RecruitingPhase 1

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

United States145 participantsStarted 2026-04-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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.

What they're measuring

Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days)

Timeframe: Up to Day 21 of Treatment Cycle 1

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to approximately 2 years

Number of Participants With Treatment-related Adverse Events (TRAEs)

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT07458347

SponsorKestrel Therapeutics, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Kestrel Therapeutics, Inc.

617-612-6810 clinicaltrials@kestreltherapeutics.com

View on ClinicalTrials.gov More KRAS-mutant Non-small Cell Lung Cancer (NSCLC) trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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.

What they're measuring

Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days)

Timeframe: Up to Day 21 of Treatment Cycle 1

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to approximately 2 years

Number of Participants With Treatment-related Adverse Events (TRAEs)

Timeframe: Up to approximately 2 years