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Clinical Trials in China / NCT06963502
Starting soon Phase 1

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

NCT06963502 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2025-05-30
Last updated
2025-05-09

Condition(s) studied

Advanced Solid TumorsColorectal CancerNon-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

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

HS-10370: Participants will receive HS-10370 dose 1 administered orally

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

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

Capecitabine: Participants will receive Capecitabine administered orally

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

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

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

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

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou China
Sun Yat-sen University Cancer Center Shanghai China

More Jiangsu Hansoh Pharmaceutical Co., Ltd. trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06963502 on ClinicalTrials.gov ↗ ← All trials in China