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

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04928625
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 28.8
• Patients Per Site Per Month: 2.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Pancreatic Cancer	Drug: SHR-A1904	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open-Label, Single-Arm, Multi-Center Phase I Clinical Study TO EVALUATE the SafetyOpen-Label, Single-Arm, Multi-Center Phase I Clinical Study TO EVALUATE the Safety
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 6, 2021
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SHR-A1904	Drug: SHR-A1904; SHR-A1904

Outcome Measures

Primary Outcome Measures

1. Dose-limiting toxicity (DLT) of SHR-A1904 [UP to 2 months]

2. Maximum tolerated dose (MTD) of SHR-A1904 [UP to 2 months]

3. Recommended Phase II Dose (RP2D) [Up to 1 year]

Secondary Outcome Measures

1. Maximum concentration (Cmax) [Up to 1 year]

2. Time to maximum concentration (Tmax) [up to 1 year]

3. Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) [Up to 1 year]

4. Anti-drug antibody (ADA) of SHR-A1904 [Up to 1 year]

5. Objective response rate (ORR) [Up to 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	20000

Sponsors and Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Hengrui Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04928625
• Other Study ID Numbers: SHR-A1904-I-102
• First Posted: Jun 16, 2021
• Last Update Posted: Aug 24, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Neoplasms

Study Results

No Results Posted as of Aug 24, 2021