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

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Contact Backup

Study Locations

  • China
    • 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:

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

Exclusion Criteria:

  1. Plan to receive any other anti-tumor treatments during the study treatment period of this study
  2. Received other clinical investigational products or treatments within 4 weeks before the first dose of the study
  3. Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the study
  4. Previously received gastrectomy (only for subjects of the dose-escalation part)
  5. Subjects with known brain metastases
  6. 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
  7. 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
Drug: 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.

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

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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