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RLY-2608 · 3 trials · 16 indications
| Arm | Type | Description |
|---|---|---|
| RLY-2608 + fulvestrant | EXPERIMENTAL | RLY-2608 + fulvestrant combination for participants with HR+/HER2- advanced breast cancer |
| capivasertib + fulvestrant | ACTIVE_COMPARATOR | capivasertib + fulvestrant combination for participants with HR+/HER2- advanced breast cancer |
| Part 1, Group 1 | EXPERIMENTAL | RLY-2608 for patients ≥12 years old with PROS or malformations with PIK3CA mutation. Multiple doses of RLY-2608 for oral administration. |
| Part 1, Group 2 | EXPERIMENTAL | RLY-2608 for participants 6 to \<12 years old with PROS or malformations with PIK3CA mutation. RLY-2608 will be studied in pediatric participants in a dose escalation design. |
| Part 1, Group 3 | EXPERIMENTAL | Part 1, Group 3: RLY-2608 for participants 2 to \<6 years old with PROS or malformations with PIK3CA mutation. RLY-2608 will be studied in pediatric participants in a dose escalation design. |
| Part 2, Group 1 | EXPERIMENTAL | Dose expansion single-arm cohorts for various subpopulations of participants ≥12 years old with PROS or malformations with PIK3CA mutation. Oral dose of RLY-2608 as determined during Part 1. |
| Part 2, Group 2 | EXPERIMENTAL | Dose expansion cohorts for participants 6 to \<12 years old with PROS or malformations with PIK3CA mutation. Oral dose of RLY-2608 as determined during Part 1. |
| Part 2, Group 3 | EXPERIMENTAL | Dose expansion cohorts for participants 2 to \<6 years old with PROS or malformations with PIK3CA mutation. Oral dose of RLY-2608 as determined during Part 1. |
| Part 3, Arm 1 | EXPERIMENTAL | Adult (\>18 yo) and pediatric (6 to \<18 yo) participants with PROS and malformations with PIK3CA mutation will be randomized to receive RLY-2608 at oral dose determined during Part 1/2. |
| Part 3, Arm 2 | PLACEBO_COMPARATOR | Adult (\>18 yo) and pediatric (6 to \<18 yo) participants with PROS and malformations with PIK3CA mutation will be randomized to receive placebo. |
| RLY-2608 for patients with unresectable or metastatic solid tumors | EXPERIMENTAL | Multiple doses of RLY-2608 for oral administration. |
| RLY-2608 + fulvestrant combination for HR+ HER2- locally advanced or metastatic breast cancer | EXPERIMENTAL | Oral dose of RLY-2608 in addition to fulvestrant as determined during Part 1 Dose Escalation. |
| RLY-2608+fulvestrant+palbo125mg for HR+HER2- locally advanced metastatic breast cancer | EXPERIMENTAL | Oral dose of RLY-2608 in addition to fulvestrant and palbociclib 125mg as determined during Part 1 Dose Escalation. |
| RLY-2608+fulvestrant+ribo400mg for HR+HER2- locally advanced metastatic breast cancer | EXPERIMENTAL | Oral dose of RLY-2608 in addition to fulvestrant and ribociclib 400mg as determined during Part 1 Dose Escalation. |
| RLY-2608+fulvestrant+ribo600mg for HR+HER2- locally advanced metastatic breast cancer | EXPERIMENTAL | Oral dose of RLY-2608 in addition to fulvestrant and ribociclib 600mg as determined during Part 1 Dose Escalation. |
| RLY-2608+fulvestrant+PF-07220060 100 mg for HR+ HER2- locally advanced or metastatic breast cancer | EXPERIMENTAL | Oral dose of RLY-2608 in addition to fulvestrant and PF-07220060 100 mg as determined during Part 1 Dose Escalation |
| RLY-2608+fulvestrant+PF-07220060 300 mg for HR+ HER2- locally advanced or metastatic breast cancer | EXPERIMENTAL | Oral dose of RLY-2608 in addition to fulvestrant and PF-07220060 300 mg as determined during Part 1 Dose Escalation |
| Name | Type | Description |
|---|---|---|
| RLY-2608 | DRUG | 400 mg orally BID administered daily on a 28-day treatment cycle |
| Capivasertib | DRUG | 400mg orally BID administered on an intermittent weekly dosing schedule. Patients will dose on Days 1 through 4 each week of a 28-day treatment cycle |
| Fulvestrant | DRUG | 500 mg intramuscularly administered on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (28-day treatment cycle) |
| Placebo | DRUG | RLY-2608 matched-placebo |
| Palbociclib 125mg | DRUG | 125mg palbociclib is taken orally once daily for 28-day cycles that include 21 days of treatment followed by 7 days off treatment. |
| Ribociclib 400mg | DRUG | 400mg ribociclib is taken orally once daily for 28-day cycles that include 21 days of treatment followed by 7 days off treatment. |
| Ribociclib 600mg | DRUG | 600mg ribociclib is taken orally once daily for 28-day cycles that include 21 days of treatment followed by 7 days off treatment. |
| PF-07220060 100mg | DRUG | PF-07220060 100 mg is taken orally twice daily at the same time with RLY-2608 during each 28-day cycle. |
| PF-07220060 300 mg | DRUG | PF-07220060 300 mg is taken orally twice daily at the same time with RLY-2608 during each 28-day cycle. |
Inclusion Criteria: * Patient has ECOG performance status of 0-1 * One or more known primary oncogenic PIK3CA mutation(s) * Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with a gonadotropin-releasing ...