Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCAGN02385 · 2 trials · 18 indications
TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug
Defined as the percentage of participants having a Complete Response or Partial Response, will be determined by investigator assessment of radiographic disease assessments per RECIST v1.1.
Defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death from any cause, if occurring sooner than progression.
Defined as percentage of participants having CR, PR, or SD as best on-study response.
Defined as the time from date of first dose of study treatment until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease per RECIST v1.1
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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