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Study of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Study 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

NCT04974957•Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Key Dates

Start Date

August 30, 2021

Primary Completion Date

February 28, 2022

Completion Date

August 30, 2022

Last Updated

July 23, 2021

Enrollment

ESTIMATED participants

Conditions

Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer

Interventions

SHR-1701；BP102

DRUG

Contacts

Hao Shen

CONTACT

+0518-82342973 hao.shen@hengrui.com

You Li

CONTACT

13408501487 you.li.yl1@hengrui.com

A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

NCT06311721

Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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