What is the purpose of this study?
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.
Eligibility
- 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).
- Central nervous system (CNS) tumors or untreated or unstable 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.
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
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
- Age GroupAdult, Older Adult
- PhaseI
- IRB NumberSTUDY00004948
- ClinicalTrials.gov IDNCT07458347
- Key Eligibilityclinicaltrials.gov
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