Clinical trial NCT04928625: A Trial of SHR-A1904 in Patients With Advanced Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Pancreatic Cancer
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-Label, Single-Arm, Multi-Center Phase I Clinical Study TO EVALUATE the Safety
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Dose-limiting toxicity (DLT) of SHR-A1904
timeFrame: UP to 2 months
measure: Maximum tolerated dose (MTD) of SHR-A1904
timeFrame: UP to 2 months
measure: Recommended Phase II Dose (RP2D)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: Up to 1 year
measure: Time to maximum concentration (Tmax)
timeFrame: up to 1 year
measure: Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)
timeFrame: Up to 1 year
measure: Anti-drug antibody (ADA) of SHR-A1904
timeFrame: Up to 1 year
measure: Objective response rate (ORR)
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: