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

NCT06381050 | Completed Phase 1

• 1 other identifier: SHR-7631-101
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) or maximum administered dose (MAD)

  12 months

• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0)

  36 months

Secondary Outcomes (6)

• PK parameter: Tmax

  36 months

• PK parameter: Cmax

  36 months

• PK parameter: AUC0-t

  36 months

• PK parameter: AUC0-∞

  36 months

• PK parameter: t1/2

  36 months

Study Arms (1)

SHR-7631

EXPERIMENTAL

Drug: SHR-7631

Interventions

SHR-7631 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.

SHR-7631

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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);
• ECOG performance status of 0-1;
• Life expectancy ≥ 12 weeks;
• Adequate bone marrow and organ function
• Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
• Age 18 to 75 years old (including both ends), gender is not limited;

You may not qualify if:

• Patients with active central nervous system metastases or meningeal metastases;
• Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
• Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;
• History of serious cardiovascular and cerebrovascular diseases;
• Severe infection within 4 weeks prior to the first dose;
• Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (2)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangzhou, 510062, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: May 24, 2024
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

CN (2)