A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC

Phase 1

Recruiting

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Drug: SHR-1826; Drug: SHR-1316; Drug: SHR-9839; Drug: SHR-8068; Drug: Ametinib mesylate; Drug: BP-102; Drug: Carboplatin

• Registration Number: NCT06754930
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief Summary

This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2024-12-24
• Study First Posted: 2025-01-01
• Study Start: 2025-02-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Voluntary participation and written informed consent.
2. 18-75 years older, no gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
4. With a life expectancy ≥ 3 months.
5. Pathologically diagnosed NSCLC.
6. Be able to provide fresh or archived tumour tissue.
7. At least one measurable lesion according to RECIST v1.1.
8. Adequate organ function.
9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

Exclusion Criteria

1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
2. Previous or co-existing malignancies.
3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
4. Uncontrollable tumor-related pain.
5. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing.
6. Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment.
7. Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy.
8. With poorly controlled or severe cardiovascular disease.
9. Active hepatitis B and hepatitis C.
10. Patients with a history of immunodeficiency.
11. Severe infection 30 days before the first dose.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	SHR-1826	-
Experimental group	SHR-1316	-
Experimental group	SHR-9839	-
Experimental group	SHR-8068	-
Experimental group	Ametinib mesylate	-
Experimental group	Carboplatin	-
Experimental group	BP-102	-

Primary Outcome Measures

Name	Time	Method
Recommended phase II dose (RP2D)	Screening up to study completion, an average of 1 year.
Adverse events (AEs)	Screening up to study completion, an average of 1 year.
Objective response rate (ORR)	Screening up to study completion, an average of 1 year.

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	Screening up to study completion, an average of 1 year.
Duration of response (DoR)	Screening up to study completion, an average of 1 year.
Progression-free survival (PFS)	Screening up to study completion, an average of 1 year.
Overall survival (OS)	Screening up to study completion, an average of 1 year.
Drug resistant antibody (ADA) to SHR-1826	Screening up to study completion, an average of 1 year.
Blood concentration of SHR-1826	Screening up to study completion, an average of 1 year.
Blood concentration of free toxin	Screening up to study completion, an average of 1 year.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China