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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Unknown; Phase 2

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

Treatments: Drug: SHR-1701；BP102

Study type: Interventional

Funder types: Industry

Identifiers

NCT04974957

SHR-1701-II-207-LC

Details and patient eligibility

About

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.

Enrollment: 71 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.
11. Active tuberculosis within one year prior to initiation of study treatment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

SHR-1701+BP102

Experimental group

Treatment:

Drug: SHR-1701；BP102