A Trial of SHR-A1904 in Patients With Advanced Pancreatic... | NCT04928625

Studies
A Trial of SHR-A1904 in Patients With Advanced Pancreatic Cancer

NCT04928625

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Aug 24, 2021Actual

Enrollment

75Estimated

Phase

Phase 1

Conditions

Advanced Pancreatic Cancer

Interventions

SHR-A1904

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

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 6, 2021Actual

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jun 2, 2021

First Submission Date that Met QC Criteria

Jun 15, 2021

First Posted Date

Jun 16, 2021Actual

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

Aug 18, 2021

Last Update Posted Date

Aug 24, 2021Actual

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

The study is being conducted to assess the safety and tolerability of SHR-A1904 in patients with with advanced pancreatic cancer and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1904

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Label	Type	Description	Intervention Names
SHR-A1904	Experimental		Drug: SHR-A1904

Name	Type	Description	Arm Group Labels	Other Names
SHR-A1904	Drug	SHR-A1904	SHR-A1904

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose-limiting toxicity (DLT) of SHR-A1904		UP to 2 months
Maximum tolerated dose (MTD) of SHR-A1904		UP to 2 months
Recommended Phase II Dose (RP2D)		Up to 1 year

Secondary Outcomes

Measure	Description	Time Frame
Maximum concentration (Cmax)		Up to 1 year
Time to maximum concentration (Tmax)		up to 1 year
Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
Males or females aged 18-75 years old
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Has a life expectancy of ≥ 3 months
Has at least one measurable lesion as defined by RECIST v1.1

Exclusion Criteria:

Plan to receive any other anti-tumor treatments during the study treatment period of this study
Received other clinical investigational products or treatments within 4 weeks before the first dose of the study
Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the study
Previously received gastrectomy (only for subjects of the dose-escalation part)
Subjects with known brain metastases
Grade II-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the study
Presence of accompanying diseases (such as poorly controlled hypertension, serious diabetes mellitus, thyroid disorder, psychosis, etc.) that may pose serious risks to the safety of the subject or may affect the subject's ability to complete the study, or any other situation as judged by the investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chunlei Jin, Ph.D.	Contact	86-021-23511999		chunlei.jin@hengrui.com
Hao Wu	Contact	010-67166319		hao.wu.hw5@hengrui.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center	Recruiting	Shanghai	Shanghai Municipality	20000	China