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

Recruiting now · Phase 1

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

In brief

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 facts

Study ID

NCT07458347

Run by

Kestrel Therapeutics, Inc.

People needed

145

Starts

2026-04-21

Expected to finish

2028-05-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Willing and able to give written informed consent.
• Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor.
• Documentation of KRAS mutation prior to the first dose of trial drug(s).
• Progressed on or intolerant to standard treatment(s).
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Adequate cardiovascular, hematological, liver, and renal function.
• Measurable disease at baseline per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).

You may not qualify if…

• Previous or current treatment with RAS or KRAS inhibitors.
• Central nervous system (CNS) tumors or metastases.
• Inability to swallow oral medications.
• Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
• Other inclusion/exclusion criteria are specified in the protocol.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Mass General Brigham Cancer Institute at Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Oncology — San Antonio, Texas, United States (enrolling)
• Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.