Clinical trial · Interventional
A Trial of SHR-A1904 in Patients With Advanced Pancreatic Cancer
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
NCT04928625CI-TRIAL-00053481unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A1904 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-A1904
- interventionNames
- Drug: SHR-A1904
Primary outcomes (3)
- 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 (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.