A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors

Shanghai Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumors

Treatments: Drug: SHR-4610 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07231211

SHR-4610-101

Details and patient eligibility

About

This study is an open, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.

Enrollment: 258 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
2. Age range: 18-75 years old, both male and female are welcome;
3. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment;
4. Have at least one measurable tumor lesion per RECIST v1.1;
5. ECOG performance status of 0-1;
6. Life expectancy ≥ 12 weeks;
7. Adequate bone marrow and organ function.

Exclusion criteria

1. Patients with active central nervous system metastases or meningeal metastases;
2. Systemic antitumor therapy was received 4 weeks before the start of the study;
3. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion;
4. Have poorly controlled or severe cardiovascular disease;
5. Subjects with active hepatitis B or active hepatitis C;
6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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258 participants in 6 patient groups

Cohort 1 Group

Experimental group

Description:

SHR-4610 dose A in dose escalation stage.

Treatment:

Drug: SHR-4610 Injection

Cohort 2 Group

Experimental group

Description:

SHR-4610 dose B in dose escalation stage.

Treatment:

Drug: SHR-4610 Injection

Cohort 3 Group

Experimental group

Description:

SHR-4610 dose C in dose escalation stage.

Treatment:

Drug: SHR-4610 Injection

Cohort 4 Group

Experimental group

Description:

SHR-4610 dose D in dose escalation stage.

Treatment:

Drug: SHR-4610 Injection

Cohort 5 Group

Experimental group

Description:

SHR-4610 dose A/B/C/D in dose expansion stage.

Treatment:

Drug: SHR-4610 Injection

Cohort 6 Group

Experimental group

Description:

SHR-4610 dose A/B/C/D in efficacy expansion stage.

Treatment:

Drug: SHR-4610 Injection