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

Hansoh Pharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Advanced Solid Tumors; Non-Small Cell Lung Cancer; Colorectal Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06963502

HS-10370-103

Details and patient eligibility

About

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).

Enrollment: 762 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

762 participants in 7 patient groups

Arm 1:HS-10370 dose 1+ HS-20117 dose 3

Experimental group

Treatment:

Drug: HS-10370

Drug: HS-20117

Arm 2: HS-10370 dose 2 +HS-20117 dose 4+ Adebrelimab

Experimental group

Treatment:

Drug: Adebrelimab

Drug: HS-10370

Drug: HS-20117

Arm 3: HS-10370 dose 1 + HS-20117 dose4 + Chemotherapy

Experimental group

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine

Drug: HS-10370

Drug: HS-20117

Arm 4: HS-10370 dose 1 + HS-20117 dose3 + Chemotherapy

Experimental group

Treatment:

Drug: Folinic Acid, Fluorouracil and Oxaliplatin/Irinotecan

Drug: HS-10370

Drug: HS-20117

Arm 5:HS-10370 dose1+ HS-20117 dose 4+HS-20093 dose 5

Experimental group

Treatment:

Drug: HS-20093

Drug: HS-10370

Drug: HS-20117

Arm 6:HS-10370 dose 2 +HS-20093 dose 5+ Adebrelimab

Experimental group

Treatment:

Drug: Adebrelimab

Drug: HS-20093

Drug: HS-10370

Arm 7:HS-10370 dose 2 +HS-20093 dose 6+ Adebrelimab+ Chemotherapy

Experimental group

Treatment:

Drug: platinum (cisplatin or carboplatin)

Drug: Adebrelimab

Drug: HS-20093

Drug: HS-10370