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CT-202

Phase 1

Triple Negative Breast Cancer (TNBC) | Small molecule | Oncology |Context Therapeutics Inc.|Last Updated: Sep 1, 2026

Success Probability

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Market & Valuation

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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)
RECRUITING162 Analytics
PHASE1RECRUITING
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)Unlock trial analytics

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 Sites4

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)

LOWSep 1, 2026NCT07545122lastUpdatePostDate: changed
LOWSep 1, 2026NCT07545122lastUpdatePostDate: changed
LOWAug 31, 2026NCT07545122lastUpdatePostDate: changed
LOWAug 31, 2026NCT07545122lastUpdatePostDate: changed
LOWAug 19, 2026NCT07545122Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 19, 2026NCT07545122Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 19, 2026NCT07545122Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 9, 2026NCT07545122lastUpdatePostDate: changed
LOWJul 9, 2026NCT07545122lastUpdatePostDate: changed

Frequently asked questions about CT-202

What is CT-202 used for?

CT-202 is an investigational small molecule being developed for the treatment of Triple Negative Breast Cancer (TNBC). It is currently in Phase 1 clinical development, and the ongoing trial also includes participants with colorectal and urothelial cancers.

What does CT-202 target?

CT-202 is a Nectin-4 directed bispecific antibody, meaning it targets the Nectin-4 protein. This mechanism is being studied in the context of recurring Triple Negative Breast Cancer, colorectal cancer, and urothelial cancers.

Who makes CT-202?

CT-202 is being developed by Context Therapeutics Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol CNTX. The company is conducting a Phase 1 first-time-in-human study of this investigational drug.

What phase is CT-202 in?

CT-202 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1a/1b study is currently recruiting participants.

What clinical trials is CT-202 in?

CT-202 is being studied in a Phase 1a/1b first-time-in-human trial with the identifier NCT07545122. This recruiting study is enrolling approximately 162 participants in Australia and is investigating the drug in Triple Negative Breast Cancer, colorectal cancer, and urothelial cancers.

Is CT-202 the same as a Nectin-4 directed bispecific antibody?

Yes, CT-202 is described as a Nectin-4 directed bispecific antibody. This means it is designed to bind to Nectin-4, a protein involved in certain cancers, and is being evaluated for its safety and efficacy in a Phase 1 clinical trial.