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

Phase 2

• Conditions: Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer
• Interventions: Drug: SHR-1701；BP102

• Registration Number: NCT04974957
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-07-16
• Last Update Submitted: 2021-07-16
• Study First Posted: 2021-07-23
• Last Update Posted: 2021-07-23
• Study Start: 2021-08-30
• Primary Completion: 2022-02-28
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-1701+BP102	SHR-1701；BP102	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	2 years

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	2 years
Duration of response (DOR)	2 years
Overall survival (OS)	2 years
Progression free survival (PFS)	2 years