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

NCT04974957 | Unknown Phase 2

• 1 other identifier: SHR-1701-II-207-LC
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  2 years

Secondary Outcomes (4)

• Progression free survival (PFS)

  2 years

• Disease control rate (DCR)

  2 years

• Duration of response (DOR)

  2 years

• Overall survival (OS)

  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

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

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Central Study Contacts

Hao Shen

CONTACT

+0518-82342973; hao.shen@hengrui.com

You Li

CONTACT

13408501487; you.li.yl1@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 23, 2021
• Study Start: August 30, 2021
• Primary Completion: February 28, 2022
• Study Completion: August 30, 2022
• Last Updated: July 23, 2021

Record last verified: 2021-07