drugset / Trial / NCT04326296
The Safety and Tolerability of PD-L1 Monoclonal Antibody Plus Lenalidomide in The Treatment of Colorectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
This study proposed by increasing dosage and expand the "3 + 3" queue, main component is divided into two phases, phase 1 for dose escalation, according to preliminary data recommended doses starting dose of climbing, the purpose is to evaluate the safety of combination therapy, tolerance, and explore the maximum tolerated dose (MTD) and right dose recommended development stage;Phase 2 was the expansion phase. Patients were included in the expansion study according to the appropriate dose recommended in phase 1, to further evaluate the safety and tolerability of combination therapy, recommend appropriate dose for phase II clinical trial, and preliminarily explore the efficacy of combination therapy.
Timeline
- Start
- 2020-05-30
- Primary completion
- 2022-09
- Completion
- 2023-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Lenalidomide | Other / unclassified | 25 mg | Oral |