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A Phase 1a/1b, First-in-human, Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC
Details
| Lead sponsor | Rgenta Therapeutics Inc |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 105 |
| Start date | 2024-08-19 |
| Completion | 2027-06 |
Conditions
- Adenoid Cystic Carcinoma
- Colorectal Cancer
Interventions
- RGT-61159
Primary outcomes
- Number and type of dose-limiting toxicities (DLTs) in first cycle of administration — 21 days
- Number and type of adverse events — Through study completion, estimated as 30 days after last dose of study drug
- Recommended Phase 2 Dose (RP2D) — Assessed at the end of Cycle 1 for each subject (each cycle 21 days)
Countries
United States, Canada