Clinical trial · Interventional
A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours
An Open-label, Non-randomised, Multi-center Study to Evaluate the Safety， and Efficacy Off RC88 Combined With Sintilimab in AdvancedSolid Tumours
NCT05804526CI-TRIAL-00076601unknownPhase 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 study will evaluate safety , clinical pharmacology and efficacy of intravenous RC88 combined with Sintilimab in advancedsolid tumours
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 Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RC88 | Drug | — | UNRESOLVED |
| Sintilimab Injection | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RC88+Sintilimab Injection
- description
- RC88+Sintilimab Injection Arm
- interventionNames
- Drug: RC88
- Drug: Sintilimab Injection
Primary outcomes (1)
- measure
- RP2D
- timeFrame
- 28 days after first treatment
- description
- Incidence of DLT (dose limiting toxicity) of RC88 combined with Sintilimab
Secondary outcomes (3)
- measure
- ORR
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntary agreement to provide written informed consen 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 3. Predicted survival ≥ 12 weeks 4. Phase I (Phase I) was included and confirmed as MSLN positive (≥1+ after IHC test by central laboratory).Failure, intolerance, or lack of standard treatment has been identified by tissue or cytology The MSLN test is not required for patients with advanced malignant tumor and for subjects diagnosed with malignant mesothelioma; 5. Adequate organ function required 6. Male and female participants are eligible to participate if they agree to the contraception use as per study protocol. Exclusion Criteria: 1. Cancer metastases in the brain 2. Active infection or past hepatitis B or C infection 3. Major surgery less than 1 month before the start of the study 4. Uncontrolled heart disease 5. History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds
References
Publications (0)
Data not yet available
No reference posted for this study.