Clinical trial · Interventional
A Trial of SHR-7367 in Subjects With Advanced Solid Tumors
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of SHR-7367 in Subjects With Advanced Solid Tumors
NCT05740202CI-TRIAL-00118234completedPhase 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 a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects with advanced 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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-7367 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-7367
- interventionNames
- Drug: SHR-7367
Primary outcomes (3)
- measure
- Dose-limiting toxicities (DLTs)
- timeFrame
- Up to 3 weeks
- description
- Number of participants with DLTs
- measure
- Recommended phase II dose
- timeFrame
- first dose of study medication up to 21 days
- description
- The Recommended phase II dose of SHR-7367 injection
- measure
- Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study; 2. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF; 3. Histopathologically or cytologically documented advanced or metastatic malignancies; 4. At least 1 measurable lesion conforming to RECIST 1.1 criteria; 5. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 6. Female and male patients of reproductive potential must agree to use highly effective contraception. Exclusion Criteria: 1. Any immunostimulants administered within 4 weeks; 2. Systemic anti-tumor therapy within 4 weeks; 3. Any investigational cancer therapy administered within 4 weeks; 4. Surgical procedures requiring general anesthesia within 4 weeks; 5. History of autoimmune diseases; 6. History of immunodeficiency; 7. Severe infections within 2 weeks prior to the first study treatment; 8. Clinically significant cardiovascular condition; 9. Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment; 10. Known history of serious allergic reactions to the investigational product or its main ingredients.
References
Publications (0)
Data not yet available
No reference posted for this study.