NCT06026410

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of KO-2806 When Administered as Monotherapy and in Combination Therapy in Adult Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Kura Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Solid Tumors With HRAS Alterations
• Non Small Cell Lung Cancer (NSCLC)
• Colorectal Cancer (CRC)
• Pancreatic Ductal Adenocarcinoma (PDAC)
• Clear Cell Renal Cell Carcinoma (ccRCC)
• Renal Cell Carcinoma (Kidney Cancer)
• Non Clear Cell Renal Cell Carcinoma (nccRCC)

Interventions

Type	Name	Description
DRUG	Darlifarnib	Oral administration
DRUG	Cabozantinib	Oral administration
DRUG	Adagrasib	Oral administration

Timeline

• Start date: 2023-10-18
• Primary completion: 2027-01-01
• Completion: 2027-04-01
• First posted: 2023-09-07
• Last updated: 2026-04-14

Locations

40 sites across 5 countries: United States, France, Germany, Italy, Spain

Regulatory

• FDA-regulated drug study