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

NCT04928625 | Unknown Phase 1

• 1 other identifier: SHR-A1904-I-102
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (3)

• 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 (5)

• 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)

  Up to 1 year

• Anti-drug antibody (ADA) of SHR-A1904

  Up to 1 year

• Objective response rate (ORR)

  Up to 1 year

Study Arms (1)

SHR-A1904

EXPERIMENTAL

Drug: SHR-A1904

Interventions

SHR-A1904 DRUG

SHR-A1904

SHR-A1904

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 20000, China

RECRUITING

Central Study Contacts

Chunlei Jin, Ph.D.

CONTACT

86-021-23511999; chunlei.jin@hengrui.com

Hao Wu

CONTACT

010-67166319; hao.wu.hw5@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label, Single-Arm, Multi-Center Phase I Clinical Study TO EVALUATE the Safety

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 16, 2021
• Study Start: August 6, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 24, 2021

Record last verified: 2021-05

Locations

CN (1)