Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATX-898 · 1 trial · 1 indication
Toxicities occurring within the first treatment cycle (28 days). DLTs will be assessed in severity by the investigators per CTCAE v 6.0
Maximum dose deemed safe and well tolerated during dose escalation
Monotherapy dose recommended to test during dose expansion
Any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Percentage of participants with confirmed CR or PR per RECIST 1.1
Toxicities occurring within the first treatment cycle of combination therapy (28 days). DLTs will be assessed in severity by the investigators per CTCAE v 6.0
Maximum dose deemed safe and well tolerated during dose escalation of with combination treatment
Recommended dose for expansion (RDE) Monotherapy dose recommended to test during dose expansion of combination treatment 18 months
Any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug. 18 months
Percentage of participants with confirmed CR or PR per RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| Part 1a: Monotherapy Dose Escalation | EXPERIMENTAL | ATX-898 will be given at a protocol defined starting dose for the treatment of participants with selected advanced or metastatic solid tumors. Subsequent dose regimen will be determined during study execution |
| Part 1b1: Monotherapy Dose Expansion Cohort Disease Group 1 | EXPERIMENTAL | ATX-898 will be given at the recommended dose for expansion (RDE) for the treatment of participants with selected advanced or metastatic ovarian cancer |
| Part 1b2: Monotherapy Dose Expansion Cohort Disease Group 2 | EXPERIMENTAL | ATX-898 will be given at the recommended dose for expansion (RDE) for the treatment of participants with selected advanced or metastatic gynecologic cancers other than ovarian cancers |
| Part 1b2: Monotherapy Dose Expansion Cohort Disease Group 3 | EXPERIMENTAL | ATX-898 will be given at the recommended dose for expansion (RDE) for the treatment of participants with selected advanced or metastatic solid tumors other than gynecologic cancers |
| Part 2a 1: Combination Dose Escalation | EXPERIMENTAL | ATX-898 will be given at a recommended starting dose in combination with fulvestrant and abemaciclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer. Subsequent dose regimen of ATX-898 will be determined during study execution |
| Part 2b 1: Combination Dose Expansion | EXPERIMENTAL | ATX-898 will be given at a recommended dose for expansion (RDE) in combination with fulvestrant and abemaciclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer |
| Part 2b 2: Combination Dose Expansion | EXPERIMENTAL | ATX-898 will be given at a recommended dose for expansion (RDE) in combination with fulvestrant and ribociclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer |
| Part 2a 2: Combination Dose Escalation | EXPERIMENTAL | ATX-898 will be given at a recommended starting dose in combination with fulvestrant and ribociclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer Subsequent dose regimen of ATX-898 will be determined during study execution |
| Name | Type | Description |
|---|---|---|
| ATX-898 | DRUG | Doses defined per protocol |
| ATX-898, fulvestrant, ribociclib | DRUG | ATX-898 at RDE, Fulvestrant and abemaciclib: doses defined per protocol |
Inclusion Criteria: * Has histologically or cytologically confirmed advanced solid tumor malignancy that is metastatic or locally advanced and unresectable * Is ≥18 years of age at the time of signing the informed consent form * ECOG performance status score of 0 or 1 * Adequate organ function * Mu...
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