Advanced Solid TumorsPhase 1NCT06963398
A Study of HS-10529 in KRAS G12D Patients With Advanced Solid Tumors
A Phase 1 study testing HS-10529 in people with Advanced Solid Tumors, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial summary
HS-10529 is an oral, highly selective, small molecular inhibitor of KRAS G12D. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10529 in KRAS G12D patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HS-10529
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2025to 30 Aug 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
- At least age of 18 years at screening.
- Patients of advanced solid tumor，who have progressed on or intolerant to standard therapy.
- With measurable lesion according to RECIST 1.1.
- Agree to provide fresh or archival tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
Who cannot join
- Previous or current treatment with KRAS G12D inhibitors.
- Uncontrolled pleural, ascites or pericardial effusion.
- Known and untreated, or active central nervous system metastases.
- History of other primary malignant tumors.
- Serious, uncontrolled, or active comorbidities.
- Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1 Study, Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10529 Monotherapy in KRAS G12D Patients With Advanced Solid Tumors
HS-10529 is an oral, highly selective, small molecular inhibitor of KRAS G12D. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10529 in KRAS G12D patients with advanced solid tumors.
Read the detailed description
This is a phase 1, first-in-human, study of HS-10529, consisting of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of HS-10529 in KRAS G12D patients with advanced solid tumors and evaluate the preliminary efficacy of HS-10529.
- Conditions
- Advanced Solid Tumors
- Being tested
- HS-10529
- Keywords
- Advanced Solid Tumors, KRAS G12D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10529Drug
Participants in all subjucts will receive HS-10529
| Study group | Role | What they receive |
|---|---|---|
| HS-10529 | Experimental | Not described Receives: Drug: HS-10529 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD) or maximum applicable dose (MAD)
Measured: up to 24 months
Secondary outcomes (2)
Incidence and severity of treatment-emergent adverse events
Measured: up to 24 months
Plasma concentration of HS-10529
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start15 May 2025 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- 520 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
- NCT06963398
- Sponsor's protocol ID
- HS-10529-101
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 9 May 2025
- 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 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study, Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10529 Monotherapy in KRAS G12D Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06963398
- Acronym / sponsor ID
- HS-10529-101
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors, KRAS G12D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 9 May 2025 (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.
HS-10529 is an oral, highly selective, small molecular inhibitor of KRAS G12D. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10529 in KRAS G12D patients with advanced solid tumors.
Detailed description
This is a phase 1, first-in-human, study of HS-10529, consisting of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of HS-10529 in KRAS G12D patients with advanced solid tumors and evaluate the preliminary efficacy of HS-10529.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-10529 | Experimental | Drug: HS-10529 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least age of 18 years at screening.
- Patients of advanced solid tumor，who have progressed on or intolerant to standard therapy.
- With measurable lesion according to RECIST 1.1.
- Agree to provide fresh or archival tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
Key exclusion criteria (6 listed)
- Previous or current treatment with KRAS G12D inhibitors.
- Uncontrolled pleural, ascites or pericardial effusion.
- Known and untreated, or active central nervous system metastases.
- History of other primary malignant tumors.
- Serious, uncontrolled, or active comorbidities.
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-10529Participants in all subjucts will receive HS-10529 | Drug | HS-10529 |
Primary outcome
The maximum tolerated dose (MTD) or maximum applicable dose (MAD)
Time frame: up to 24 months
2 secondary outcomes
Incidence and severity of treatment-emergent adverse events
Time frame: up to 24 months
Plasma concentration of HS-10529
Time frame: up to 36 months
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 9 May 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10529 in people with Advanced Solid Tumors, 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 5 inclusion and 6 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 9 May 2025. 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?
Contact Fangbin Liu (19916299227, liufb@hspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum tolerated dose (MTD) or maximum applicable dose (MAD) (time frame: up to 24 months). 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 9 May 2025.