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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT-202.
- Who it may be relevant to
- Registry conditions: Triple Negative Breast Cancer (TNBC), Colorectal Cancer, Urothelial Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
Phase 1a Dose Escalation: Will follow a Bayesian Optimal Interval (BOIN) design (Liu, 2015) with step up dosing (i.e. priming followed by full doses of CT-202), Q2W administration schedule, and approximately 6 dose levels. Participants will continue study treatment until confirmed disease progression, the occurrence of unacceptable toxicity, withdrawal from the study or decision to discontinue treatment by the investigator.
Phase 1b Dose Expansion: Upon completion of the dose escalation Phase 1a, CT-202 may be evaluated at 2 or more dose levels and 2 or more dosing schedules in at least 4 but up to 6 expansion cohorts. The population(s) will include participants with the same tumor indications, or subsets, evaluated in the dose escalation phase (TNBC, CRC, or UC). Up to 15 participants will be assigned to each dosing cohort.
Based on the totality of data from Phase 1b, a RP2D for future clinical studies will be determined.
Interventions
- Drug CT-202
Nectin-4 bispecific
Primary outcome measures
- Phase 1a: Incidence of Dose Limiting Toxicities (DLTs) [Time frame: From date of first dose of CT-202 until 28 days following the first dose]
- Phase 1b: Overall response rate (ORR) [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]
Eligibility criteria
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 adequate organ function.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 3 centers
- Tasman Oncology Research — Gold Coast
- Calvary Mater Hospital Newcastle — Newcastle
- Linear Clinical Research — Perth
Identifiers
NCT: NCT07545122 · CNTX-CT202-101