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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04974957

Enrollment

Registered

2021-07-23

Start date

2021-08-30

Completion date

2022-08-30

Last updated

2021-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGSHR-1701；BP102

Drug: SHR-1701 IV infusion Drug: BP102 IV infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR)	2 years

Secondary

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

Contacts

Primary ContactHao Shen

hao.shen@hengrui.com+0518-82342973

Backup ContactYou Li

you.li.yl1@hengrui.com13408501487

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026