Clinical trial · Interventional
A Study of SHR-A1909 in Subjects With Advanced Malignant Tumors
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-1909 Injection in Patients With Advanced Malignant Tumors
NCT05162469CI-TRIAL-00092670completedPhase 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, multi-center, three-part phase I trial to evaluate the safety, pharmacokinetics and immunogenicity of SHR-1909 and preliminary anti-tumor efficacy of SHR-1909 in advanced malignant cancer.
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 Malignant Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1909 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1909 monotherapy
- interventionNames
- Drug: SHR-1909 injection
Primary outcomes (2)
- measure
- MTD of SHR-1909
- timeFrame
- From Day 1 to 4 weeks
- description
- Maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs)
- measure
- RP2D of SHR-1909
- timeFrame
- From Day 1 to 90 days after last dose
- description
- Recommended Phase 2 Dose(RP2D) of SHR-1909 will be determined during the dose-escalation and dose-expansion parts of the study. RP2D will be determined using available safety, pharmacokinetics and pharmacodynamics data.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Patients must have cytologically or histologically confirmed advanced malignant tumor, and must have failed standard treatment; * Toxicities caused by prior anti-tumor treatments must have resolved to CTCAE Grade ≤ 1 prior to the first dose (except for alopecia or hypothyroidism treated with hormone replacement therapy or diabetes controlled with insulin); * Adequate organ function. Exclusion Criteria: * With CNS infiltration, or ascites requiring paracentesis or symptomatic pleural effusion; * Received prior CAR T-cell therapy; * Received allogeneic hematopoietic stem cell transplantation within 3 months prior to the start of study treatment, or with acute/chronic graft versus host disease; * With active infection or fever of unknown origin (\> 38.5 °C).
References
Publications (0)
Data not yet available
No reference posted for this study.