A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country81 target enrollmentJune 1, 2021

ConditionsAdvanced Solid Tumors

InterventionsSHR-1701；BP102

DrugsSHR-1701；BP102

Overview

Phase: Phase 1
Intervention: SHR-1701；BP102
Conditions: Advanced Solid Tumors
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 81
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this study was to assess the safety, tolerability, and efficacy when combining SHR-1701 and BP102 in participants with certain cancers. This study was conducted in 2 phases, Phase Ib and Phase II.

Registry

clinicaltrials.gov

Start Date

June 1, 2021

End Date

March 30, 2024

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

•Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable for which standard curative or palliative measures do not exist or are no longer effective (phase Ib)
•Histologically or cytologically confirmed metastatic or locally advanced solid tumors of the selected indications. (Phase II).
•.Life expectancy exceeds 12 weeeks;
•The Eastern Cancer Cooperative Group (ECOG) has a performance score of 0 or 1;
•Normal organ and marrow function;

Exclusion Criteria

•Has known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable.
•A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease.
•History of interstitial lung disease or pneumonia requiring oral or intravenous steroids.
•Has moderate or severe cardiovascular disease;
•Active HBV(hepatitis B) or HCV (Hepatitis C virus)-infected subjects;
•Any other malignancies within 5 years except for those with negligible risk of metastasis or death.

Arms & Interventions

SHR -1701 + BP102

Intervention: SHR-1701；BP102

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: 2 years

recommended phase 2 dose (Phase Ib)

Time Frame: At the end of Cycle 2 (each cycle is 21 days)

Secondary Outcomes

Disease control rate (DCR)(2 years)
Duration of response (DOR)(2 years)
Time to response(TTR)(2 years)
Dose Limiting Toxicity (DLT) (Phase 1b)(At the end of Cycle 2 (each cycle is 21 days))
Number of participants with treatment emergent adverse events (TEAEs)(For each participant, from the first dose till 90 days after the last dose)
Number of participants with treatment emergent serious adverse events (SAEs)(For each participant, from the first dose till 90 days after the last dose)
ORR(2 years)
Progression-free survival (PFS)(2 years)
Overall survival (OS)(2 years)