RecruitingPhase 1Phase 2NCT06754930

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

A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

400 participants

Start Date

Feb 18, 2025

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer (NSCLC)

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

Voluntary participation and written informed consent.
years older, no gender limitation.
Eastern Cooperative Oncology Group (ECOG) score: 0-1.
With a life expectancy ≥ 3 months.
Pathologically diagnosed NSCLC.
Be able to provide fresh or archived tumour tissue.
At least one measurable lesion according to RECIST v1.1.
Adequate organ function.
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 Criteria11

Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
Previous or co-existing malignancies.
Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
Uncontrollable tumor-related pain.
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.
Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment.
Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy.
With poorly controlled or severe cardiovascular disease.
Active hepatitis B and hepatitis C.
Patients with a history of immunodeficiency.
Severe infection 30 days before the first dose.