Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05577182 | Study of INCA32459 a LAG-3 and PD-1 Bispecific Antibody in Participants With Select Advanced Malignancies | PHASE1 | COMPLETED | 46 | — | — | Jan 5, 2023 | Oct 13, 2025 | Nov 3, 2025 | 13 | United States, Belgium +2 |
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...