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

A Multicenter, Open-Label, Phase Ib/II 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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SHR-1701；BP102

• Study Type: Interventional
• Enrollment (Anticipated): 113
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Hao Shen; Phone Number: +0518-82342973; Email: hao.shen@hengrui.com
• Study Contact Backup: Name: Yiyuan Pan; Phone Number: 15258682523; Email: yiyuan.pan@hengrui.com

Study Locations

• China
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510060
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Contact: Ruihua Xu, Doctor; Phone Number: +86-20-87343468; Email: xurh@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR -1701 + BP102	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR)	2 years
recommended phase 2 dose (Phase Ib)	At the end of Cycle 2 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	2 years
Duration of response (DOR)	2 years
ORR	2 years
Progression-free survival (PFS)	2 years
Disease control rate (DCR)	2 years
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
Time to response(TTR)	2 years

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-1701-II-207

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No