CompletedPhase 1/2

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

China81 participantsStarted 2021-06-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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.

What they're measuring

recommended phase 2 dose (Phase Ib)

Timeframe: At the end of Cycle 2 (each cycle is 21 days)

Objective response rate (ORR)

Timeframe: 2 years

Trial details

NCT IDNCT04856774

SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-30

View on ClinicalTrials.gov More Advanced Solid Tumors trials