• A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Participants with KRAS G12C Mutation Advanced Solid Tumors

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ClinicalTrials.gov ID

NCT06963502

Lead Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.INDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 1

Enrollment

762Estimated

Last Update Posted

May 9, 2025Actual

Start Date

May 30, 2025Estimated

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Apr 30, 2030Estimated

Official Title

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

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).

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

• HS-10370
• HS-20117
• Adebrelimab
• Capecitabine
• Oxaliplatin
• Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan
• HS-20093
• platinum (cisplatin or carboplatin)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.INDUSTRY

llwyh@sysucc.org.cn020-87343009