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NCT Number: NCT07458347

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

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.

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Key information

Conditions

KRAS-mutant Non-small Cell Lung Cancer (NSCLC) Adenocarcinoma Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Cholangiocarcinoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Intestinal Diseases Intestinal Neoplasms KRAS-mutant Colorectal Cancer (CRC) KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC) Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Other KRAS-mutant Solid Tumors Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KST-6051

Drug

KST-6051 will be administered orally as a tablet.

Primary outcomes

  1. Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days)

    Time frame: Up to Day 21 of Treatment Cycle 1

  2. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 2 years

    Clinically significant changes in safety assessments (vital signs, physical examinations, electrocardiograms, and clinical laboratory tests) are to be reported as adverse events.

  3. Number of Participants With Treatment-related Adverse Events (TRAEs)

    Time frame: Up to approximately 2 years

    Clinically significant changes in safety assessments (vital signs, physical examinations, electrocardiograms, and clinical laboratory tests) are to be reported as adverse events.

Secondary outcomes

  1. Maximum Observed Blood Concentration (Cmax) of KST-6051

    Time frame: Up to Week 6

  2. Time to Achieve Cmax (Tmax) of KST-6051

    Time frame: Up to Week 6

  3. Half-life (t1/2) of KST-6051

    Time frame: Up to Week 6

  4. Area Under the Blood Concentration-time Curve (AUC) of KST-6051

    Time frame: Up to Week 6

  5. Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years

  6. Disease Control Rate (DCR)

    Time frame: Up to approximately 2 years

  7. Duration of Overall Response (DOR)

    Time frame: Up to approximately 2 years

  8. Progression-free Survival (PFS)

    Time frame: Up to approximately 2 years

  9. Duration of Stable Disease

    Time frame: Up to approximately 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Kestrel Therapeutics, Inc.

CONTACT

[email protected]

617-612-6810

Sponsors and collaborators

Lead sponsor

Kestrel Therapeutics, Inc.

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 9, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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