Clinical trial · Interventional
A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours
An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours
NCT05508334CI-TRIAL-00099431completedPhase 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)
The purpose of this study is to allow RC88 treatment of patients with advanced solid tumours to assess the safety and tolerability of clinical pharmacology studies
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RC88 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: RC88
- description
- Subjects will receive intravenous infusion of RC88 once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs
- interventionNames
- Drug: RC88
Primary outcomes (1)
- measure
- RP2D
- timeFrame
- 28 days after first treatment
- description
- Incidence of DLT (dose limiting toxicity) of RC88
Secondary outcomes (4)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. All subjects must be ≥ 18 years at the first screening examination / visit. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. 3. Life expectancy of at least 12 weeks 4. Phase I must be histologically or cytologically confirmed and have failed standard therapy (disease progression after treatment) or are intolerant,unable to receive, or nonexistent to standard care,Patients with partial,advanced or metastatic malignant solid tumors; 5. Phase II-Advanced malignant solid tumor with MSLN expression 6. Patients with malignant pleural mesothelioma were assessed using mRECIST criteria, and those with other cancers were assessed using RECIST V1.1 criteria 7. Phase II-Mesothelin (MSLN) positive as confirmed by the central laboratory. 8. Adequate organ function 9. Voluntarily sign an informed consent form 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.