Recruiting
Phase 1

KST-6051

Sponsor:

Kestrel Therapeutics, Inc.

Code:

NCT07458347

Conditions

KRAS-mutant Non-small Cell Lung Cancer (NSCLC)

KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC)

KRAS-mutant Colorectal Cancer (CRC)

Other KRAS-mutant Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KST-6051

Study Details

Brief summary:

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.

Conditions

KRAS-mutant Non-small Cell Lung Cancer (NSCLC)

KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC)

KRAS-mutant Colorectal Cancer (CRC)

Other KRAS-mutant Solid Tumors

Study ID

NCT07458347

Start date

Apr 21, 2026

Status verified date

Mar, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Previous or current treatment with RAS or KRAS inhibitors.
2. Central nervous system (CNS) tumors or metastases.
3. Inability to swallow oral medications.
4. 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.

Study Design

Enrollment

145 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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\[s\]).

Interventions

KST-6051

KST-6051 will be administered orally as a tablet.

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 ]
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 2 years ]
  • Number of Participants With Treatment-related Adverse Events (TRAEs) [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Kestrel Therapeutics, Inc.

617-612-6810clinicaltrials@kestreltherapeutics.com

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Mass General Brigham Cancer Institute at Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Sidney Kimmel Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Huntsman Cancer Institute, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Kestrel Therapeutics, Inc.

Last update posted

Jun 29, 2026

Last verified

Mar, 2026

Keywords

  • Advanced Solid Tumors
  • Metastatic Solid Tumors
  • KRAS Mutation
  • KST-6051
  • KRAS
  • Lung Cancer
  • Pancreatic Cancer
  • Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer
  • Endometrial Cancer
  • Cholangiocarcinoma
  • Metastatic Cancer
  • Pan KRAS
  • Biliary Tract Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kestrel Therapeutics, Inc. on 2026-06-29.