NCT06703177

Recruiting

Phase 1

Phase IB/II Study of Safety, Tolerability and Efficacy of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country876 target enrollmentFebruary 18, 2025

InterventionsFluorouracil Injection Calcium Folinate Injection Adebrelimab Injection SHR-1826 SHR-4642 SHR-9839 SHR-8068 Bevacizumab Injection Capecitabine tablets

Overview

Phase: Phase 1
Intervention: Fluorouracil Injection
Conditions: Advanced Solid Tumors
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 876
Locations: 1
Primary Endpoint: RP2D (Phase 1)
Status: Recruiting
Last Updated: 5 months ago

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 advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

February 18, 2025

End Date

July 1, 2027

Last Updated

5 months ago

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: 0-1;
•With a life expectancy ≥ 3 months;
•Pathologically diagnosed advanced solid tumor;
•Be able to provide fresh or archived tumour tissue;
•At least one measurable lesion according to RECIST v1.1;
•Adequate bone marrow reserve and 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;
•Previously received antiboy-coupled drug therapy with topoisomerase I inhibitor toxin; Previously received EGFR/c-Met double antibody;
•Received systemic antitumor therapy before the first dose;
•Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing;
•For the first time, a study was conducted to treat patients with radiation therapy exceeding the prescribed dose before study treatment;
•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;

Arms & Interventions

Single group

Intervention: Fluorouracil Injection

Single group

Intervention: Calcium Folinate Injection

Single group

Intervention: Adebrelimab Injection

Single group

Intervention: SHR-1826

Single group

Intervention: SHR-4642

Single group

Intervention: SHR-9839

Single group

Intervention: SHR-8068

Single group

Intervention: Bevacizumab Injection

Single group

Intervention: Capecitabine tablets

Outcomes

Primary Outcomes

RP2D (Phase 1)

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

AE (Phase 1)

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

Objective response rate (ORR) (Phase 2)

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

Secondary Outcomes

Objective response rate (ORR) (Phase 1)(Screening up to study completion, an average of 1 year.)
Disease control rate (DCR) (Phase 1)(Screening up to study completion, an average of 1 year.)
Duration of response (DoR) (Phase 1)(Screening up to study completion, an average of 1 year.)
Progression-free survival (PFS) (Phase 1)(Screening up to study completion, an average of 1 year.)
Overall survival (OS) (Phase 1)(Screening up to study completion, an average of 1 year.)
Drug Resistant Antibody (ADA) (Phase 1)(Screening up to study completion, an average of 1 year.)
Blood concentration of SHR-1826 (Phase 1)(Screening up to study completion, an average of 1 year.)
Blood concentration of free toxin SHR169265 (Phase 1)(Screening up to study completion, an average of 1 year.)
Disease control rate (DCR) (Phase 2)(Screening up to study completion, an average of 1 year.)
Duration of response (DoR) (Phase 2)(Screening up to study completion, an average of 1 year.)
Progression-free survival (PFS) (Phase 2)(Screening up to study completion, an average of 1 year.)
Overall survival (OS) (Phase 2)(Screening up to study completion, an average of 1 year.)
AE (Phase 2)(Screening up to study completion, an average of 1 year.)