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

Advanced Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04928625
• Other study ID #: SHR-A1904-I-102
• Status: Recruiting
• Phase: Phase 1
• Start date: August 6, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2021
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: Chunlei Jin, Ph.D.
• Phone: 86-021-23511999
• Email: chunlei.jin[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• SHR-A1904
SHR-A1904

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT) of SHR-A1904		UP to 2 months
Primary	Maximum tolerated dose (MTD) of SHR-A1904		UP to 2 months
Primary	Recommended Phase II Dose (RP2D)		Up to 1 year
Secondary	Maximum concentration (Cmax)		Up to 1 year
Secondary	Time to maximum concentration (Tmax)		up to 1 year
Secondary	Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)		Up to 1 year
Secondary	Anti-drug antibody (ADA) of SHR-A1904		Up to 1 year
Secondary	Objective response rate (ORR)		Up to 1 year