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Not Yet Recruiting NCT07836036

Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations

Conditions: Solid Tumor, RAS Mutation

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 200
Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Location: Peking University Cancer Hospital Beijing

Summary

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

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07836036). StuddyBuddy aggregates publicly available trial information.