NCT07458347RecruitingPhase 1
A Phase 1 Dose Escalation and Dose Expansion Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation
A First-in-human Phase 1 Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KST-6051 in Patients With Advanced or Metastatic Solid Tumors With a KRAS Mutation
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 545 (estimated)
- First submitted
- 3 Mar 2026
- Start date
- 21 Apr 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Kestrel Therapeutics, Inc.
- Diseases
- Endometrial cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Sarcoma
- NCT number
- NCT07458347
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 545
- From 21 Apr 2026 to the primary completion date, 30 Apr 2028
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to swallow oral medications.
Other
- Central nervous system (CNS) tumors or untreated or unstable metastases.
- 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.
Who the study is looking for
- 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).
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mass General Brigham Cancer Institute at Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| NEXT Oncology Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.