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

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04856774
Collaborator
(none)
113
Enrollment
1
Location
1
Arm
30.9
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
113 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SHR -1701 + BP102

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. recommended phase 2 dose (Phase Ib) [At the end of Cycle 2 (each cycle is 21 days)]

  2. Objective response rate (ORR) [2 years]

Secondary Outcome Measures

  1. Dose Limiting Toxicity (DLT) (Phase 1b) [At the end of Cycle 2 (each cycle is 21 days)]

  2. Number of participants with treatment emergent adverse events (TEAEs) [For each participant, from the first dose till 90 days after the last dose]

  3. Number of participants with treatment emergent serious adverse events (SAEs) [For each participant, from the first dose till 90 days after the last dose]

  4. ORR [2 years]

  5. Duration of response (DOR) [2 years]

  6. Disease control rate (DCR) [2 years]

  7. Time to response(TTR) [2 years]

  8. Progression-free survival (PFS) [2 years]

  9. Overall survival (OS) [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. 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)

  2. Histologically or cytologically confirmed metastatic or locally advanced solid tumors of the selected indications. (Phase II).

  3. .Life expectancy exceeds 12 weeeks;

  4. The Eastern Cancer Cooperative Group (ECOG) has a performance score of 0 or 1;

  5. Normal organ and marrow function;

Exclusion Criteria:

  1. Has known active central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are stable.

  2. A history of human immunodeficiency virus (HIV) infection is known, or has an active autoimmune disease.

  3. History of interstitial lung disease or pneumonia requiring oral or intravenous steroids.

  4. Has moderate or severe cardiovascular disease;

  5. Active HBV(hepatitis B) or HCV (Hepatitis C virus)-infected subjects;

  6. Any other malignancies within 5 years except for those with negligible risk of metastasis or death.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-sen University Cancer Center Guangzhou Guangzhou China 510060

Sponsors and Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04856774
Other Study ID Numbers:
  • SHR-1701-II-207
First Posted:
Apr 23, 2021
Last Update Posted:
Aug 16, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Aug 16, 2021