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 · NCT07458347 · Interventional (participants receive a specific treatment) · Lead sponsor: Kestrel Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
KST-6051
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
- ther inclusion/exclusion criteria are specified in the protocol.
Where it is running
9 locations listed across 7 US states.
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- Florida Cancer Specialists - Sarasota, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Mass General Brigham Cancer Institute at Massachusetts General Hospital - Boston, Massachusetts, United States
- Sidney Kimmel Cancer Center - Philadelphia, Pennsylvania, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- NEXT Oncology - San Antonio, Texas, United States
- Huntsman Cancer Institute, University of Utah - Salt Lake City, Utah, United States
- NEXT Virginia - Fairfax, Virginia, United States