Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP1503 · 1 trial · 7 indications
Number of participants with EPD1503 related adverse events as assessed per CTCAE v5.0
Safety and tolerability of EDP1503 alone and in combination with pembrolizumab assessed via clinical laboratory evaluations
To determine preliminary evidence of anti-tumor activity of EDP1503 in patients
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Cohort A includes patients with microsatellite stable (MSS) colorectal cancer (CRC). Patients will receive a 14 day run-in of EDP1503 alone, following which they will be treated with a combination of EDP1503 and pembrolizumab. |
| Cohort B | EXPERIMENTAL | Cohort B includes patients with Triple Negative Breast Cancer (TNBC). Patients will receive a 14 day run-in of EDP1503 alone, following which they will be treated with a combination of EDP1503 and pembrolizumab. |
| Cohort C | EXPERIMENTAL | Cohort C includes patients with non-small-cell lung cancer (NSCLC), bladder cancer; gastroesophageal (GE) cancer, any microsatellite unstable, or renal cell carcinoma (RCC) who are relapsed to prior PD-1/L1 therapy. Patients will receive a 14 day run-in of EDP1503 alone, following which they will be treated with a combination of EDP1503 and pembrolizumab. |
| Name | Type | Description |
|---|---|---|
| EDP1503 | BIOLOGICAL | 4 capsules taken by mouth twice daily. Each capsule will contain ≥ 7.5x10\^10 colony-forming units (CFU) |
| Pembrolizumab | BIOLOGICAL | 200 mg given by intravenous (IV) infusion once every 3 weeks |
Selected Inclusion Criteria: 1. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors who have had disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment,...
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