SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to assess the safety and tolerability of SHR-1701 at different dose levels. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

• Able and willing to provide signed informed consent form, and able to comply with all procedures.

• Histologically or cytologically proven metastatic or locally advanced solid tumors.

• Male or female subjects aged 18-75 years.

• Life expectancy >= 12 weeks as judged by the Investigator.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.

• Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

• Adequate hematological, hepatic and renal function as defined in the protocol

Other protocol-defined inclusion criteria could apply.

Exclusion Criteria:

• Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.

• Anticancer treatment within 28 days before the first dose of study drug.

• Major surgery within 28 days before start of trial treatment.

• Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.

• With any active autoimmune disease or history of autoimmune disease.

• With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.

• Clinically significant cardiovascular and cerebrovascular diseases

• History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.

• Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.

• Receipt of any organ transplantation, including allogeneic stem-cell transplantation

Other protocol-defined exclusion criteria could apply