Clinical trial · Interventional
A Study of SHR-4375 in Subjects With Solid Tumors
An Open-label, Single-arm, Multicenter Phase I/II Clinical Study of SHR-4375 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy
NCT06764628CI-TRIAL-00084956recruitingPhase 1 / Phase 2ClinicalTrials.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, three-part study to evaluate the safety and efficacy of SHR-4375 for injection in subjects with solid tumors.
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-4375 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- interventionNames
- Drug: SHR-4375
Primary outcomes (4)
- measure
- Adverse events (AEs)
- timeFrame
- From Day 1 to 90 days after last dose.
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- From Day 1 to 12 months.
- measure
- Maximal tolerable dose (MTD)
- timeFrame
- From Day 1 to 12 months.
- measure
- Recommended phase 2 dose (RP2D)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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: 1. Symptomatic, untreated or active central nervous system metastases. 2. With any active autoimmune disease or history of autoimmune disease. 3. Patients with active hepatitis B or hepatitis C. 4. Severe infections prior to initiation of study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.