drugset / Trial / NCT03526835
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC. The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC). The study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.
Timeline
- Start
- 2018-05-02
- Primary completion
- 2025-11
- Completion
- 2027-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Petosemtamab | Monoclonal antibody | 1100 mg | Intravenous |
| Background | Petosemtamab | Monoclonal antibody | 1500 mg | Intravenous |
| Background | Irinotecan | Small molecule | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | Pembrolizumab | Monoclonal antibody | — | — |
| Background | Petosemtamab | Monoclonal antibody | — | — |
| Background | fluorouracil | Small molecule | — | — |