Mesothelin-Expressing TumorsPhase 1NCT06756035
CT-95 in Advanced Cancers Associated With Mesothelin Expression
A Phase 1 study testing CT-95 in people with Mesothelin-Expressing Tumors and Epithelial Ovarian Cancer, run by Context Therapeutics Inc. at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelin-Expressing Tumors, Epithelial Ovarian Cancer, Malignant Pleural Mesothelioma, Advanced
- What is being tested?
- CT-95
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 9 sitesUnited States
- Study dates
- 31 Mar 2025to Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Context Investigational Site
Chicago, Illinois, 60637
Cancer Clinical Trials, 773-702-6233, Cancerclinicaltrials@bsd.uchicago.edu
- Recruiting
Context Investigational Site
Denver, Colorado, 80218
Front Desk, 720-754-2610, CANN.DDUDenverGeneral@SarahCannon.com
- Recruiting
Context Investigational Site
Grand Rapids, Michigan, 49546
Ashley Spagnuolo, 616-954-5552, ashley.spagnuolo@startresearch.com
- Recruiting
Context Investigational Site
Hackensack, New Jersey, 07601
Oncology Clinical Research Referral Office, 551-996-1777, OncologyResearchReferral@hmhn.org
- Recruiting
Context Investigational Site
Nashville, Tennessee, 37203
Sarah Cannon Research Institute, 844-482-4812
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Andrea Standish, 215-662-2419, Andrea.Standish@Pennmedicine.upenn.edu
- Recruiting
Context Investigational Site
Philadelphia, Pennsylvania, 19107
Ask Phase1, 215-586-0199, AskPhase1@jefferson.edu
- Recruiting
Context Investigational Site
San Antonio, Texas, 78229
Clinical Trial Navigator, 210-580-9521, jgeorg@nextoncology.com
- Recruiting
Context Investigational Site
San Antonio, Texas, 78229
Isabel Jimenez, 210-593-5265, isabel.jimenez@startresearch.com
Christina Santana, csantana@startresearch.com
About this study
Official title: Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression
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.
Read the 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.
- Conditions
- Mesothelin-Expressing Tumors, Epithelial Ovarian Cancer, Malignant Pleural Mesothelioma, Advanced, Malignant Peritoneal Mesothelioma, Advanced, Pancreatic Adenocarcinoma Advanced or Metastatic, Lung Adenocarcinoma Metastatic
- Being tested
- CT-95
- Keywords
- Phase 1 Dose Escalation Study, CT-95, Advanced, recurrent cancers, Unresectable, metastatic cancers, Cancers associated with mesothelin expression
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Mesothelioma, Malignant, Neoplasm Metastasis, Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-95Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| CT-95 | Experimental | 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. Receives: Drug: CT-95 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From date of first dose of CT-95 for 5 months or until treatment discontinuation, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start31 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesothelin-Expressing TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Context Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Chagin, MD, Study director, Context Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756035
- Sponsor's protocol ID
- CNTX-CT95-101
- Status last verified
- Jun 2026
- First submitted
- 18 Dec 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No