NCT07615413Not yet recruitingPhase 1
A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10541 as Monotherapy or in Combination With Other Anti-cancer Therapies in Participants With KRAS G12C Mutation Advanced Solid Tumors.
Jiangsu Hansoh Pharmaceutical Co., Ltd.0 sites636 target enrollmentStarted: June 30, 2026Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 636
Study Overview
Brief Summary
This is a multicenter, open-label phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HS-10541 as monotherapy or in combination with other anti-cancer therapies in participants with KRAS G12C mutation advanced solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntary participation and written informed consent..
- •Aged 18 years or older (≥18 years), of any gender.
- •Histologically or cytologically confirmed advanced solid tumor.
- •At least one measurable lesion according to RECIST v1.
- •ECOG PS of 0 to 1, with no deterioration within 2 weeks prior to the first dose.
- •With a life expectancy > 12 weeks.
- •Adequate bone marrow reserve and organ function.
- •Female participants of childbearing potential and non-sterilized male participants must agree to use highly effective contraceptive measures from the time of signing the ICF until 6 months after the last dose.
- •Female participants of childbearing potential must be non-lactating; all female participants must have a negative pregnancy test prior to the first dose.
Exclusion Criteria
- •Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
- •Presence of symptomatic brain metastases, leptomeningeal/brainstem involvement, history of intracranial hemorrhage or intraspinal hemorrhage, or spinal cord compression.
- •Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
- •History of a second primary malignancy
- •Severe, uncontrolled, or active cardiovascular or cerebrovascular diseases, or severe cardiac examination abnormalities.
- •Severe or poorly controlled diabetes mellitus or hypertension.
- •Known active infectious diseases.
- •Clinically significant gastrointestinal dysfunction.
- •Gastrointestinal obstruction or perforation occured.
- •Interstitial lung disease (ILD).
- •Participants with known hypersensitivity or contraindications to any active or inactive ingredients of the study drug, chemically similar drugs, or drugs of the same class.
- •Other inappropriate situation considered by the investigator.
Investigators
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