Trial of SHR-1701 Plus BP102 in Subjects With Selected So... | NCT04856774

Studies
Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors

NCT04856774

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Status

Completed

Last Update Posted

Jun 27, 2024Actual

Enrollment

81Actual

Phase

Phase 1Phase 2

Conditions

Advanced Solid Tumors

Interventions

SHR-1701；BP102

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Mar 30, 2024Actual

Completion Date

Mar 30, 2024Actual

First Submitted Date

Apr 19, 2021

First Submission Date that Met QC Criteria

Apr 22, 2021

First Posted Date

Apr 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2024

Last Update Posted Date

Jun 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SHR -1701 + BP102	Experimental		Drug: SHR-1701；BP102

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHR-1701；BP102	Drug	Drug: SHR-1701 IV infusion Drug: BP102 IV infusion Phase Ib: SHR-1701 30mg/kg + BP102 15mg/kg Q3w as starting dose, until recommended phase 2 dose is determined.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recommended phase 2 dose (Phase Ib)		At the end of Cycle 2 (each cycle is 21 days)
Objective response rate (ORR)		2 years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided