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)
Number of Participants with Adverse Event(s) (AEs) — From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days). 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)
Trial sites (2)
Facility
City
Region
Status
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
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.
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