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2025-03-31
2026-12
2028-12
70
NCT06756035
Context Therapeutics Inc.
Context Therapeutics Inc.
INTERVENTIONAL
CT-95 in Advanced Cancers Associated With Mesothelin Expression
This is a Phase 1a/1b open-label, dose escalation study to evaluate the safety and efficacy of CT-95 (study drug), a humanized T cell engaging bispecific antibody targeting Mesothelin, in subjects with advanced solid tumors associated with Mesothelin expression.
The Phase 1a Dose Escalation portion of the trial will enroll subjects in one of approximately 8 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 study in 2 dose optimization cohorts. Subjects will receive CT-95 as a single agent administered once weekly (QW) intravenously (IV) over a 4-week cycle. The Phase 1b Dose Expansion portion will evaluate CT-95 in indication-specific expansion cohorts
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-12-18 | N/A | 2025-07-29 |
2024-12-24 | N/A | 2025-07-31 |
2025-01-01 | N/A | 2025-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: CT-95 Each dose cohort will have weekly dosing. Anticipate approximately 8 dose cohorts. | DRUG: CT-95
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Determine the MTD or RD of CT-95 [Safety and Tolerability] | 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. | From date of first dose of CT-95 until 28 days following the first dose. |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The frequency and severity of adverse events, serious adverse events, and adverse events of special interest will be analyzed. | From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Evaluate Response Rates [Anti-tumor Activity] | Overall response rates will be calculated using RECIST 1.1 (and mRECIST for patients with mesothelioma) for CT-95. | 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] | PFS will be summarized using RECIST 1.1 (and mRECIST for patients with mesothelioma) for CT-95. | 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] | Overall survival will be summarized for CT-95. | From the time of the first dose of CT-95 until approximately two years post-first dose. |
| Evaluate the Maximum Serum Concentration (Cmax) [Pharmacokinetics] | Serum concentrations of CT-95 analyzed as a function of time relative to dosing will be calculated. | 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] | The AUC of CT-95 analyzed as a function of time relative to dosing will be calculated. | From date of first dose of CT-95 for 5 months or treatment discontinuation, whichever comes first. |
| Evaluate Anti-Drug Antibodies [Immunogenicity] | Incidence and titer of ADAs will be evaluated. | From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Curtis Reinard Phone Number: 267-225-7416 Email: clinical@contexttherapeutics.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
