A Study of SHR-4375 in Subjects With Solid Tumors | NCT06764628

Studies
A Study of SHR-4375 in Subjects With Solid Tumors

NCT06764628

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Status

Recruiting

Last Update Posted

Jan 22, 2025Actual

Enrollment

208Estimated

Phase

Phase 1Phase 2

Conditions

Solid Tumors

Interventions

SHR-4375

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 9, 2025Actual

Primary Completion Date

May 2027Estimated

Completion Date

May 2027Estimated

First Submitted Date

Jan 2, 2025

First Submission Date that Met QC Criteria

Jan 2, 2025

First Posted Date

Jan 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2025

Last Update Posted Date

Jan 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

208Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental		Drug: SHR-4375

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHR-4375	Drug	SHR-4375 injection	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Progression free survival (PFS)		From Day 1 to 12 months.
Objective response rate (ORR)		From Day 1 to 12 months.
Disease control rate (DCR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuanchao Wang	Contact	0518-82342973		yuanchao.wang@hengrui.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center	Recruiting	Shanghai	Shanghai Municipality	200032	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided