The Clinical Study of SHR-7631 for Injection in Patients With Advanced Solid Tumors

NCT ID: NCT06381050

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-24
• Study Completion Date: 2025-03-21

Brief Summary

This study is an open-label, phase I clinical trial of SHR-7631 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-7631

Group Type: EXPERIMENTAL

SHR-7631

Intervention Type: DRUG

The total dosage of SHR-7631 was calculated according to the weight weighing results of the subjects before each administration, and was administered by intravenous drip.

Interventions

SHR-7631

The total dosage of SHR-7631 was calculated according to the weight weighing results of the subjects before each administration, and was administered by intravenous drip.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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, or standard treatment is not applicable currently;

2. Have at least one measurable tumor lesion per RECIST v1.1 (subject with only non-target tumor lesion will be permitted if he/she is planned to participant in dose escalation stage or with mCRPC);

3. ECOG performance status of 0-1;

4. Life expectancy ≥ 12 weeks;

5. Adequate bone marrow and organ function

6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

7. Age 18 to 75 years old (including both ends), gender is not limited;

Exclusion Criteria

1. Patients with active central nervous system metastases or meningeal metastases;

2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;

3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;

4. History of serious cardiovascular and cerebrovascular diseases;

5. Severe infection within 4 weeks prior to the first dose;

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

Sponsors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangzhou, China

Countries

China

Other Identifiers

SHR-7631-101

Identifier Type: -

Identifier Source: org_study_id