Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCAGN01949 · 2 trials · 2 indications
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death due to AE.
ORR was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as determined by investigator assessment of radiographic disease assessments, recorded before and including the first event of progressive disease (PD). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
| Arm | Type | Description |
|---|---|---|
| Phase 1, Dose Escalation: INCAGN01949 + Nivolumab | EXPERIMENTAL | INCAGN01949 (70, 200, 350, or 700 milligrams \[mg\]) combined with nivolumab 240 mg in participants with advanced or metastatic select solid tumors |
| Phase 1, Dose Escalation: INCAGN01949 + Ipilimumab | EXPERIMENTAL | INCAGN01949 (70, 200, 350, or 700 mg) combined with ipilimumab 1 mg/kilogram (kg) in participants with advanced or metastatic select solid tumors |
| Phase 1, Dose Escalation: INCAGN01949 + Nivolumab + Ipilimumab | EXPERIMENTAL | INCAGN01949 combined with nivolumab 3 mg/kg and ipilimumab 1 mg/kg in participants with advanced or metastatic select solid tumors |
| Phase 1, Safety Expansion: INCAGN01949 + Nivolumab | EXPERIMENTAL | Run-in with INCAGN01949 (70, 200, or 350 mg) x 2 doses, followed by INCAGN01949 (70, 200, or 350 mg) combined with nivolumab 240 mg in participants with advanced or metastatic select solid tumors |
| Phase 1, Safety Expansion: INCAGN01949 + Nivolumab + Ipilimumab | EXPERIMENTAL | Run-in with INCAGN01949 x 2 doses, followed by INCAGN01949 combined with nivolumab 3 mg/kg and ipilimumab 1 mg/kg in participants with advanced or metastatic select solid tumors |
| Phase 2, Part A: INCAGN01949 + nivolumab | EXPERIMENTAL | INCAGN01949 combined with nivolumab in programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) refractory participants with gastric cancer, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC) |
| Phase 2, Part B: INCAGN01949; INCAGN01949 + nivolumab; INCAGN01949 + nivolumab + ipilimumab | EXPERIMENTAL | INCAGN01949 alone, combined with nivolumab, and combined with nivolumab and ipilimumab in PD-1/L1 refractory participants with advanced or metastatic gastric cancer, SCCHN, NSCLC, or RCC |
| INCAGN01949 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| INCAGN01949 | DRUG | In Phase 1, participants will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, participants will receive INCAGN01949 administered IV at the recommended dose from Phase 1. |
| Nivolumab | DRUG | Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group. |
| Ipilimumab | DRUG | Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group. |
Inclusion Criteria: * Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * Phase 1: Subjects with advanced or metastatic solid tumors. * Phase 1: Subjects who have disease progression after treatment with available therapies. * P...
INCAGN01949 is an investigational small molecule being developed for advanced malignancies, including advanced or metastatic solid tumors and advanced or metastatic malignancies. It is currently in Phase 1 clinical development and is not approved by the FDA.
INCAGN01949 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The drug is an investigational small molecule in Phase 1 clinical development for advanced malignancies.
INCAGN01949 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both studying the drug in patients with advanced or metastatic solid tumors or advanced malignancies. The drug is investigational and has not been approved by regulatory authorities.
INCAGN01949 has been studied in two completed Phase 1 trials. NCT02923349 evaluated the drug as a single agent in 87 subjects with advanced or metastatic solid tumors. NCT03241173 explored the drug in combination with immune therapies in 52 subjects with advanced or metastatic malignancies.
INCAGN01949 is the primary name for this investigational small molecule developed by Incyte Corporation. No alternative names have been reported for this drug in the available clinical trial information.