First-in-Human Study of RLY-2608
Phase 1
930
about 5.4 years
18+
24 sites in AZ, CA, CO +15
What this study is about
Researchers are testing the safety and how well RLY-2608 works in people with advanced solid tumors who have a PIK3CA mutation. The trial will also test if RLY-2608 combined with other medications is safe and effective for breast cancer patients.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Fulvestrant
- 2.Take PF-07220060 100mg
- 3.Take PF-07220060 300 mg
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
fulvestrant, palbociclib, ribociclib
injection, oral (Oral Capsule), oral (Oral Tablet)
Primary: Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RLY-2608 as a single agent, Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RLY-2608 in combination with fulvestrant, Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RLY-2608 in combination with fulvestrant and a CDK 4/6 inhibitor (palbociclib, ribociclib), and in combination with CDK4 inhibitor (PF-07220060) and fulvestrant, Number of patients with adverse events and serious adverse events of RLY-2608 as a single agent, Number of patients with adverse events and serious adverse events of RLY-2608 in combination with fulvestrant, Number of patients with adverse events and serious adverse events of RLY-2608 in combination with fulvestrant and a CDK 4/6 inhibitor (palbociclib, ribociclib), and in combination with CDK4 inhibitor (PF-07220060) and fulvestrant
Secondary: Changes in circulating blood of HbA1c in RLY-2608 as a single agent, Changes in circulating blood of HbA1c in RLY-2608 in combination with fulvestrant, Changes in circulating blood of HbA1c in RLY-2608 in combination with fulvestrant and a CDK4/6 inhibitor (palbociclib, ribociclib), and in combination with CDK4 inhibitor (PF-07220060) and fulvestrant, Disease Control Rate (DCR) as assessed by RECIST v1.1, Duration of Response (DOR) as assessed by RECIST v1.1, Objective response rate (ORR) as assessed by RECIST v1.1, PK parameters including area under the plasma concentration vs time curve during a dose interval (AUC0-tau) of RLY-2608 (and its metabolites, as appropriate) administered with fulvestrant + palbociclib, or ribociclib, or PF-07220060, PK parameters including maximum plasma drug concentration (Cmax) of RLY-2608 (and its metabolites, as appropriate) when RLY-2608 is administered in combination with fulvestrant + palbociclib or ribociclib, and in combination (PF-07220060) +fulvestrant
Oncology