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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

SHR-4610 injection in different dose.

Interventions

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SHR-4610 Injection

SHR-4610 injection in different dose.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No