NCT04928625UnknownPhase 1
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
Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country75 target enrollmentStarted: August 6, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Dose-limiting toxicity (DLT) of SHR-A1904
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SHR-A1904
Experimental
Intervention: SHR-A1904 (Drug)
Outcomes
Primary Outcomes
Dose-limiting toxicity (DLT) of SHR-A1904
Time Frame: UP to 2 months
Maximum tolerated dose (MTD) of SHR-A1904
Time Frame: UP to 2 months
Recommended Phase II Dose (RP2D)
Time Frame: Up to 1 year
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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