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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04856774
• Other study ID #: SHR-1701-II-207
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2021
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Hao Shen
• Phone: +0518-82342973
• Email: hao.shen[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 113
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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