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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: SHR-7631

Study type: Interventional

Funder types: Industry

Identifiers

NCT06381050

SHR-7631-101

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

SHR-7631

Experimental group

Treatment:

Drug: SHR-7631