A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Participants with KRAS G12C Mutation Advanced Solid Tumors

Trial Title: A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Participants with KRAS G12C Mutation Advanced Solid Tumors

NCT ID: NCT06594874

Condition: Non-Small Cell Lung Cancer
Advanced Solid Tumors

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pemetrexed

Conditions: Keywords:
KRAS G12C
Non-Small Cell Lung Cancer
Metastatic Solid Tumor
Adebrelimab
Carboplatin
Pemetrexed
Cisplatin

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: HS-10370
Description: HS-10370 administered orally every day
Arm group label: Arm A: HS-10370 dose 1 + Adebrelimab
Arm group label: Arm B: HS-10370 dose 2 + Adebrelimab
Arm group label: Arm C: HS-10370+ Adebrelimab + Pemetrexed and Platinum
Arm group label: Arm D: HS-10370+ Adebrelimab + Pemetrexed
Arm group label: Arm E: HS-10370+ Pemetrexed and Platinum

Intervention type: Drug
Intervention name: Adebrelimab
Description: Administered intravenously every 21 days; dose by label.
Arm group label: Arm A: HS-10370 dose 1 + Adebrelimab
Arm group label: Arm B: HS-10370 dose 2 + Adebrelimab
Arm group label: Arm C: HS-10370+ Adebrelimab + Pemetrexed and Platinum
Arm group label: Arm D: HS-10370+ Adebrelimab + Pemetrexed

Intervention type: Drug
Intervention name: Cisplatin
Description: Administered intravenously every 21 days; dose by label.
Arm group label: Arm C: HS-10370+ Adebrelimab + Pemetrexed and Platinum
Arm group label: Arm E: HS-10370+ Pemetrexed and Platinum

Intervention type: Drug
Intervention name: Carboplatin
Description: Administered intravenously every 21 days; dose by label.
Arm group label: Arm C: HS-10370+ Adebrelimab + Pemetrexed and Platinum
Arm group label: Arm E: HS-10370+ Pemetrexed and Platinum

Intervention type: Drug
Intervention name: Pemetrexed
Description: Administered intravenously every 21 days; dose by label.
Arm group label: Arm C: HS-10370+ Adebrelimab + Pemetrexed and Platinum
Arm group label: Arm D: HS-10370+ Adebrelimab + Pemetrexed
Arm group label: Arm E: HS-10370+ Pemetrexed and Platinum

Summary: This is a Phase Ib study that will evaluate the Safety, Tolerability , Pharmacokinetics and Activity of HS-10370 in Combination With Other Anti-cancer Therapies in patients with KRAS G12C mutation advanced or metastatic solid tumors, especially in non-Small cell lung cancer (NSCLC) .

Criteria for eligibility:
Criteria:
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. - Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy. - Documentation of the presence of a KRAS G12C mutation - Must provide tumor tissue sample - No history of systemic anticancer therapy in metastatic/non-curable settings - 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. - Females must have the evidence of non-childbearing potential; Likewise, men also consent to use adequate contraceptive method within the same time limit. - Signed and dated Informed Consent Form. - The subjects are able to comply with the process of the protocol. Exclusion Criteria: - Treatment with any of the following: 1. Previous or current treatment with other KRAS G12C inhibitors 2. Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of study treatment; Any investigational agents and large molecule antibodies within 28 days of the first dose of study treatment. 3. Local radiotherapy within 2 weeks prior to the first dose of study drug, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of study drug. 4. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose - 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Union Hospital Tong Ji Medical College, HuaZhong University of Science and Technology

Address:
City: Wuhan
Country: China

Start date: October 31, 2024

Completion date: January 1, 2027

Lead sponsor:
Agency: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Agency class: Industry

Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06594874