Clinical trial · Interventional
A Study of SHR-A1904 in Patients With Advanced Solid 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 Solid Tumors
NCT04877717CI-TRIAL-00087671active not recruitingPhase 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 advanced solid 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 Solid Cancer | Malignant Solid 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 (1)
- measure
- Determine the Maximum Tolerated Dose of SHR-A1904
- timeFrame
- up to 1 year
Secondary outcomes (5)
- measure
- Maximum concentration (Cmax)
- timeFrame
- up to 1 year
- measure
- Time to maximum concentration (Tmax)
- timeFrame
- up to 1 year
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≥ 3 months 5. Has at least one measurable lesion as defined by RECIST v1.1 6. Pathologically confirmed advanced solid cancer 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. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study 4. Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the study 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 (1)
- DERIVEDRuan DY, Wu HX, Luo SX, Huang WW, Liang XJ, Niu ZX, Dang Q, Li HL, Pan ZY, Lu HX, Zhang YQ, Li XY, Xiao XY, Cai SR, Dong YG, Zhang J, Li Z, Lan HT, Wang X, Zhou Y, Liu L, Liu HL, Xu PS, Suo AL, Jia RN, Li YQ, Peng XD, Wang SC, Yu AA, Xie J, Qiu MZ, Xu RH. The antibody-drug conjugate SHR-A1904 for targeting CLDN18.2 in advanced gastric or gastroesophageal junction cancer: a phase 1 trial. Nat Med. 2025 Sep;31(9):3037-3046. doi: 10.1038/s41591-025-03781-w. Epub 2025 Jul 16. PMID 40670772