Clinical trial · Interventional
Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
A Phase I, Multi-center, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ASKC189 in Chinese Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors Carrying RAS Gene Mutations.
NCT07836036CI-TRIAL-00126556not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ASKC189 in in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| RAS Mutation | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ASKC189 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ASKC189 oral capsule
- interventionNames
- Drug: ASKC189
Primary outcomes (2)
- measure
- The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
- timeFrame
- Up to 21 days following first dose
- description
- DLT is short for Dose Limiting Toxicity, dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
- measure
- Number of participants with adverse events and serious adverse events as assessed by CTCAE v6.0
- timeFrame
- Up to 30 days following last dose
- description
- AE refers to any untoward medical occurrence or deterioration of existing medical event after the investigational treatment, whether or not considered related to the study treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged ≥18 years old at the time of informed consent 2. Able to provide informed consent voluntarily before any study-related activities and according to local guidelines 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 4. Have an estimated life expectancy ≥ 12 weeks 5. Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available standard therapies. 6. Documentation of KRAS/NRAS/HRAS mutation determined by validated local testing of tumor tissue or circulating free DNA (cfDNA) in a certified laboratory 7. Have consented to provide archival tumor tissue collected within 3 years or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. 8. Have adequate organ functions 9. Have discontinued all previous treatments for cancer with resolution of any adverse events (AEs) to ≤ Grade 1 Exclusion Criteria: 1. Are currently enrolled in a clinical study involving an investigational product or any other type of medical research 2. Have tumors previously tested positive for Class I BRAF mutations i.e. V600X 3. Prior treatment with a pan-RAS(ON) inhibitor 4. Gastrointestinal conditions that may interfere with drug absorption 5. Have a serious concomitant systemic disorder 6. Have a serious pre-existing medical condition(s) 7. Prior or second concurrent primary malignancies 8. Moderate or severe cardiovascular disease 9. Have symptomatic central nervous system (CNS) malignancy or metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.