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CT-202

Phase 1

Triple Negative Breast Cancer (TNBC) | Small molecule | Oncology |Context Therapeutics Inc.|Last Updated: Jul 9, 2026

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Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment162
FDA Designations
No designations recorded
Clinical trial landscape

CT-202 · 1 trial · 3 indications

Phase 1 1
NCT07545122A Phase 1a/1b, First-Time-in-Human Study of CT-202, a Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, Urothelial CancersTriple Negative Breast Cancer (TNBC)
NOT YET_RECRUITING162 Analytics
PHASE1NOT YET_RECRUITING
A Phase 1a/1b, First-Time-in-Human Study of CT-202, a Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, Urothelial Cancers
Triple Negative Breast Cancer (TNBC)
NCT07545122162
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Study Endpoints
Primary Endpoints
Phase 1a: Incidence of Dose Limiting Toxicities (DLTs)
From date of first dose of CT-202 until 28 days following the first dose

Phase 1a will evaluate increasing doses of CT-202 based on the assessment of DLTs

Phase 1b: Overall response rate (ORR)
From date of first dose of CT-202until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

ORR will be based on the overall response rate as assessed by Investigators according to RECIST v1.1

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1aEXPERIMENTALDose Escalation-Bayesian Optimal Interval (BOIN) Design with approximately 54 patients in dose escalation.
Phase 1bEXPERIMENTALPhase 1b: Dose Expansion - participants will be evaluated in 4-6 cohorts at different doses and schedules of CT-202
Interventions
NameTypeDescription
CT-202DRUGNectin-4 bispecific
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Participants with nectin-4-positive triple negative breast cancer, colorectal cancer, or urothelial cancer that have received standard therapies * Participants with measurable disease per RECIST 1.1 * ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks * Participants have adequa...

Countries:Australia
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Recent Changes (Last 90 Days)
LOWJul 9, 2026NCT07545122lastUpdatePostDate: changed
LOWJul 9, 2026NCT07545122lastUpdatePostDate: changed
LOWMay 26, 2026NCT07545122primaryCompletionDate: changed
LOWMay 24, 2026NCT07545122studyFirstPostDate: changed
LOWMay 21, 2026NCT07545122NEW_TRIAL: changed
LOWMay 21, 2026NCT07545122NEW_TRIAL: changed