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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

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Trial Profile

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 of Trial: Phase I

Latest Information Update: 19 Jun 2025

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At a glance

  • Drugs Adagrasib (Primary) ; Cabozantinib (Primary) ; KO-2806 (Primary)
  • Indications Adenocarcinoma; Colorectal cancer; Ductal carcinoma; Head and neck cancer; Non-small cell lung cancer; Pancreatic cancer; Renal cell carcinoma; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms FIT-001
  • Sponsors Kura Oncology

Most Recent Events

  • 01 May 2025 According to Kura Oncology media release, Company to initiate one or more FIT-001 expansion cohorts of KO-2806 and cabozantinib in patients with advanced renal cell carcinoma in the second half of 2025. Company will present data from this study evaluating KO-2806 and cabozantinib and monotherapy in patients with renal cell carcinoma in the second half of 2025.
  • 05 Feb 2025 According to a Kura Oncology media release, KO-2806 monotherapy in HRAS-mutant and KRAS-mutated solid tumors and KO-2806 in combination with cabozantinib in renal cell carcinoma (RCC) data expected in 2H 2025.
  • 07 Nov 2024 According to a Kura Oncology media release, the company will initiate one or more expansion cohorts for the combination of KO-2806 and cabozantinib in renal cell carcinoma in the first half of 2025.

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