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

June 12, 2025 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 12 months
12 months
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0)
Time Frame: 36 months
36 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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