CT-95 in Advanced Cancers Associated With Mesothelin Expression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT-95.
- Who it may be relevant to
- Registry conditions: Mesothelin-Expressing Tumors, Epithelial Ovarian Cancer, Malignant Pleural Mesothelioma, Advanced, Malignant Peritoneal Mesothelioma, Advanced. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression
Overview
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.
Detailed description
Phase 1a Dose Escalation: Participants with ovarian epithelial tumors, primary peritoneal or fallopian tube cancer (PROC), epithelioid mesothelioma, lung adenocarcinoma, pancreatic adenocarcinoma, colorectal cancer, cholangiocarcinoma, and gastric/GEJ adenocarcinomas will be enrolled in one of approximately 9 dose escalation cohorts to assess the safety and tolerability of CT-95, as well as determine the maximum tolerated dose (MTD) or other recommended dose(s) for expansion (RDE\[s\]) for further dose expansion cohorts.
Participants will receive CT-95 as a single agent administered once weekly (QW) intravenously (IV) over a 4-week cycle.
Phase 1b Dose Expansion: The RDE(s) of CT-95 determined in Phase 1a will be evaluated in 2-4 indication-specific expansion cohorts of up to 20 subjects each (i.e. up to 80 participants total). Different indications, dose levels, and/or schedules may be explored. The expansion doses and/or dosing schedules for Phase 1b will be determined by Sponsor in conjunction with SRC based upon all available safety, PK, PD, biomarker, and preliminary efficacy data from Phase 1a.
Interventions
- Drug CT-95
MSLN bispecific antibody to be administered according to the dose and schedule of the assigned cohort until documentation of disease progression (or confirmed disease progression), unacceptable toxicity, or participant/physician decision.
Primary outcome measures
- Determine the MTD or RD of CT-95 [Safety and Tolerability] [Time frame: From date of first dose of CT-95 until 28 days following the first dose.]
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.]
Secondary outcome measures (6)
- Evaluate Response Rates [Anti-tumor Activity] [Time frame: At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first]
- Evaluate Progression-free Survival [Anti-tumor Activity] [Time frame: At 8-week intervals from the time of the first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.]
- Evaluate Overall Survival [Survival] [Time frame: From the time of the first dose of CT-95 until approximately two years post-first dose.]
- Evaluate the Maximum Serum Concentration (Cmax) [Pharmacokinetics] [Time frame: From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.]
- Evaluate the Area Under the Curve (AUC) [Pharmacokinetics] [Time frame: From date of first dose of CT-95 for 5 months or treatment discontinuation, whichever comes first.]
- Evaluate Anti-Drug Antibodies [Immunogenicity] [Time frame: From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Context Investigational Site — Denver
- Context Investigational Site — Chicago
- Context Investigational Site — Grand Rapids
- Context Investigational Site — Hackensack
- University of Pennsylvania — Philadelphia
- Context Investigational Site — Philadelphia
- Context Investigational Site — Nashville
- Context Investigational Site — San Antonio
- … and 1 more center
Identifiers
NCT: NCT06756035 · CNTX-CT95-101