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

Primary Purpose

Advanced Pancreatic Cancer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR-A1904
Sponsored by
Shanghai Hengrui Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Pancreatic Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHR-A1904

Arm Description

Outcomes

Primary Outcome Measures

Dose-limiting toxicity (DLT) of SHR-A1904
Maximum tolerated dose (MTD) of SHR-A1904
Recommended Phase II Dose (RP2D)

Secondary Outcome Measures

Maximum concentration (Cmax)
Time to maximum concentration (Tmax)
Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)
Anti-drug antibody (ADA) of SHR-A1904
Objective response rate (ORR)

Full Information

First Posted
June 2, 2021
Last Updated
August 18, 2021
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04928625
Brief Title
A Trial of SHR-A1904 in Patients With Advanced Pancreatic Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Open-Label, Single-Arm, Multi-Center Phase I Clinical Study TO EVALUATE the Safety
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHR-A1904
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR-A1904
Intervention Description
SHR-A1904
Primary Outcome Measure Information:
Title
Dose-limiting toxicity (DLT) of SHR-A1904
Time Frame
UP to 2 months
Title
Maximum tolerated dose (MTD) of SHR-A1904
Time Frame
UP to 2 months
Title
Recommended Phase II Dose (RP2D)
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Maximum concentration (Cmax)
Time Frame
Up to 1 year
Title
Time to maximum concentration (Tmax)
Time Frame
up to 1 year
Title
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
Title
Anti-drug antibody (ADA) of SHR-A1904
Time Frame
Up to 1 year
Title
Objective response rate (ORR)
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunlei Jin, Ph.D.
Phone
86-021-23511999
Email
chunlei.jin@hengrui.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Wu
Phone
010-67166319
Email
hao.wu.hw5@hengrui.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xianjun Yu, Doctor

12. IPD Sharing Statement

Learn more about this trial

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

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