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

ConditionsTriple Negative Breast Cancer (TNBC)Colorectal Cancer Urothelial Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorContext Therapeutics Inc.

About this trial

This is a Phase 1a/1b, first time in human (FTIH), open-label, dose escalation and expansion study to evaluate the safety, tolerability, and preliminary efficacy of CT-202 (study drug), a humanized T cell engaging bispecific antibody targeting nectin-4, in participants with nectin-4 expressing recurrent, unresectable or metastatic refractory/resistant TNBC, CRC, or UC. Results of the study including PK, PD, efficacy, and safety will be used in the RP2D determination.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 adequate organ function.

Disqualifiers

History of severe skin toxicity

Uncontrolled significant active infection or any medical or other condition that in the opinion of the Investigator would preclude the participant's participation in the study.

Concurrent participation in another investigational clinical trial.

Trial design

Design model

Single group

Treatments tested in this trial

CT-202
Drug
Nectin-4 bispecific

Treatment groups

162 Participants

are divided into 2 treatment groups

Group A: Phase 1aExperimental treatment 1 intervention

Group B: Phase 1bExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Phase 1a: Incidence of Dose Limiting Toxicities (DLTs)

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

Time frame

From date of first dose of CT-202 until 28 days following the first dose

Phase 1b: Overall response rate (ORR)

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

Time frame

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

Sponsors and contacts

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Context Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov

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