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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: 27 Mar 2026

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At a glance

  • Drugs Adagrasib (Primary) ; Cabozantinib (Primary) ; Darlifarnib (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

  • 12 Jan 2026 According to a Kura Oncology media release, preliminary data from darlifarnib and adagrasib in KRASG12C-mutated solid tumors (non-small cell lung cancer, colorectal cancer, pancreatic ductal adenocarcinoma) expected in the first half of 2026. updated dose-escalation data from darlifarnib and cabozantinib in advanced RCC (Phase 1a) in expected in the second half of 2026.
  • 02 Jan 2026 Protocol has been amended to include four new arms (Experimental: Arm 4, 5, 6 and 7) , it has changed from 3 to 7.
  • 04 Nov 2025 According to Kura Oncology media release, preliminary clinical data from the combination of darlifarnib and adagrasib in patients with KRASG12C-mutated solid tumor indications expected in 2026.

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