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

An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7631 for Injection in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SHR-7631

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Peking University Cancer Hospital
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510062
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-7631	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
PK parameter: MRT (mean residence time)	36 months

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Actual): March 21, 2025
• Study Completion (Actual): March 21, 2025

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-7631-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No