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

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.

Interventions

• KST-6051 · DRUG

  KST-6051 will be administered orally as a tablet.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (9)

• Cedars-Sinai Medical Center, Los Angeles, California · RECRUITING
• Florida Cancer Specialists, Sarasota, Florida · RECRUITING
• Moffitt Cancer Center, Tampa, Florida · RECRUITING
• Mass General Brigham Cancer Institute at Massachusetts General Hospital, Boston, Massachusetts · RECRUITING
• Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania · RECRUITING
• The University of Texas MD Anderson Cancer Center, Houston, Texas · RECRUITING
• NEXT Oncology, San Antonio, Texas · RECRUITING
• Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah · RECRUITING
• NEXT Virginia, Fairfax, Virginia · RECRUITING