A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors

NCT ID: NCT06963502

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 762 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2030-04-30

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).

Conditions

Advanced Solid Tumors; Colorectal Cancer; Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1:HS-10370 dose 1+ HS-20117 dose 3

Group Type: EXPERIMENTAL

HS-10370

Intervention Type: DRUG

Participants will receive HS-10370 dose 1 administered orally

HS-20117

Intervention Type: DRUG

Participants will receive HS-20117 given as dose 3 intravenous infusion(IV) once every 14-day cycle.

Arm 2: HS-10370 dose 2 +HS-20117 dose 4+ Adebrelimab

Group Type: EXPERIMENTAL

HS-10370

Intervention Type: DRUG

Participants will receive HS-10370 dose 1 administered orally

HS-20117

Intervention Type: DRUG

Participants will receive HS-20117 given as dose 3 intravenous infusion(IV) once every 14-day cycle.

Adebrelimab

Intervention Type: DRUG

Participants will receive Adebrelimab intravenous infusion(IV) once every 21-day cycle

Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy

Group Type: EXPERIMENTAL

HS-10370

Intervention Type: DRUG

Participants will receive HS-10370 dose 1 administered orally

HS-20117

Intervention Type: DRUG

Participants will receive HS-20117 given as dose 3 intravenous infusion(IV) once every 14-day cycle.

Capecitabine

Intervention Type: DRUG

Participants will receive Capecitabine administered orally

Oxaliplatin

Intervention Type: DRUG

Participants will receive Oxaliplatin intravenous infusion(IV) once every 21-day cycle.

Arm 4: HS-10370 dose 1 + HS-20117 dose3 + Chemotherapy

Group Type: EXPERIMENTAL

HS-10370

Intervention Type: DRUG

Participants will receive HS-10370 dose 1 administered orally

HS-20117

Intervention Type: DRUG

Participants will receive HS-20117 given as dose 3 intravenous infusion(IV) once every 14-day cycle.

Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan

Intervention Type: DRUG

Participants will receive Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan intravenous infusion(IV) once every 14-day cycle.

Arm 5:HS-10370 dose1+ HS-20117 dose 4+HS-20093 dose 5

Group Type: EXPERIMENTAL

HS-10370

Intervention Type: DRUG

Participants will receive HS-10370 dose 1 administered orally

HS-20117

Intervention Type: DRUG

Participants will receive HS-20117 given as dose 3 intravenous infusion(IV) once every 14-day cycle.

HS-20093

Intervention Type: DRUG

Participants will receive HS-20093 intravenous infusion(IV) once every 21-day cycle

Arm 6:HS-10370 dose 2 +HS-20093 dose 5+ Adebrelimab

Group Type: EXPERIMENTAL

HS-10370

Intervention Type: DRUG

Participants will receive HS-10370 dose 1 administered orally

Adebrelimab

Intervention Type: DRUG

Participants will receive Adebrelimab intravenous infusion(IV) once every 21-day cycle

HS-20093

Intervention Type: DRUG

Participants will receive HS-20093 intravenous infusion(IV) once every 21-day cycle

Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy

Group Type: EXPERIMENTAL

HS-10370

Intervention Type: DRUG

Participants will receive HS-10370 dose 1 administered orally

Adebrelimab

Intervention Type: DRUG

Participants will receive Adebrelimab intravenous infusion(IV) once every 21-day cycle

HS-20093

Intervention Type: DRUG

Participants will receive HS-20093 intravenous infusion(IV) once every 21-day cycle

platinum (cisplatin or carboplatin)

Intervention Type: DRUG

Participants will receive platinum (cisplatin or carboplatin) administered IV in 21-day cycles.

Interventions

HS-10370

Participants will receive HS-10370 dose 1 administered orally

Intervention Type: DRUG

HS-20117

Participants will receive HS-20117 given as dose 3 intravenous infusion(IV) once every 14-day cycle.

Intervention Type: DRUG

Adebrelimab

Participants will receive Adebrelimab intravenous infusion(IV) once every 21-day cycle

Intervention Type: DRUG

Capecitabine

Participants will receive Capecitabine administered orally

Intervention Type: DRUG

Oxaliplatin

Participants will receive Oxaliplatin intravenous infusion(IV) once every 21-day cycle.

Intervention Type: DRUG

Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan

Participants will receive Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan intravenous infusion(IV) once every 14-day cycle.

Intervention Type: DRUG

HS-20093

Participants will receive HS-20093 intravenous infusion(IV) once every 21-day cycle

Intervention Type: DRUG

platinum (cisplatin or carboplatin)

Participants will receive platinum (cisplatin or carboplatin) administered IV in 21-day cycles.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Continuous use of glucocorticoids
• Active infectious diseases.
• Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
• Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child Pugh B-grade cirrhosis.
• Interstitial lung disease (ILD).
• Serious neurological or mental disorders.
• Active autoimmune diseases

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, , China

Sun Yat-sen University Cancer Center

Shanghai, , China

Countries

China

Facility Contacts

Xia Liu

Role: primary

hrec2013@126.com

(0086)0571-87783508

Xuzhi Pan

Role: primary

llwyh@sysucc.org.cn

020-87343009

Other Identifiers

HS-10370-103

Identifier Type: -

Identifier Source: org_study_id