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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SHR-7631

• Registration Number: NCT06381050
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-19
• Study First Posted: 2024-04-24
• Study Start: 2024-05-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2026-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-7631	SHR-7631	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0)	36 months
Maximum tolerated dose (MTD) or maximum administered dose (MAD)	12 months

Secondary Outcome Measures

Name	Time	Method
PK parameter: t1/2	36 months
PK parameter: Tmax	36 months
PK parameter: Cmax	36 months
PK parameter: AUC0-t	36 months
PK parameter: AUC0-∞	36 months
PK parameter: MRT (mean residence time)	36 months

Trial Locations

Locations (2)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangzhou, China