Clinical trial · Interventional
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
NCT04446260CI-TRIAL-00095124completedPhase 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)
This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A1811 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1 Dose escalation
- interventionNames
- Drug: SHR-A1811
- type
- EXPERIMENTAL
- label
- Part 2 PK expansion
- interventionNames
- Drug: SHR-A1811
- type
- EXPERIMENTAL
- label
- Part 3 Indication expansion
- interventionNames
- Drug: SHR-A1811
Primary outcomes (1)
- measure
- Incidence and severity of adverse events (AEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * LVEF ≥ 50% by either ECHO or MUGA * Has adequate renal and hepatic function * Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment Exclusion Criteria: * History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period * Known hereditary or acquired bleeding and thrombotic tendency
References
Publications (1)
- DERIVEDYao H, Yan M, Tong Z, Wu X, Ryu MH, Park JJ, Kim JH, Zhong Y, Zhao Y, Voskoboynik M, Yin Y, Liu K, Kaubisch A, Liu C, Zhang J, Wang S, Im SA, Ganju V, Barve M, Li H, Ye C, Roy AC, Bai LY, Yen CJ, Gu S, Lin YC, Wu L, Bao L, Zhao K, Shen Y, Rong S, Zhu X, Song E. Safety, Efficacy, and Pharmacokinetics of SHR-A1811, a Human Epidermal Growth Factor Receptor 2-Directed Antibody-Drug Conjugate, in Human Epidermal Growth Factor Receptor 2-Expressing or Mutated Advanced Solid Tumors: A Global Phase I Trial. J Clin Oncol. 2024 Oct 10;42(29):3453-3465. doi: 10.1200/JCO.23.02044. Epub 2024 Jun 20. PMID 38900984