A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors

January 7, 2026 updated by: Shanghai Shengdi Pharmaceutical Co., Ltd

An Open-label, Multicenter Phase I/II Clinical Study of SHR-4610 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy

This study is an open, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

258

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 Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Principal Investigator:
          • Xiangdong Cheng
        • 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. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
  2. Age range: 18-75 years old, both male and female are welcome;
  3. 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;
  4. Have at least one measurable tumor lesion per RECIST v1.1;
  5. ECOG performance status of 0-1;
  6. Life expectancy ≥ 12 weeks;
  7. Adequate bone marrow and organ function.

Exclusion Criteria:

  1. Patients with active central nervous system metastases or meningeal metastases;
  2. Systemic antitumor therapy was received 4 weeks before the start of the study;
  3. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion;
  4. Have poorly controlled or severe cardiovascular disease;
  5. Subjects with active hepatitis B or active hepatitis C;
  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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 Group
SHR-4610 dose A in dose escalation stage.
Drug: SHR-4610 Injection
SHR-4610 injection in different dose.
Experimental: Cohort 2 Group
SHR-4610 dose B in dose escalation stage.
Drug: SHR-4610 Injection
SHR-4610 injection in different dose.
Experimental: Cohort 3 Group
SHR-4610 dose C in dose escalation stage.
Drug: SHR-4610 Injection
SHR-4610 injection in different dose.
Experimental: Cohort 4 Group
SHR-4610 dose D in dose escalation stage.
Drug: SHR-4610 Injection
SHR-4610 injection in different dose.
Experimental: Cohort 5 Group
SHR-4610 dose A/B/C/D in dose expansion stage.
Drug: SHR-4610 Injection
SHR-4610 injection in different dose.
Experimental: Cohort 6 Group
SHR-4610 dose A/B/C/D in efficacy expansion stage.
Drug: SHR-4610 Injection
SHR-4610 injection in different dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Dose-Limiting Toxicity (DLT)
Time Frame: Post-dose at day 1 to the end of treatment visit, about 1 year.
Post-dose at day 1 to the end of treatment visit, about 1 year.
The Maximum Tolerated Dose (MTD)
Time Frame: Post-dose at day 1 to the end of treatment visit, about 1 year.
Post-dose at day 1 to the end of treatment visit, about 1 year.
Recommended dosage for Phase II (RP2D)
Time Frame: Post-dose at day 1 to the end of treatment visit, about 1 year.
Post-dose at day 1 to the end of treatment visit, about 1 year.
Incidence and severity of adverse events (AEs)
Time Frame: Up to 90 days after the last administration.
Up to 90 days after the last administration.

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: From the first administration to the end of treatment visit, about 1 year.
From the first administration to the end of treatment visit, about 1 year.
Duration of relief (DOR)
Time Frame: From the first administration to the end of treatment visit, about 1 year.
From the first administration to the end of treatment visit, about 1 year.
Disease Control Rate (DCR)
Time Frame: From the first administration to the end of treatment visit, about 1 year.
From the first administration to the end of treatment visit, about 1 year.
Time to Response (TTR)
Time Frame: From the first administration to the end of treatment visit, about 1 year.
From the first administration to the end of treatment visit, about 1 year.
Progression-free survival (PFS)
Time Frame: From the first administration to the end of treatment visit, about 1 year.
From the first administration to the end of treatment visit, about 1 year.
Time to the maximum plasma concentration (Tmax)
Time Frame: From Day 1 pre-dose to 30 days after the last administration.
From Day 1 pre-dose to 30 days after the last administration.
Maximum concentration of SHR-4610 (Cmax)
Time Frame: From Day 1 pre-dose to 30 days after the last administration.
From Day 1 pre-dose to 30 days after the last administration.
SHR-4610 serum trough concentration (Ctrough)
Time Frame: From Day 1 pre-dose to 30 days after the last administration.
From Day 1 pre-dose to 30 days after the last administration.
Area under the concentration versus time curve of SHR-4610 from time zero to time t (AUC0-t)
Time Frame: From Day 1 pre-dose to 30 days after the last administration.
From Day 1 pre-dose to 30 days after the last administration.

Collaborators and Investigators

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

Sponsor

Shanghai Shengdi Pharmaceutical 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)

November 20, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Estimated)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SHR-4610-101

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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