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CT-95

Phase 1

Mesothelin-Expressing Tumors | Small molecule | Oncology |Context Therapeutics Inc.|Last Updated: Jun 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06756035CT-95 in Advanced Cancers Associated With Mesothelin ExpressionPHASE1 RECRUITING 70 — — Mar 31, 2025Dec 1, 2028Jun 4, 20269 United States
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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-95EXPERIMENTALEach dose cohort will have weekly dosing. Anticipate approximately 8 dose cohorts.
Interventions
NameTypeDescription
CT-95DRUGWeekly IV dosing
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Eligibility Criteria
Age Range18 Years — 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)
LOWJun 4, 2026NCT06756035lastUpdatePostDate: changed
LOWJun 4, 2026NCT06756035lastUpdatePostDate: changed
LOWJun 4, 2026NCT06756035lastUpdatePostDate: changed
LOWJun 4, 2026NCT06756035lastUpdatePostDate: changed
LOWMay 26, 2026NCT06756035primaryCompletionDate: changed
LOWMay 24, 2026NCT06756035studyFirstPostDate: changed