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

Hengrui Medicine

Status and phase

Active, not recruiting

Phase 1

Conditions

Solid Tumor

Treatments

Drug: SHR-1701

Study type

Interventional

Funder types

Industry

Identifiers

NCT03774979

SHR-1701-I-102

Details and patient eligibility

About

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.

Full description

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.

Enrollment

193 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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