A Study to Evaluate KIN-2787 in Subjects With BRAF Mutation Positive Solid Tumors

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF-mutated advanced or metastatic solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kinnate Biopharma

Criteria

Inclusion Criteria:

• Provide written informed consent prior to initiation of any study-specific procedures.

• Metastatic or advanced stage solid tumor.

• Known BRAF Class I, Class II, or Class III alteration as confirmed by previous genomic analysis of tumor tissue or ctDNA.

• Must have received prior standard therapy appropriate for the tumor type and stage of disease (including prior therapy with a BRAF inhibitor if FDA approved for the cancer type), OR unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.

• Measurable or evaluable disease by RECIST v1.1.

• ECOG performance status 0, 1, or 2.

• Adequate organ function, as measured by laboratory values (criteria listed in protocol).

• Able to swallow, retain, and absorb oral medications.

Exclusion Criteria:

• Known active brain metastases from non-brain tumors.

• For tumor types and indications not approved by FDA, prior receipt of any BRAF-, MEK-, or MAPK-directed inhibitor therapy.

• GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory GI disease.

• Seropositive for hepatitis B or hepatitis C.

• Women who are lactating or breastfeeding, or pregnant.

• In Dose Expansion, patients with BRAF Class I mutations are excluded.

Complete inclusion and exclusion criteria are listed in the clinical study protocol.