NCT06764628

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for phase_1

Timeline
11mo left

Started Jan 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 Progress59%
Jan 2025May 2027

First Submitted

Initial submission to the registry

January 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

January 9, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

2.3 years

First QC Date

January 2, 2025

Last Update Submit

January 21, 2025

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (4)

  • Adverse events (AEs)

    From Day 1 to 90 days after last dose.

  • Dose limiting toxicity (DLT)

    From Day 1 to 12 months.

  • Maximal tolerable dose (MTD)

    From Day 1 to 12 months.

  • Recommended phase 2 dose (RP2D)

    From Day 1 to 12 months.

Secondary Outcomes (5)

  • Progression free survival (PFS)

    From Day 1 to 12 months.

  • Objective response rate (ORR)

    From Day 1 to 12 months.

  • Disease control rate (DCR)

    From Day 1 to 12 months.

  • Duration of response (DOR)

    From Day 1 to 12 months.

  • Overall survival (OS)

    From Day 1 to 12 months.

Study Arms (1)

Treatment group

EXPERIMENTAL
Drug: SHR-4375

Interventions

SHR-4375DRUG

SHR-4375 injection

Treatment group

Eligibility Criteria

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

You may qualify if:

  • The subjects voluntarily joined the study and signed the ICF.
  • Measurable disease, as defined by RECIST v1.1.
  • The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 12 weeks.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Yuanchao Wang

CONTACT

0518-82342973yuanchao.wang@hengrui.com

Study Design

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

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 8, 2025

Study Start

January 9, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

January 22, 2025

Record last verified: 2025-01

Locations

CN(1)