A Study of SHR-4375 in Subjects With Solid Tumors

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumors

Treatments: Drug: SHR-4375

Study type: Interventional

Funder types: Industry

Identifiers

NCT06764628

SHR-4375-101

Details and patient eligibility

About

This is an open-label, three-part study to evaluate the safety and efficacy of SHR-4375 for injection in subjects with solid tumors.

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subjects voluntarily joined the study and signed the ICF.
2. Measurable disease, as defined by RECIST v1.1.
3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 12 weeks.
5. Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy.

Exclusion criteria

1. Symptomatic, untreated or active central nervous system metastases.
2. With any active autoimmune disease or history of autoimmune disease.
3. Patients with active hepatitis B or hepatitis C.
4. Severe infections 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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208 participants in 1 patient group

Treatment group

Experimental group

Treatment:

Drug: SHR-4375