drugset / Trial / NCT04130854
INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer
Phase 2
Completed
58 enrolled
University of Texas Southwestern Medical Center
Apexigen America, Inc. · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Determine the complete pathologic complete response (pCR) rate in patients with locally advanced rectal adenocarcinoma.
Timeline
- Start
- 2020-04-24
- Primary completion
- 2026-01-30
- Completion
- 2026-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sotigalimab | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Other |