Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCA32459-101 · 1 trial · 1 indication
Toxicities occurring during Part 1 will define tolerability. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.
TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Dose interruptions will occur according to protocol guidelines.
TEAE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | INCA32459 will be administered at a protocol defined starting regimen intravenously. Subsequent dose regimens will be determined during study conduct. |
| Part 2: Dose Expansion Cohort Disease Group 1 | EXPERIMENTAL | INCA32459 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for unresectable or metastatic melanoma. |
| Part 2: Dose Expansion Cohort Disease Group 2 | EXPERIMENTAL | INCA32459 will be administered at the recommended dose or doses for expansion (RDE\[s\]) for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) that is PD-L1 positive. |
| Name | Type | Description |
|---|---|---|
| INCA32459-101 | DRUG | solution for infusion |
Inclusion Criteria: * Histologically or cytologically confirmed advanced malignancies as follows: 1. Part 1 only: Participants with the select advanced malignancies as specified in the protocol. 2. Part 2 only: * Cohort 1 only: Participants with Stage III (unresectable) or Stage IV (meta...
INCA32459-101 is an investigational small molecule being studied for the treatment of advanced malignancies. It is currently in Phase 1 clinical development, with a completed trial that enrolled 46 participants across the United States, Belgium, Italy, and Spain.
INCA32459-101 is a bispecific antibody that targets both LAG-3 and PD-1, two immune checkpoint proteins involved in regulating T-cell responses. By engaging these targets, it is designed to modulate the immune system's ability to fight cancer cells.
INCA32459-101 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting clinical research on this investigational therapy for advanced malignancies.
INCA32459-101 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under clinical investigation for advanced malignancies.
INCA32459-101 has one completed clinical trial, identified as NCT05577182. This Phase 1 study, titled 'Study of INCA32459 a LAG-3 and PD-1 Bispecific Antibody in Participants With Select Advanced Malignancies,' enrolled 46 adults aged 18 years and older in the United States, Belgium, Italy, and Spain.
INCA32459-101 is the drug name used in the clinical trial record, while the trial title refers to the drug as INCA32459. These names refer to the same investigational bispecific antibody targeting LAG-3 and PD-1, developed by Incyte Corporation.