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 (FIT-001)

NCT06026410 Phase 1 RECRUITING

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.

Details

Lead sponsor	Kura Oncology, Inc.
Phase	Phase 1
Status	RECRUITING
Enrolment	300
Start date	2023-10-18
Completion	2027-04

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

• Darlifarnib
• Cabozantinib
• Adagrasib

Primary outcomes

• Rate of dose-limiting toxicities (DLTs) — DLTs will be evaluated during the first 28 days of KO-2806 treatment (dose escalation)
• Descriptive statistics of adverse events (AEs) — First dose of KO-2806 up to and including 28 days after last dose of KO-2806 (dose escalation)
  NCI-CTCAE v5.0
• Incidence of dose interruptions, reductions, and discontinuations due to AE — First dose of KO-2806 up to last dose of KO-2806 or up to 24 months of treatment (dose escalation)
• Objective Response Rate (ORR) — Up to an estimated period of 24 months (dose expansion)
  Assessed per RECIST v1.1

Countries

United States, France, Germany, Italy, Spain