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

July 16, 2021 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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,efficacy and pharmacokinetic when combining SHR-1701 and BP102 in participants with advanced or metastatic non-squamous non-small cell lung cancer. To explore the immunogenicity of SHR-1701 and the relationship between corresponding biomarkers and therapeutic effect.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 advanced or metastatic non-squamous non-small cell lung cancer.
  2. Failed with prior systemic treatments.
  3. Measurable disease, as defined by RECIST v1.1
  4. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
  5. Life expectancy ≥ 3 months
  6. Adequate hematologic and end-organ function as defined in the protocol

Exclusion Criteria:

  1. Histologically or cytologically confirmed mixed SCLC and NSCLC.
  2. Symptomatic, untreated or active central nervous system metastases.
  3. Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment
  4. With any active autoimmune disease or history of autoimmune disease.
  5. Inadequately controlled hypertension.
  6. Tumor infiltration into the great vessels on imaging.
  7. History of hemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.
  8. Uncontrolled tumor-related pain.
  9. Patients with active hepatitis B or hepatitis C
  10. Severe infections within 4 weeks prior to initiation of study treatment.
  11. Active tuberculosis within one year prior to initiation of study treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 30, 2021

Primary Completion (Anticipated)

February 28, 2022

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

July 16, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-1701-II-207-LC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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