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

A Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications

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.

This is a Phase I, open-label, multiple-ascending dose trial. Study consists of dose-escalation part in subjects with metastatic or locally advanced solid tumors, and expansion part with selected indications.

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