Clinical trial · Interventional
A Phase 1 Dose-escalation Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation
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
NCT07458347CI-TRIAL-00116151recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| KRAS-mutant Colorectal Cancer (CRC) | Colorectal Carcinoma | ALIAS | 0.85 |
| KRAS-mutant Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ALIAS | 0.85 |
| Other KRAS-mutant Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KST-6051 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- KST-6051 Dose Escalation
- description
- Sequential cohorts with increasing doses of KST-6051 will be evaluated to determine recommended dose(s) for expansion (RDE\[s\]).
- interventionNames
- Drug: KST-6051
Primary outcomes (3)
- measure
- Number of Participants With Dose-limiting Toxicities (DLTs) at the end of Cycle 1 (Each Cycle is 21 Days)
- timeFrame
- Up to Day 21 of Treatment Cycle 1
- measure
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- timeFrame
- Up to approximately 2 years
- description
- Clinically significant changes in safety assessments (vital signs, physical examinations, electrocardiograms, and clinical laboratory tests) are to be reported as adverse events.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.