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NCT07458347 | RECRUITING | KRAS-mutant Non-small Cell Lung Cancer (NSCLC)

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

Kestrel Therapeutics, Inc.

Brief 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.

Condition or disease

KRAS-mutant Non-small Cell Lung Cancer (NSCLC)

KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC)

KRAS-mutant Colorectal Cancer (CRC)

Other KRAS-mutant Solid Tumors

Intervention/treatment

KST-6051

Phase

PHASE1

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 145 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A First-in-human Phase 1 Dose-escalation Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KST-6051 in Patients With Advanced or Metastatic Solid Tumors With a KRAS Mutation
Actual Study Start Date : 2026-04
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2028-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Age ≥ 18 years.
  • 2. Willing and able to give written informed consent.
  • 3. Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor.
  • 4. Documentation of KRAS mutation prior to the first dose of trial drug(s).
  • 5. Progressed on or intolerant to standard treatment(s).
  • 6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  • 7. Adequate cardiovascular, hematological, liver, and renal function.
  • 8. Measurable disease at baseline per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1).
Exclusion Criteria
  • 1. Previous or current treatment with RAS or KRAS inhibitors.
  • 2. Central nervous system (CNS) tumors or metastases.
  • 3. Inability to swallow oral medications.
  • 4. 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.
A Phase 1 Dose-escalation Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation

Location Details

NCT07458347

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Locations

RECRUITING

United States, Texas

NEXT Oncology

Saint Anthony, Texas, United States, 78229

RECRUITING

United States, Virginia

NEXT Virginia

Fairfax, Virginia, United States, 22031