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

Study Overview
=================
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

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

Conditions
-----------------
Advanced Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: SHR-A1904


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-Label, Single-Arm, Multi-Center Phase I Clinical Study TO EVALUATE the Safety
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-A1904<br> | Drug: SHR-A1904<br>* SHR-A1904<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |