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INCAGN02385 · 2 trials · 18 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. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.
The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment 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 treatment indicated. Grade 5: fatal. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE reported either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.
TEAE defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
| Arm | Type | Description |
|---|---|---|
| Phase 1 Part 1 | EXPERIMENTAL | Part 1 will confirm the safety of INCAGN02385 and INCAGN02390 when used in combination. INCAGN02385 will be administered first intravenously followed by INCAGN02390. |
| Phase 1 Part 2 | EXPERIMENTAL | Part 2 will confirm the safety of the triple combination of INCAGN02385 + INCAGN02390 + INCMGA00012, following confirmation of the safety of the doublet in Part 1. INCAGN02385 will be administered first intravenously followed by INCAGN02390 and INCMGA00012. |
| Phase 2 Cohort A | EXPERIMENTAL | Phase 2 will determine preliminary efficacy and proof of concept for the combination of INCAGN02385 + INCAGN02390 + INCMGA00012. INCAGN02385 will be administered first intravenously followed by INCAGN02390 and INCMGA00012 |
| Phase 2 Cohort B | EXPERIMENTAL | Phase 2 will determine preliminary efficacy and proof of concept for the combination of INCAGN02385 + INCAGN02390 + INCMGA00012. INCAGN02385 will be administered first intravenously followed by INCAGN02390 and INCMGA00012 |
| Phase 1 Part 3 | EXPERIMENTAL | Part 1 will confirm the safety of INCAGN02385 + INCAGN02390 + INCMGA00012 when used in combination. |
| Phase 1 Part 4 | EXPERIMENTAL | Part 1 will confirm the safety of INCAGN02385 + INCAGN02390 + INCMGA00012 in combination. |
| INCAGN02385 | EXPERIMENTAL | Part 1: INCAGN02385 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation to determine the maximum tolerated dose or pharmacologically active dose. Part 2: INCAGN02385 administered Q2W or Q4W at the recommended dose(s) from Part 1. |
| Name | Type | Description |
|---|---|---|
| INCAGN02385 | DRUG | INCAGN02385 administered intravenously |
| INCAGN02390 | DRUG | INCAGN02390 administered intravenously |
| INCMGA00012. | DRUG | INCMGA00012 administered intravenously |
Inclusion Criteria: * Phase 1 Parts 1-4): Participants with locally advanced or metastatic solid tumors (locally advanced disease must not be amenable to resection with curative intent) that have failed available therapies, including anti-PD-(L)1 therapy if applicable, that are known to confer clin...
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INCAGN02385 is an investigational monoclonal antibody being studied for the treatment of advanced malignancies, including melanoma and cervical cancer. It has been evaluated in Phase 1 clinical trials for these and other solid tumors. The drug is not yet approved and remains in clinical development.
INCAGN02385 is a monoclonal antibody that targets LAG-3, an immune checkpoint protein. By binding to LAG-3, it is designed to modulate the immune system's response against cancer cells. This mechanism is being investigated in combination with other immunotherapies for advanced malignancies.
INCAGN02385 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. Incyte is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy in patients with advanced cancers.
INCAGN02385 is in Phase 1 clinical development. It has been studied in early-stage trials to assess safety, tolerability, and preliminary efficacy. The drug is investigational and has not received FDA approval for any indication.
INCAGN02385 has been studied in two completed Phase 1 trials. NCT03538028 evaluated the drug as a single agent in multiple advanced malignancies, including cervical cancer and melanoma. NCT04370704 tested it in combination with INCMGA00012 and INCAGN02390 in participants with advanced melanoma.
INCAGN02385 is an anti-LAG-3 monoclonal antibody. It is designed to bind to the LAG-3 protein, which is expressed on immune cells. This investigational drug is being studied for its potential role in cancer immunotherapy, particularly in combination with other checkpoint inhibitors.