Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC)

• Status: Not yet recruiting
• Trial end date: 2024-07-20
• Target enrollment: 0
• Participant gender: All

Summary

The study consists of the two parts, phase IIa and phase IIb.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Kechow Pharma, Inc.
• Treatments: Vemurafenib

Criteria

Inclusion Criteria:

• Signed written informed consent prior to enrollment；

• Adults 18 years of age or older, male or female;

• Histologically- or cytologically-confirmed CRC that is metastatic disease, and a) progression of disease or intolerance after line 1 or line 2 therapy，or inappropriate for line 1 therapy (for phase Ⅱa); b) progression of disease or intolerance after line 1 or line 2 therapy (for phase Ⅱb);

• Patient must have measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1);

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

• Life expectancy ≥ 3 months;

• Able to take the medicine orally;

• Adequate bone marrow and organ function.

Exclusion Criteria:

• Prior treatment with any RAS inhibitors, RAF inhibitors, or MEK inhibitors;

• History or screening evidence of retinal diseases;

• Impaired cardiovascular function or clinically significant cardiovascular and cerebrovascular diseases;

• Previous or current neuromuscular diseases that is associated with CK elevation (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolysis syndrome);

• Impaired liver function, defined as Child-Pugh Class B or C;

• Toxicity has not recovered to grade 0 or 1 from prior anticancer therapy (except for alopecia, pigmentation, and grade 2 chemotherapy-related neurotoxicity);

• Use of any medications or foods that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4/5 within 7 days prior to the start of study treatment or during the study period, , drugs with a narrow therapeutic window for CYP1A2 metabolism.