Clinical trial · Interventional
Phase I/II Clinical Trials of SHR-8203 Injection in Participants With Advanced Solid Tumors
An Open-label, Multi-center Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-8203 Injection in Participants With Advanced Solid Tumors
NCT07769242CI-TRIAL-00122344not yet recruitingPhase 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 trial is a multicenter, open-label Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and efficacy of SHR-8203 injection in participants 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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-8203 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-8203 Injection
- interventionNames
- Drug: SHR-8203 Injection
Primary outcomes (5)
- measure
- The number of subjects with dose-limiting toxicity (DLT)
- timeFrame
- From first dose of study treatment until the end of Cycle 1（up to 21 days）
- measure
- Incidence and severity of AEs
- timeFrame
- From the first visit to the end of the safety follow-up period (1 year)
- measure
- Maximum Tolerated Dose
- timeFrame
- During the DLT observation period, the dose level at which the estimated toxicity probability was closest to the target toxicity probability (i.e., 0.3)（up to 21 days）
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 and 75 years old, gender not limited; 2. Be willing to participate and abide by the requirements of the research protocol, and be willing to cooperate with the follow-up. 3. Participants with advanced or metastatic solid tumors confirmed by histological or cytological pathology who have failed standard treatment (disease progression or toxic intolerance) or have no effective standard treatment; 4. Able to provide sufficient fresh or archived tumor tissue specimens for the third-party central laboratory designated by the sponsor. 5. Have at least one measurable lesion as per RECIST v1.1; 6. ECOG PS score: 0-1; 7. Good organ function level. Exclusion Criteria: 1. Imaging studies show that the tumor invades major blood vessels or has an unclear boundary with blood vessels, and researchers determine that there is a risk of massive hemorrhage; 2. Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment; 3. Pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, poorly controlled, or moderate to severe; 4. Major arterial or venous thrombosis events occurred within 6 months before the first administration of medication; 5. Participants who have experienced severe infections within one month prior to the first medication.
References
Publications (0)
Data not yet available
No reference posted for this study.