Clinical trial · Interventional
A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors
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
NCT06963502CI-TRIAL-00089479not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan | Drug | — | UNRESOLVED |
| HS-10370 | Drug | — | UNRESOLVED |
| HS-20093 | Drug | — | UNRESOLVED |
| HS-20117 | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| platinum (cisplatin or carboplatin) | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Arm 1:HS-10370 dose 1+ HS-20117 dose 3
- interventionNames
- Drug: HS-10370
- Drug: HS-20117
- type
- EXPERIMENTAL
- label
- Arm 2: HS-10370 dose 2 +HS-20117 dose 4+ Adebrelimab
- interventionNames
- Drug: HS-10370
- Drug: HS-20117
- Drug: Adebrelimab
- type
- EXPERIMENTAL
- label
- Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy
- interventionNames
- Drug: HS-10370
- Drug: HS-20117
- Drug: Capecitabine
- Drug: Oxaliplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.