- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04928625
A Trial of SHR-A1904 in Patients With Advanced Pancreatic Cancer
August 18, 2021 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.
An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Pancreatic Cancer
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
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
75
Phase
- 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
- Name: Chunlei Jin, Ph.D.
- Phone Number: 86-021-23511999
- Email: chunlei.jin@hengrui.com
Study Contact Backup
- Name: Hao Wu
- Phone Number: 010-67166319
- Email: hao.wu.hw5@hengrui.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 20000
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- xianjun Yu, Doctor
-
-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHR-A1904
|
SHR-A1904
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose-limiting toxicity (DLT) of SHR-A1904
Time Frame: UP to 2 months
|
UP to 2 months
|
Maximum tolerated dose (MTD) of SHR-A1904
Time Frame: UP to 2 months
|
UP to 2 months
|
Recommended Phase II Dose (RP2D)
Time Frame: Up to 1 year
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to maximum concentration (Tmax)
Time Frame: up to 1 year
|
up to 1 year
|
Maximum concentration (Cmax)
Time Frame: Up to 1 year
|
Up to 1 year
|
Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)
Time Frame: Up to 1 year
|
Up to 1 year
|
Anti-drug antibody (ADA) of SHR-A1904
Time Frame: Up to 1 year
|
Up to 1 year
|
Objective response rate (ORR)
Time Frame: Up to 1 year
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
August 6, 2021
Primary Completion (Anticipated)
June 30, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
June 2, 2021
First Submitted That Met QC Criteria
June 15, 2021
First Posted (Actual)
June 16, 2021
Study Record Updates
Last Update Posted (Actual)
August 24, 2021
Last Update Submitted That Met QC Criteria
August 18, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-A1904-I-102
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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