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A Phase 1 Dose-escalation Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation
Trial Status: active
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.
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. Other inclusion/exclusion criteria are specified in the protocol.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07458347.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available
Pennsylvania
Philadelphia
Thomas Jefferson University Hospital
Status: Approved
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Approved
Name Not Available
This is a first-in-human, phase 1, open-label, multicenter clinical trial designed to
evaluate safety, tolerability, pharmacokinetics, biomarkers, pharmacodynamics and
preliminary activity of orally administered KST-6051. The trial seeks to enroll adults
with advanced or metastatic KRAS mutant solid tumors including but not limited to
pancreatic ductal adenocarcinoma, colorectal cancer, and non-small cell lung cancer whose
cancers have progressed after prior therapy or in whom standard therapy was not
tolerated. The trial includes a dose escalation phase in which higher doses of KST-6051
will be given in subsequent groups of participants. Participants can stay in the trial as
long as they benefit from the treatment and can tolerate it.
