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

Gemcitabine/nab-paclitaxel

Cetuximab

Pembrolizumab

mFOLFOX6

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, alone or in combination with other anticancer agents, 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

Oct, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2028

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. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
6. Adequate cardiovascular, hematological, liver, and renal function.
7. Measurable disease at baseline per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).

Exclusion Criteria:

1. Central nervous system (CNS) tumors or untreated or unstable metastases.
2. Inability to swallow oral medications.
3. 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

545 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KST-6051 Dose Escalation Monotherapy

Sequential cohorts with increasing doses of KST-6051 as monotherapy will be evaluated to determine recommended dose(s) for expansion (RDE\[s\]).

experimental: KST-6051 Dose Escalation Combination Therapy with Gemcitabine/Nab-paclitaxel

Sequential cohorts with increasing doses of KST-6051 as combination therapy with a standard dose of gemcitabine/nab-paclitaxel will be evaluated in participants with previously treated PDAC.

experimental: KST-6051 Dose Escalation Combination Therapy with Cetuximab

Sequential cohorts with increasing doses of KST-6051 as combination therapy with a standard dose of cetuximab will be evaluated in participants with previously treated KRAS-mutant mCRC.

experimental: KST-6051 Dose Escalation Combination Therapy with Pembrolizumab

Sequential cohorts with increasing doses of KST-6051 as combination therapy with a standard dose of pembrolizumab will be evaluated in participants with first- or second-line KRAS-mutant NSCLC.

experimental: KST-6051 Dose Expansion Monotherapy in PDAC After 1 or 2 Prior Lines of Therapy

Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in PDAC after 1 or 2 prior lines of therapy.

experimental: KST-6051 Dose Expansion Monotherapy in mCRC After 1 or 2 prior Lines of Therapy

Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in mCRC after 1 or 2 prior lines of therapy.

experimental: KST-6051 Dose Expansion Monotherapy in NSCLC After 1 or 2 Prior Lines of Therapy

Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in NSCLC after 1 or 2 prior lines of therapy.

experimental: KST-6051 Dose Expansion Monotherapy in Prior RAS/KRAS Inhibitor-treated Solid Tumors

Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in prior RAS/KRAS inhibitor-treated solid tumors.

experimental: KST-6051 Dose Expansion Monotherapy in Later-line Settings

Dose expansion cohorts will be evaluated to further investigate KST-6051 as monotherapy in selected KRAS-mutant biliary tract cancer, endometrial cancer (EC), or other solid tumors in later-line settings.

experimental: KST-6051 Dose Expansion Combination Therapy with Gemcitabine/nab-paclitaxel

Dose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with gemcitabine/nab-paclitaxel in 1L PDAC.

experimental: KST-6051 Dose Expansion Combination Therapy with Cetuximab

Dose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with cetuximab in 2L/3L CRC.

experimental: KST-6051 Dose Expansion Combination Therapy with Cetuximab and mFOLFOX6 or FOLFIRI

Dose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with cetuximab and mFOLFOX6 or FOLFIRI in 1L CRC.

experimental: KST-6051 Dose Expansion Combination Therapy with Pembrolizumab and Pemetrexed/carboplatin

Dose expansion cohorts will be evaluated to further investigate KST-6051 as combination therapy with pembrolizumab and pemetrexed/carboplatin in 1L NSCLC.

Interventions

KST-6051

KST-6051 will be administered orally as a tablet.

Gemcitabine/nab-paclitaxel

Gemcitabine/nab-paclitaxel will be administered intravenously (IV).

Cetuximab

Cetuximab will be administered IV.

Pembrolizumab

Pembrolizumab will be administered IV.

mFOLFOX6

mFOLFOX6 will be administered IV.

FOLFIRI

FOLFIRI will be administered IV.

Pemetrexed

Pemetrexed will be administered IV.

Carboplatin

Carboplatin will be administered IV.

Primary outcome measure

  • Dose Escalation Cohorts: 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 ]
  • Dose Escalation Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 2 years ]
  • Dose Escalation Cohorts: Number of Participants With Treatment-related Adverse Events (TRAEs) [ Time Frame: Up to approximately 2 years ]
  • Dose Expansion Cohorts: Confirmed Objective Response Rate (ORR) [ 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

Oct 15, 2026

Last verified

Oct, 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
  • Post-RAS targeted therapies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Kestrel Therapeutics, Inc. on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.