Clinical trial · Interventional
A Study of HRS2543 in Patients With Advanced Tumors
A Phase I, Multi-Center, Open Label, Dose Escalation/Expansion Study of HRS2543 in Patients With Advanced Tumors
NCT05068856CI-TRIAL-00078934terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): R\&d strategy adjustment
Summary
Brief summary (as posted)
To assess the safety and tolerability of HRS2543 in patients with advanced tumors and to determine the recommended phase II dose (RP2D) of HRS2543
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 Tumors | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS2543 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HRS2543
- interventionNames
- Drug: HRS2543
Primary outcomes (3)
- measure
- Dose-Limiting Toxicity (DLT)
- timeFrame
- Day 1 to 28 (Cycle 1)
- description
- A DLT is considered at AE related to study drug unless there is a clear, well-documented, alternative explanation for the toxicity. Severity of AEs are graded according to the NCI CTCAE 5.0 for the study, the occurrence of the following drug related AEs during the single dose and the first cycle (28 days) will be considered a DLT by the investigator and SMC.
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- Day 1 to 28 (Cycle 1)
- description
- Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18-70 years of age, both male and female 2. non standard treatment, invalid the standard treatment or refuse to receive standard treatment in patients with advanced tumors diagnosed by pathology 3. the Eastern Cooperative Oncology Group （ECOG） General status (performance status, PS) of 0-1 4. the expected lifetime ≥ 3 months 5. Has at least one measurable lesion as defined by RECIST v1.1 6. Written informed consent is provided by signing the informed consent form Exclusion Criteria: 1. Any previous anti-tumor treatment 2. The toxicity caused by any previous anti-tumor treatment has not recovered to ≤ grade 1 3. Any other anti-tumor treatment is planned during the study treatment 4. After imaging diagnosis, there were brain tumor lesions 5. According to the judgment of the researcher, there are factors that can not swallow, chronic diarrhea and intestinal obstruction or other factors that can significantly affect the absorption, distribution, metabolism or excretion of drugs 6. Active heart disease was present within 6 months before the first administration of the study 7. Other malignancies occurred within 5 years before the first administration of the study 8. Active HBV or HCV infection 9. The subject had a history of immune deficiency 10. According to the judgment of the researcher, there are concomitant diseases that seriously endanger the safety of the subjects, confuse the analysis of the test results, or affect the subjects to complete the study
References
Publications (0)
Data not yet available
No reference posted for this study.