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CT-95

Phase 1

Mesothelin-Expressing Tumors | Small molecule | Oncology |Context Therapeutics Inc.|Last Updated: Jun 12, 2026

Target and mechanism

Molecular targetMSLN
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

CT-95 · 1 trial · 11 indications

Phase 1 1
NCT06756035CT-95 in Advanced Cancers Associated With Mesothelin ExpressionMesothelin-Expressing Tumors
RECRUITING70 Analytics
PHASE1RECRUITING
CT-95 in Advanced Cancers Associated With Mesothelin Expression
Mesothelin-Expressing Tumors
NCT0675603570
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Study Endpoints

Primary Endpoints

Determine the MTD or RD of CT-95 [Safety and Tolerability]
From date of first dose of CT-95 until 28 days following the first dose.

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.

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
From date of first dose of CT-95 for approximately 6 months or until treatment discontinuation, whichever comes first.

The frequency and severity of adverse events, serious adverse events, and adverse events of special interest will be analyzed.

Secondary Endpoints

Evaluate Response Rates [Anti-tumor Activity]
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]
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]
From the time of the first dose of CT-95 until approximately two years post-first dose.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CT-95EXPERIMENTALPhase 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.

Interventions

NameTypeDescription
CT-95DRUGMSLN 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

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 con...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMJun 12, 2026NCT06756035lastUpdatePostDate: changed
MEDIUMJun 12, 2026NCT06756035lastUpdatePostDate: changed

Frequently asked questions about CT-95

What is CT-95 used for?

CT-95 is an investigational small molecule being developed for the treatment of mesothelin-expressing tumors, including advanced epithelial ovarian cancer, malignant pleural and peritoneal mesothelioma, advanced or metastatic pancreatic adenocarcinoma, metastatic lung adenocarcinoma, advanced or non-resectable cholangiocarcinoma, and other mesothelin-positive advanced solid tumors.

What does CT-95 target?

CT-95 targets mesothelin (MSLN), a protein that is expressed on the surface of certain tumor cells. By targeting MSLN, CT-95 is designed to address cancers that express this protein, including ovarian cancer, mesothelioma, pancreatic cancer, lung adenocarcinoma, cholangiocarcinoma, and colorectal cancer.

Who is developing CT-95?

CT-95 is being developed by Context Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CNTX. The company is conducting clinical research to evaluate the safety and efficacy of CT-95 in patients with mesothelin-expressing advanced cancers.

What phase is CT-95 in?

CT-95 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting patients to evaluate the drug in advanced cancers associated with mesothelin expression.

What clinical trials is CT-95 in?

CT-95 is being studied in a single Phase 1 clinical trial with the identifier NCT06756035, titled "CT-95 in Advanced Cancers Associated With Mesothelin Expression." The trial is recruiting in the United States and plans to enroll approximately 70 adult patients with mesothelin-expressing tumors.

Is CT-95 the same as mesothelin?

No, CT-95 is not the same as mesothelin. Mesothelin (MSLN) is the protein target that CT-95 is designed to act upon. CT-95 is a small molecule drug candidate that targets mesothelin-expressing tumor cells, while mesothelin itself is a protein found on the surface of certain cancer cells.