A Study of SHR-4375 in Subjects With Solid Tumors

January 21, 2025 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

An Open-label, Single-arm, Multicenter Phase I/II Clinical Study of SHR-4375 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy

This is an open-label, three-part study to evaluate the safety and efficacy of SHR-4375 for injection in subjects with solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

208

Phase

  • Phase 2
  • 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 Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Principal Investigator:
          • Xianjun Yu
        • Principal Investigator:
          • Xiaohua Wu
        • Contact:
        • Contact:

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. The subjects voluntarily joined the study and signed the ICF.
  2. Measurable disease, as defined by RECIST v1.1.
  3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
  4. Life expectancy ≥ 12 weeks.
  5. Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy.

Exclusion Criteria:

  1. Symptomatic, untreated or active central nervous system metastases.
  2. With any active autoimmune disease or history of autoimmune disease.
  3. Patients with active hepatitis B or hepatitis C.
  4. Severe infections prior to initiation of study treatment.

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: Treatment group
Drug: SHR-4375
SHR-4375 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs)
Time Frame: From Day 1 to 90 days after last dose.
From Day 1 to 90 days after last dose.
Dose limiting toxicity (DLT)
Time Frame: From Day 1 to 12 months.
From Day 1 to 12 months.
Maximal tolerable dose (MTD)
Time Frame: From Day 1 to 12 months.
From Day 1 to 12 months.
Recommended phase 2 dose (RP2D)
Time Frame: From Day 1 to 12 months.
From Day 1 to 12 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: From Day 1 to 12 months.
From Day 1 to 12 months.
Objective response rate (ORR)
Time Frame: From Day 1 to 12 months.
From Day 1 to 12 months.
Disease control rate (DCR)
Time Frame: From Day 1 to 12 months.
From Day 1 to 12 months.
Duration of response (DOR)
Time Frame: From Day 1 to 12 months.
From Day 1 to 12 months.
Overall survival (OS)
Time Frame: From Day 1 to 12 months.
From Day 1 to 12 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)

January 9, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-4375-101

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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