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 developed by Incyte Corporation for the treatment of select advanced malignancies. It has been studied in a Phase 1 clinical trial in adults with advanced solid tumors. It is not an approved therapy and remains in clinical development.
INCA32459-101 is being evaluated for the treatment of select advanced malignancies in adults. The Phase 1 study enrolled participants with advanced solid tumors across sites in the United States, Belgium, Italy, and Spain. No approved indication has been established for this agent.
INCA32459-101 is being developed by Incyte Corporation, which trades on the Nasdaq under the ticker INCY. Incyte is the sponsor of the Phase 1 clinical program evaluating the agent in participants with select advanced malignancies.
INCA32459-101 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The agent is investigational and has not been approved by the FDA for any indication.
INCA32459-101 has been studied in the Phase 1 trial NCT05577182, titled Study of INCA32459 a LAG-3 and PD-1 Bispecific Antibody in Participants With Select Advanced Malignancies. The trial enrolled 46 participants aged 18 years and older across the United States, Belgium, Italy, and Spain, and it is now completed.