Skip to main content
OpenTrials
Completed

NCT Number: NCT04856774

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Solid Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-1701；BP102

Drug

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.

Primary outcomes

  1. recommended phase 2 dose (Phase Ib)

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

  2. Objective response rate (ORR)

    Time frame: 2 years

Secondary outcomes

  1. Dose Limiting Toxicity (DLT) (Phase 1b)

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

  2. 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

  3. 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

  4. ORR

    Time frame: 2 years

  5. Duration of response (DOR)

    Time frame: 2 years

  6. Disease control rate (DCR)

    Time frame: 2 years

  7. Time to response(TTR)

    Time frame: 2 years

  8. Progression-free survival (PFS)

    Time frame: 2 years

  9. Overall survival (OS)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 23, 2021
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.