← Back to all trials
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
Source: ClinicalTrials.gov (NCT07836036). StuddyBuddy aggregates publicly available trial information.