Clinical trial · Interventional
A Clinical Study of SHR-4595 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability and Pharmacokinetics
An Open-label, Multicenter Phase I Clinical Study of SHR-4595 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability and Pharmacokinetics
NCT07830199CI-TRIAL-00126483not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The study is being conducted to evaluate the safety and tolerability of SHR-4595 for injection in participants with advanced solid tumors, and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose for Phase II clinical studies (RP2D) of SHR-4595.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-4595 for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-4595 Group
- description
- SHR-4595 for Injection, in different stages with different doses.
- interventionNames
- Drug: SHR-4595 for Injection
Primary outcomes (4)
- measure
- Adverse events (AEs)
- timeFrame
- From Day 1 to 40 days after last dose.
- description
- Safety endpoints.
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- From Day 1 to 12 months.
- description
- Safety endpoints.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: A subject must satisfy all of the following criteria to be considered for inclusion in the study. 1. The subjects voluntarily joined the study and signed the ICF. 2. Measurable disease, as defined by RECIST v1.1. 3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1. 4. Life expectancy ≥ 12 weeks. 5. Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy. Exclusion Criteria: A subject who meets any of the following criteria will be excluded from study entry. 1. Symptomatic, untreated or active central nervous system metastases. 2. Have uncontrolled or severe cardiovascular disease Have clinical symptoms or disease of the heart that are not well controlled. 3. With any active autoimmune disease or history of autoimmune disease. 4. Patients with active hepatitis B or hepatitis C. 5. Severe infections prior to initiation of study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.