A Phase 1 Dose Escalation and Dose Expansion Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 9 months later Jun 2027 → Apr 2028
Primary endpoint added 3 → 4 primary endpoints
See other at-risk trials from Kestrel Therapeutics, Inc.

Record History

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  1. Primary completion pushed from Jun 2027 to Apr 2028 Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 145 → 545 participants
    • Study completion pushed from May 2028 to Apr 2029
    • Interventions modified
    • Trial arms changed: 1 → 13
    • Secondary endpoints: 9 to 19
    • Study description expanded, about 21 words
    • Eligibility criteria shortened, about 3 words
    • Study title expanded, about 4 words
  2. Study sites: 8 to 9v10
  3. Study sites: 7 to 8v9
  4. Study sites: 6 to 7v8
  5. Study sites: 5 to 6v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date changed from estimate of Apr 2026 to Apr 21, 2026v6
  2. Study sites: 4 to 5v5
  3. Study sites: 3 to 4v4
  4. Study sites: 2 to 3v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints revised (3)
    • Study sites: 0 to 2
    v2
  1. Study First Submitted
  • 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.
Kestrel Therapeutics, Inc.
1 trial monitored
See 1 trial at risk
Lung Cancer
4,798 trials monitored
See 270 trials at risk
Colorectal Cancer
3,405 trials monitored
See 162 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,085 trials monitored
See 178 trials at risk
and 3 more diseases
The main purpose of the trial is to assess whether the trial drug, KST-6051, is safe and tolerable when administered orally, alone or in combination with other anticancer agents, to adults with advanced or metastatic solid tumors with certain KRAS mutations.
Trial Details
NCT Number NCT07458347
Lead Sponsor Kestrel Therapeutics, Inc.
Conditions
(from sponsor)		 KRAS-mutant Non-small Cell Lung Cancer (NSCLC), KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC), KRAS-mutant Colorectal Cancer (CRC), Other KRAS-mutant Solid Tumors
Related terms Biliary Tract Neoplasms, Cholangiocarcinoma, Colonic Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Lung Neoplasms, Neoplasm Metastasis, Pancreatic Neoplasms, Rectal Neoplasms
Enrollment 545 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov