A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors
A Phase Ib Study Evaluating the Safety, Tolerability , Pharmacokinetics，Activity and Immunogenicity of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors
1 other identifier
interventional
762
1 country
2
Brief Summary
This is a Phase Ib study that will evaluate the Safety, Tolerability , Pharmacokinetics, Activity and Immunogenicity of HS-10370 in Combination With Other Anti-cancer Therapies in Chinese patients with KRAS G12C mutation advanced or metastatic solid tumors, especially in and Colorectal cancer(CRC) and non-Small cell lung cancer (NSCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2025
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2025
CompletedFirst Posted
Study publicly available on registry
May 9, 2025
CompletedStudy Start
First participant enrolled
May 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2030
May 9, 2025
April 1, 2025
3.6 years
April 16, 2025
May 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Event(s) (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with this treatment. Severity is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).
Secondary Outcomes (9)
Overall Response Rate (ORR)
From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).
Disease Control Rate (DCR)
From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).
Time to Response (TTR)
Time from Cycle 1 Day 1 until the date that measurement criteria for CR or PR (whichever is first recorded) are first met, up to 2 years (each cycle is 14 days).
Duration of Response (DOR)
Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years
Progression-Free Survival (PFS)
Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years
- +4 more secondary outcomes
Study Arms (7)
Arm 1:HS-10370 dose 1+ HS-20117 dose 3
EXPERIMENTALArm 2: HS-10370 dose 2 +HS-20117 dose 4+ Adebrelimab
EXPERIMENTALArm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy
EXPERIMENTALArm 4: HS-10370 dose 1 + HS-20117 dose3 + Chemotherapy
EXPERIMENTALArm 5:HS-10370 dose1+ HS-20117 dose 4+HS-20093 dose 5
EXPERIMENTALArm 6:HS-10370 dose 2 +HS-20093 dose 5+ Adebrelimab
EXPERIMENTALArm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy
EXPERIMENTALInterventions
Participants will receive HS-10370 dose 1 administered orally
Participants will receive HS-20117 given as dose 3 intravenous infusion(IV) once every 14-day cycle.
Participants will receive Adebrelimab intravenous infusion(IV) once every 21-day cycle
Participants will receive Capecitabine administered orally
Participants will receive Oxaliplatin intravenous infusion(IV) once every 21-day cycle.
Participants will receive Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan intravenous infusion(IV) once every 14-day cycle.
Participants will receive HS-20093 intravenous infusion(IV) once every 21-day cycle
Participants will receive platinum (cisplatin or carboplatin) administered IV in 21-day cycles.
Eligibility Criteria
You may qualify if:
- Men or women greater than or equal to 18 years
- At least one measurable lesion in accordance with RECIST 1.1
- Must have an ECOG performance status of 0 or 1.
- Patients with advanced solid tumors who have failed after adequate standard treatment, are intolerant to standard treatment, or have no standard treatment available.
- Documentation of the presence of a KRAS G12C mutation
- Estimated life expectancy ≥12 weeks.
- Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose.Men also consent to use adequate contraceptive method within the same time limit.
- The subjects are able to comply with the process of the protocol.
You may not qualify if:
- Treatment with any of the following: Previous or current treatment with other KRAS G12C inhibitors.
- Active brain metastases.
- Patients with uncontrolled pleural, ascites or pericardial effusion
- Spinal cord compression
- Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
- Subjects with tumors known to harbor molecular alterations for which targeted therapy is locally approved, except for KRAS G12C.
- History of other primary malignancies.
- Inadequate bone marrow reserve or organ functions.
- Abnormal cardiac examination results.
- Severe, uncontrolled or active cardiovascular disorders.
- Diabetes ketoacidosis or hyperglycemia hyperosmolality
- Uncontrolled hypertension.
- Severe bleeding symptoms or bleeding tendencies.
- Severe arteriovenous thrombosis occurred
- Serious infection.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Sun Yat-sen University Cancer Center
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2025
First Posted
May 9, 2025
Study Start
May 30, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
April 30, 2030
Last Updated
May 9, 2025
Record last verified: 2025-04