Clinical trial · Interventional
CT-95 in Advanced Cancers Associated With Mesothelin Expression
Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression
NCT06756035CI-TRIAL-00114665recruitingPhase 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 Phase 1a/1b, first-in-human (FIH), open-label, multi-center dose escalation and expansion study of the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of single-agent CT-95 in subjects with advanced (recurrent, unresectable, or metastatic) cancers associated with MSLN expression.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma Advanced | — | UNRESOLVED | — |
| Cholangiocarcinoma Non-resectable | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Lung Adenocarcinoma Metastatic | — | UNRESOLVED | — |
| Malignant Peritoneal Mesothelioma, Advanced | Peritoneal Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Malignant Pleural Mesothelioma, Advanced | Pleural Malignant Mesothelioma | CURATED_BROADER | 0.78 |
| Mesothelin-expressing Advanced Cancers | — | UNRESOLVED | — |
| Mesothelin-Expressing Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-95 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CT-95
- description
- Phase 1a: Dose Escalation - each dose cohort will assess toxicity 28 days following the first dose of CT95 anticipate a total of 8 dose cohorts. Phase 1b: Dose Expansion - approximately 80 participants will be evaluated in 2-4 indication-specific expansion cohorts.
- interventionNames
- Drug: CT-95
Primary outcomes (2)
- measure
- Determine the MTD or RD of CT-95 [Safety and Tolerability]
- timeFrame
- From date of first dose of CT-95 until 28 days following the first dose.
- description
- The frequency of dose-limiting toxicities (DLTs) will be analyzed along with safety and tolerability measures to determine the MTD or RD of CT-95.
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG 0 or 1 * Subjects with evaluable disease per RECIST 1.1 or mRECIST * Subjects with adequate organ function. * Subjects with advanced cancers associated with mesothelin expression Exclusion Criteria: * Uncontrolled significant active infection or any medical or other condition that in opinion of the investigator would preclude the subject's participation in the study. * Prior treatment with MSLN-targeted CD3 or chimeric antigen receptor T cell (CAR-T) therapy * Concurrent participation in another investigational clinical trial. * Evidence of leptomeningeal disease
References
Publications (0)
Data not yet available
No reference posted for this study.