KRAS G12C Mutation Advanced Solid TumorPhase 1NCT07615413
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 1 study testing HS-10541 in people with KRAS G12C Mutation Advanced Solid Tumor, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS G12C Mutation Advanced Solid Tumor
- What is being tested?
- HS-10541
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 636 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 v1.1.
- ECOG PS of 0 to 1, with no deterioration within 2 weeks prior to the first dose.
- With a life expectancy > 12 weeks.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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.
- Conditions
- KRAS G12C Mutation Advanced Solid Tumor
- Being tested
- HS-10541
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10541Drug
HS-10541 will be administered orally once daily in a continuous regimen
| Study group | Role | What they receive |
|---|---|---|
| HS-10541 | Experimental | Participants in all subjects will receive HS-10541 Receives: Drug: HS-10541 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Number of participants with dose limiting toxicities.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Approximately 1.5 years
Secondary outcomes (10)
PK profile of HS-10541as monotherapy, or combination therapy
The maximum concentration (Cmax)
Measured: 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)
Measured: 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)
Measured: 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-∞)
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Approximately 3 years.
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).
Measured: Approximately 1.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS G12C Mutation Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 636 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615413
- Sponsor's protocol ID
- HS-10541-101
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07615413
- Acronym / sponsor ID
- HS-10541-101
- Conditions
- KRAS G12C Mutation Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 636 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-10541 | Experimental | Drug: HS-10541Participants in all subjects will receive HS-10541 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 v1.1.
- ECOG PS of 0 to 1, with no deterioration within 2 weeks prior to the first dose.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10541HS-10541 will be administered orally once daily in a continuous regimen | Drug | HS-10541 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: From Cycle 1 Day 1 through Day 21. A cycle is 21 days.
Number of participants with dose limiting toxicities.
Adverse events (AEs)
Time frame: Approximately 1.5 years.
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).
Objective response rate (ORR)
Time frame: Approximately 1.5 years.
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).
Progression-free survival (PFS)
Time frame: Approximately 1.5 years
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.
10 secondary outcomes
PK profile of HS-10541as monotherapy, or combination therapy
Time frame: Pre-dose and postdose up to end of treatment, approximately 1.5 years.
PK profile of HS-10541as monotherapy, or combination therapy
Time frame: Pre-dose and postdose up to end of treatment, approximately 1.5 years
PK profile of HS-10541as monotherapy, or combination therapy
Time frame: Pre-dose and postdose up to end of treatment, approximately 1.5 years
PK profile of HS-10541as monotherapy, or combination therapy
Time frame: Pre-dose and postdose up to end of treatment, approximately 1.5 years.
ORR
Time frame: Approximately 1.5 years.
Disease control rate (DCR)
Time frame: Approximately 1.5 years.
Duration of response (DoR)
Time frame: Approximately 1.5 years
PFS
Time frame: Approximately 1.5 years
Overall Survival (OS)
Time frame: Approximately 3 years.
Adverse events (AEs)
Time frame: Approximately 1.5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10541 in people with KRAS G12C Mutation Advanced Solid Tumor, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: From Cycle 1 Day 1 through Day 21. A cycle is 21 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.