NCT07231211

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for phase_1

Timeline
19mo left

Started Nov 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Nov 2025Dec 2027

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

November 20, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

November 13, 2025

Last Update Submit

January 7, 2026

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (4)

  • The Dose-Limiting Toxicity (DLT)

    Post-dose at day 1 to the end of treatment visit, about 1 year.

  • The Maximum Tolerated Dose (MTD)

    Post-dose at day 1 to the end of treatment visit, about 1 year.

  • Recommended dosage for Phase II (RP2D)

    Post-dose at day 1 to the end of treatment visit, about 1 year.

  • Incidence and severity of adverse events (AEs)

    Up to 90 days after the last administration.

Secondary Outcomes (9)

  • Objective Response Rate (ORR)

    From the first administration to the end of treatment visit, about 1 year.

  • Duration of relief (DOR)

    From the first administration to the end of treatment visit, about 1 year.

  • Disease Control Rate (DCR)

    From the first administration to the end of treatment visit, about 1 year.

  • Time to Response (TTR)

    From the first administration to the end of treatment visit, about 1 year.

  • Progression-free survival (PFS)

    From the first administration to the end of treatment visit, about 1 year.

  • +4 more secondary outcomes

Study Arms (6)

Cohort 1 Group

EXPERIMENTAL

SHR-4610 dose A in dose escalation stage.

Drug: SHR-4610 Injection

Cohort 2 Group

EXPERIMENTAL

SHR-4610 dose B in dose escalation stage.

Drug: SHR-4610 Injection

Cohort 3 Group

EXPERIMENTAL

SHR-4610 dose C in dose escalation stage.

Drug: SHR-4610 Injection

Cohort 4 Group

EXPERIMENTAL

SHR-4610 dose D in dose escalation stage.

Drug: SHR-4610 Injection

Cohort 5 Group

EXPERIMENTAL

SHR-4610 dose A/B/C/D in dose expansion stage.

Drug: SHR-4610 Injection

Cohort 6 Group

EXPERIMENTAL

SHR-4610 dose A/B/C/D in efficacy expansion stage.

Drug: SHR-4610 Injection

Interventions

SHR-4610 InjectionDRUG

SHR-4610 injection in different dose.

Cohort 1 GroupCohort 2 GroupCohort 3 GroupCohort 4 GroupCohort 5 GroupCohort 6 Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
  • Age range: 18-75 years old, both male and female are welcome;
  • 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;
  • Have at least one measurable tumor lesion per RECIST v1.1;
  • ECOG performance status of 0-1;
  • Life expectancy ≥ 12 weeks;
  • Adequate bone marrow and organ function.

You may not qualify if:

  • Patients with active central nervous system metastases or meningeal metastases;
  • Systemic antitumor therapy was received 4 weeks before the start of the study;
  • Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion;
  • Have poorly controlled or severe cardiovascular disease;
  • Subjects with active hepatitis B or active hepatitis C;
  • Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Central Study Contacts

Yunpeng Jin

CONTACT

+86-021-61053363yunpeng.jin.yj1@hengrui.com

Yuting Wang

CONTACT

+86-021-61053363yuting.wang@hengrui.com

Study Design

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

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

November 20, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations

CN(1)