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CT-95

Phase 1

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

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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
LOWJun 4, 2026NCT06756035lastUpdatePostDate: changed
LOWJun 4, 2026NCT06756035lastUpdatePostDate: changed
LOWJun 4, 2026NCT06756035lastUpdatePostDate: changed
LOWJun 4, 2026NCT06756035lastUpdatePostDate: changed
LOWMay 26, 2026NCT06756035primaryCompletionDate: changed
LOWMay 24, 2026NCT06756035studyFirstPostDate: changed