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CT-202

Phase 1

Triple Negative Breast Cancer (TNBC) | Small molecule | Oncology |Context Therapeutics Inc.|Trials Updated: Oct 8, 2026

CT-202 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2026

CT-202 target and mechanism

Molecular targetNectin-4
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment162

FDA Designations

No designations recorded

CT-202 clinical trials

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 Sites6

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)

LOWOct 8, 2026NCT07545122lastUpdatePostDate: changed
LOWOct 8, 2026NCT07545122lastUpdatePostDate: changed
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

Frequently asked questions about CT-202

What is CT-202?

CT-202 is an investigational small molecule developed by Context Therapeutics Inc. (ticker CNTX) for the treatment of triple negative breast cancer (TNBC). It is being studied in a first-time-in-human Phase 1a/1b clinical trial that also enrolls participants with colorectal and urothelial cancers. CT-202 has not been approved by the FDA and remains in clinical development.

What is CT-202 used for in triple negative breast cancer?

CT-202 is being developed for triple negative breast cancer (TNBC), an aggressive form of breast cancer. The Phase 1a/1b trial of CT-202 enrolls participants with recurring TNBC, and also includes cohorts with colorectal cancer and urothelial cancer. CT-202 is investigational and has not been approved for any indication.

What does CT-202 target?

CT-202 targets Nectin-4, a protein expressed on tumor cells. CT-202 is described as a Nectin-4 directed bispecific antibody, meaning it is designed to bind Nectin-4 and engage a second target to drive an anti-tumor response. The Phase 1a/1b study is biomarker selected, enrolling participants whose tumors express the relevant biomarker.

Who is developing CT-202?

CT-202 is being developed by Context Therapeutics Inc., which trades under the ticker CNTX. The company is running the first-time-in-human Phase 1a/1b study of CT-202 in participants with recurring triple negative breast, colorectal, and urothelial cancers. The trial is currently recruiting in Australia.

What phase is CT-202 in?

CT-202 is in Phase 1 development. The ongoing study is a Phase 1a/1b, first-time-in-human trial that is currently recruiting participants. CT-202 is investigational and has not received FDA approval. The trial has a planned enrollment of 162 participants and includes a controlled, randomized design.

What clinical trials is CT-202 in?

CT-202 is being studied in one active clinical trial, NCT07545122, titled 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, and urothelial cancers. The trial is recruiting, has a planned enrollment of 162 participants, and is conducted in Australia in adults 18 years and older.