 14 days. |
| Name | Type | Description |
|---|---|---|
| CA-4948 | DRUG | Provided by Curis, Inc. |
| Nivolumab | BIOLOGICAL | 240 mg IV on Day 1 of each cycle |
| Pembrolizumab | BIOLOGICAL | 400 mg IV on Day 1 of every 3 cycles (C1D1, C4D1, C7D1,…) and dosing may continue for a max of 2 years |
| Trastuzumab | DRUG | 6 mg/kg IV loading dose on Cycle 1 Day 1 and 4 mg/kg IV on Day 1 of every subsequent cycle |
| mFOLFOX7 | DRUG | Standard of care |
Inclusion Criteria: * Advanced unresectable or metastatic histologically or cytologically confirmed adenocarcinoma or squamous cell carcinoma of the stomach, gastroesophageal junction, or esophagus * Measurable or evaluable disease defined by RECIST 1.1. * Lesions amenable to research biopsy. This ...