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

Conditions

• KRAS-mutant Colorectal Cancer (CRC)
• KRAS-mutant Non-small Cell Lung Cancer (NSCLC)
• KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC)
• Other KRAS-mutant Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• KST-6051 — DRUG
  KST-6051 will be administered orally as a tablet.

Study Details

The main purpose of the trial is to assess whether the trial drug, KST-6051, is safe and tolerable when administered orally to adults with advanced or metastatic solid tumors with certain KRAS mutations.

Key Dates

Start date

Apr 21, 2026

Status verified

Mar 2026

Primary completion

Jun 30, 2027

Completion

May 31, 2028

Study Design

Enrollment

145 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: KST-6051 Dose Escalation
  Sequential cohorts with increasing doses of KST-6051 will be evaluated to determine recommended dose(s) for expansion (RDE\[s\]).

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days) [ Time Frame: Up to Day 21 of Treatment Cycle 1 ]

Central Contacts

• Kestrel Therapeutics, Inc.
  617-612-6810
  [email protected]

Locations (7)

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