KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2027-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyl transferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.

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

Details

• Lead Sponsor: Kura Oncology, Inc.
• Collaborator: Mirati Therapeutics Inc.
• Treatments: Adagrasib

Criteria

Inclusion Criteria:

• At least 18 years of age.

• Histologically or cytologically confirmed advanced solid tumors

• Arm #1 (Monotherapy): HRAS-mutant and/or amplified tumors (any solid tumor type); HRAS overexpression (only for HNSCC tumors); KRAS and/or NRAS, and/or HRAS-mutant and/or amplified NSCLC or CRC; KRAS-mutant and/or amplified PDAC

• Arm #2 (Combination): Must have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC with predominantly clear cell subtype

• Arm #3 (Combination): Must have KRAS G12C-mutant locally advanced or metastatic NSCLC and have received at least 1 prior systemic therapy for advanced or metastatic NSCLC

• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

• Karnofsky Performance Status of 70 or higher with no clinically significant deterioration over the previous 2 weeks.

• Acceptable liver, renal, endocrine, and hematologic function.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Ongoing treatment with certain anticancer agents.

• Prior treatment with an FTI or HRAS inhibitor.

• Major surgery, other than local procedures, within 28 days prior to Cycle 1 Day 1, without complete recovery.

• Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.

• Toxicity (excluding alopecia) from prior therapy that has not been completely resolved to baseline at the time of consent.

• Active or prior documented autoimmune or inflammatory disorders within the past 5 years prior to Cycle 1 Day 1 (with exceptions).

• Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.

• Inability to swallow, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs.

• Inadequate cardiac and/or vascular function, including receipt of treatment for unstable angina, myocardial infarction, and/or cerebro-vascular attack within the prior 6 months, mean QTcF ≥470 ms, or Class II or greater congestive heart failure.

• Other invasive malignancy within 2 years.

• Other protocol-defined exclusion criteria may apply.