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

Phase 1

• Conditions: Advanced Pancreatic Cancer
• Interventions: Drug: SHR-A1904

• Registration Number: NCT04928625
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-16
• Study Start: 2021-08-06
• Last Update Submitted: 2021-08-18
• Last Update Posted: 2021-08-24
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-A1904	SHR-A1904	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to maximum concentration (Tmax)	up to 1 year
Maximum concentration (Cmax)	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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China