- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04856774
Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
August 9, 2021 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
113
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hao Shen
- Phone Number: +0518-82342973
- Email: hao.shen@hengrui.com
Study Contact Backup
- Name: Yiyuan Pan
- Phone Number: 15258682523
- Email: yiyuan.pan@hengrui.com
Study Locations
-
-
Guangzhou
-
Guangzhou, Guangzhou, China, 510060
- Recruiting
- Sun Yat-Sen University Cancer Center
-
Contact:
- Ruihua Xu, Doctor
- Phone Number: +86-20-87343468
- Email: xurh@sysucc.org.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHR -1701 + BP102
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate (ORR)
Time Frame: 2 years
|
2 years
|
recommended phase 2 dose (Phase Ib)
Time Frame: At the end of Cycle 2 (each cycle is 21 days)
|
At the end of Cycle 2 (each cycle is 21 days)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS)
Time Frame: 2 years
|
2 years
|
Duration of response (DOR)
Time Frame: 2 years
|
2 years
|
ORR
Time Frame: 2 years
|
2 years
|
Progression-free survival (PFS)
Time Frame: 2 years
|
2 years
|
Disease control rate (DCR)
Time Frame: 2 years
|
2 years
|
Dose Limiting Toxicity (DLT) (Phase 1b)
Time Frame: At the end of Cycle 2 (each cycle is 21 days)
|
At the end of Cycle 2 (each cycle is 21 days)
|
Number of participants with treatment emergent adverse events (TEAEs)
Time Frame: For each participant, from the first dose till 90 days after the last dose
|
For each participant, from the first dose till 90 days after the last dose
|
Number of participants with treatment emergent serious adverse events (SAEs)
Time Frame: For each participant, from the first dose till 90 days after the last dose
|
For each participant, from the first dose till 90 days after the last dose
|
Time to response(TTR)
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Anticipated)
December 30, 2021
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
April 19, 2021
First Submitted That Met QC Criteria
April 22, 2021
First Posted (Actual)
April 23, 2021
Study Record Updates
Last Update Posted (Actual)
August 16, 2021
Last Update Submitted That Met QC Criteria
August 9, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-1701-II-207
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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