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KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

Study acronym: FIT-001
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 40 to 38v14
  2. Trial sites expanded: 37 → 40 locations Trial sites expanded: 32 → 37 locationsv13 Show 1 more changeShow less
    • Trial sites expanded: 32 → 37 locations
  3. Study sites: 32 to 37v12
  4. Primary endpoints: 3 to 4 Enrollment target: 270 to 300 · Eligibility criteria expanded, about 163 words · Secondary endpoints: 20 to 21 · 1 morev11 Show 4 more changesShow less
    • Enrollment target: 270 to 300
    • Eligibility criteria expanded, about 163 words
    • Secondary endpoints: 20 to 21
    • Study arms: 3 to 7

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 30 to 32 Interventions: Adagrasib (Drug), Cabozantinib (Drug), KO-2806 (Drug) to Adagrasib (Drug), Cabozantinib (Drug), Darlifarnib (Drug)v10 Show 1 more changeShow less
    • Interventions: Adagrasib (Drug), Cabozantinib (Drug), KO-2806 (Drug) to Adagrasib (Drug), Cabozantinib (Drug), Darlifarnib (Drug)
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 26 to 30 Eligibility criteria expanded, about 29 wordsv9 Show 1 more changeShow less
    • Eligibility criteria expanded, about 29 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 14 to 26v8
  3. Study sites: 13 to 14v7
  4. Study sites: 12 to 13v6
  5. Study sites: 10 to 12 Secondary endpoints: details revised at 2 of 20 entries · Eligibility criteria shortened, about 2 wordsv5 Show 2 more changesShow less
    • Secondary endpoints: details revised at 2 of 20 entries
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 4 to 10 Interventions: Cabozantinib (Drug), KO-2806 (Drug) to Adagrasib (Drug), Cabozantinib (Drug), KO-2806 (Drug) · Eligibility criteria expanded, about 26 words · Secondary endpoints: 21 to 20 · 2 morev4 Show 5 more changesShow less
    • Interventions: Cabozantinib (Drug), KO-2806 (Drug) to Adagrasib (Drug), Cabozantinib (Drug), KO-2806 (Drug)
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: 21 to 20
    • Study arms: 2 to 3
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 3 to 4 Start date changed from estimate of Oct 2023 to Oct 18, 2023v3 Show 1 more changeShow less
    • Start date changed from estimate of Oct 2023 to Oct 18, 2023
  8. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date: Sep 2023 to Oct 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date: Sep 2023 to Oct 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Kura Oncology, Inc.
7 trials monitored
See 1 trial at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
and 2 more diseases
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.
Trial Details
NCT Number NCT06026410
Lead Sponsor Kura Oncology, Inc.
Collaborators: Mirati Therapeutics Inc.
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)
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov