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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: SHR-1701；BP102

Study type: Interventional

Funder types: Industry

Identifiers

NCT04856774

SHR-1701-II-207

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

SHR -1701 + BP102

Experimental group

Treatment:

Drug: SHR-1701；BP102