Status:
NOT_YET_RECRUITING
A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Advanced Solid Tumors
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2030
Estimated Enrollment :
762 Patients enrolled
Trial Details
Trial ID
NCT06963502
Start Date
May 30 2025
End Date
April 30 2030
Last Update
May 9 2025
Active Locations (2)
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1
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
2
Sun Yat-sen University Cancer Center
Shanghai, China