Phase 1 Study of HS-10541 as Monotherapy or in Combination With Other Anti-cancer Therapies in Patients With KRAS G12C Mutation Advanced Solid Tumors.

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.

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 Overview

• Status: Not yet recruiting
• Conditions: KRAS G12C Mutation Advanced Solid Tumor
• Intervention / Treatment: Drug: HS-10541

• Study Type: Interventional
• Enrollment (Estimated): 636
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntary participation and written informed consent..
2. Aged 18 years or older (≥18 years), of any gender.
3. Histologically or cytologically confirmed advanced solid tumor.
4. At least one measurable lesion according to RECIST v1.1.
5. ECOG PS of 0 to 1, with no deterioration within 2 weeks prior to the first dose.
6. With a life expectancy > 12 weeks.
7. Adequate bone marrow reserve and organ function.
8. 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.
9. 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:

1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
2. Presence of symptomatic brain metastases, leptomeningeal/brainstem involvement, history of intracranial hemorrhage or intraspinal hemorrhage, or spinal cord compression.
3. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
4. History of a second primary malignancy
5. Severe, uncontrolled, or active cardiovascular or cerebrovascular diseases, or severe cardiac examination abnormalities.
6. Severe or poorly controlled diabetes mellitus or hypertension.
7. Known active infectious diseases.
8. Clinically significant gastrointestinal dysfunction.
9. Gastrointestinal obstruction or perforation occured.
10. Interstitial lung disease (ILD).
11. 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.
12. Other inappropriate situation considered by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-10541; Participants in all subjects will receive HS-10541	Drug: HS-10541; HS-10541 will be administered orally once daily in a continuous regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity (DLT)	Number of participants with dose limiting toxicities.	From Cycle 1 Day 1 through Day 21. A cycle is 21 days.
Adverse events (AEs)	Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from the date of first dose to 28 days (monotherapy) or 90 days (combination therapy) after the final dose (or as specified in the protocol).	Approximately 1.5 years.
Objective response rate (ORR)	Defined as the percentage of participants with a best overall response of partial response or better per response evaluation criteria in solid tumors (RECIST 1.1).	Approximately 1.5 years.
Progression-free survival (PFS)	Defined as from the date of first dose to the date of disease progression according to investigator assessment or death due to any cause, whichever occurs first.	Approximately 1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from the date of first dose to 28 days (monotherapy) or 90 days (combination therapy) after the final dose (or as specified in the protocol).	Approximately 1.5 years.
PK profile of HS-10541as monotherapy, or combination therapy	The maximum concentration (Cmax)	Pre-dose and postdose up to end of treatment, approximately 1.5 years.
PK profile of HS-10541as monotherapy, or combination therapy	Time to the maximum concentration (Tmax)	Pre-dose and postdose up to end of treatment, approximately 1.5 years
PK profile of HS-10541as monotherapy, or combination therapy	Area under the concentration time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC0-t)	Pre-dose and postdose up to end of treatment, approximately 1.5 years
PK profile of HS-10541as monotherapy, or combination therapy	Area under the concentration time curve from time zero to infinity (AUC0-∞)	Pre-dose and postdose up to end of treatment, approximately 1.5 years.
ORR	Defined as the percentage of participants with a best overall response of partial response or better per response evaluation criteria in solid tumors (RECIST 1.1).	Approximately 1.5 years.
Disease control rate (DCR)	Defined as the percentage of participants with a best overall response of stable disease or better per RECIST 1.1.	Approximately 1.5 years.
Duration of response (DoR)	Defined as the time from date of first documented evidence of partial response or better to the date of disease progression or death due to any cause	Approximately 1.5 years
PFS	Defined as from the date of first dose to the date of disease progression according to investigator assessment or death due to any cause, whichever occurs first.	Approximately 1.5 years
Overall Survival (OS)	Defined as the time from date of first dose to the date of death due to any cause	Approximately 3 years.

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HS-10541-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No