Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRT13722 · 1 trial · 7 indications
Incidence of dose limiting toxicities, defined according to protocol-specified criteria
Safety and tolerability assessed by the number of participants with treatment-emergent adverse events, serious adverse events, adverse events leading to dose modification, treatment interruption, or treatment discontinuation, and clinically significant laboratory abnormalities. Adverse events and selected laboratory abnormalities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 6.0
Proportion of patients with best overall response of either complete response or partial response, as assessed by the investigator per RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| PRT13722 Monotherapy | EXPERIMENTAL | Participants receive PRT13722 once daily as monotherapy. This arm includes dose-escalation (Part 1A) and backfill cohorts (Part 1B) evaluating PRT13722 in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer to support the selection of RDE. |
| PRT13722 + Fulvestrant | EXPERIMENTAL | Participants receive PRT13722 once daily in combination with fulvestrant. This study includes a dose-escalation (Part 2A) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3A) at the RDE. |
| PRT13722 + Abemaciclib + Fulvestrant | EXPERIMENTAL | Participants receive PRT13722 once daily in combination with abemaciclib and fulvestrant. This study includes a dose-escalation (Part 2B) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3B) at the RDE. |
| PRT13722 + Imlunestrant | EXPERIMENTAL | Participants receive PRT13722 once daily in combination with imlunestrant. This study includes a dose-escalation (Part 2C) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3C) at the RDE. |
| Name | Type | Description |
|---|---|---|
| PRT13722 | DRUG | PRT13722 is an investigational oral drug administered once daily at the assigned dose level. |
| Fulvestrant | DRUG | Fulvestrant is an approved selective estrogen receptor degrader (SERD) administered on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, then once monthly as an intramuscular injection into the buttocks (gluteal muscle). |
| Abemaciclib | DRUG | Abemaciclib is an approved oral cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor administered twice daily and used in combination with endocrine therapy for HR-positive, HER2-negative breast cancer. |
| Imlunestrant | DRUG | Imlunestrant is an approved oral SERD administered once daily. |
Inclusion Criteria: * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures. * histological or cytological diagnosis of locally advanced or metastatic HR-positive/HER2-negat...
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