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

NCT04856774 | Completed Phase 1

• 1 other identifier: SHR-1701-II-207
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• recommended phase 2 dose (Phase Ib)

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

• Objective response rate (ORR)

  2 years

Secondary Outcomes (9)

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

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

• Number of participants with treatment emergent adverse events (TEAEs)

  For each participant, from the first dose till 90 days after the last dose

• Number of participants with treatment emergent serious adverse events (SAEs)

  For each participant, from the first dose till 90 days after the last dose

• ORR

  2 years

• Duration of response (DOR)

  2 years

Study Arms (1)

SHR -1701 + BP102

EXPERIMENTAL

Drug: SHR-1701；BP102

Interventions

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.

SHR -1701 + BP102

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangzhou, 510060, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 23, 2021
• Study Start: June 1, 2021
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

CN (1)