A Phase 1 Dose-escalation Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KST-6051.
- Who it may be relevant to
- Registry conditions: KRAS-mutant Non-small Cell Lung Cancer (NSCLC), KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC), KRAS-mutant Colorectal Cancer (CRC), Other KRAS-mutant Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Interventions
- Drug KST-6051
KST-6051 will be administered orally as a tablet.
Primary outcome measures
- 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]
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to approximately 2 years]
- Number of Participants With Treatment-related Adverse Events (TRAEs) [Time frame: Up to approximately 2 years]
Secondary outcome measures (9)
- Maximum Observed Blood Concentration (Cmax) of KST-6051 [Time frame: Up to Week 6]
- Time to Achieve Cmax (Tmax) of KST-6051 [Time frame: Up to Week 6]
- Half-life (t1/2) of KST-6051 [Time frame: Up to Week 6]
- Area Under the Blood Concentration-time Curve (AUC) of KST-6051 [Time frame: Up to Week 6]
- Objective Response Rate (ORR) [Time frame: Up to approximately 2 years]
- Disease Control Rate (DCR) [Time frame: Up to approximately 2 years]
- Duration of Overall Response (DOR) [Time frame: Up to approximately 2 years]
- Progression-free Survival (PFS) [Time frame: Up to approximately 2 years]
- Duration of Stable Disease [Time frame: Up to approximately 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Cedars-Sinai Medical Center — Los Angeles
- Florida Cancer Specialists — Sarasota
- Moffitt Cancer Center — Tampa
- Mass General Brigham Cancer Institute at Massachusetts General Hospital — Boston
- Sidney Kimmel Cancer Center — Philadelphia
- The University of Texas MD Anderson Cancer Center — Houston
- NEXT Oncology — San Antonio
- Huntsman Cancer Institute, University of Utah — Salt Lake City
- … and 1 more center
Identifiers
NCT: NCT07458347 · KST-6051-101