Clinical Trials/NCT06754930

NCT06754930

Recruiting

Phase 1

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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country400 target enrollmentFebruary 18, 2025

ConditionsNon-small Cell Lung Cancer (NSCLC)

InterventionsSHR-1826 SHR-1316 SHR-9839 SHR-8068 Ametinib mesylate BP-102 Carboplatin

DrugsSHR-1826 SHR-1316 SHR-9839 SHR-8068 Ametinib mesylate BP-102 Carboplatin

Overview

Phase: Phase 1
Intervention: SHR-1826
Conditions: Non-small Cell Lung Cancer (NSCLC)
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 400
Locations: 1
Primary Endpoint: Recommended phase II dose (RP2D)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 18, 2025

End Date

December 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntary participation and written informed consent.
•18-75 years older, no gender limitation.
•Eastern Cooperative Oncology Group (ECOG) score: 0-
•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.
•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 Criteria

•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.

Arms & Interventions

Experimental group

Intervention: SHR-1826

Experimental group

Intervention: SHR-1316

Experimental group

Intervention: SHR-9839

Experimental group

Intervention: SHR-8068

Experimental group

Intervention: Ametinib mesylate

Experimental group

Intervention: BP-102

Experimental group

Intervention: Carboplatin

Outcomes

Primary Outcomes

Recommended phase II dose (RP2D)

Time Frame: Screening up to study completion, an average of 1 year.

Adverse events (AEs)

Time Frame: Screening up to study completion, an average of 1 year.

Objective response rate (ORR)

Time Frame: Screening up to study completion, an average of 1 year.

Secondary Outcomes

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.)