First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
NCT ID: NCT05759949
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2023-03-29
2025-04-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RLY-5836 Single Agent Arm
RLY-5836 single agent arm for participants with unresectable or metastatic solid tumors
RLY-5836
RLY-5836 is a mutant-selective, oral PI3Kα inhibitor.
RLY-5836 + Fulvestrant Arm
RLY-5836 + fulvestrant combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer
RLY-5836
RLY-5836 is a mutant-selective, oral PI3Kα inhibitor.
Fulvestrant
Fulvestrant (500 mg) is administered IM into the buttocks (gluteal area) slowly (1 to 2 minutes per injection) as 2×5 mL injections, 1 in each buttock, on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of each subsequent cycle.
RLY-5836 + Palbociclib + Fulvestrant Arm
RLY-5836 + palbociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer
RLY-5836
RLY-5836 is a mutant-selective, oral PI3Kα inhibitor.
Fulvestrant
Fulvestrant (500 mg) is administered IM into the buttocks (gluteal area) slowly (1 to 2 minutes per injection) as 2×5 mL injections, 1 in each buttock, on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of each subsequent cycle.
Palbociclib
Palbociclib 125 mg once daily is taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles that include 21 days of treatment followed by 7 days off treatment.
RLY-5836 + Ribociclib + Fulvestrant Arm
RLY-5836 + ribociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer
RLY-5836
RLY-5836 is a mutant-selective, oral PI3Kα inhibitor.
Fulvestrant
Fulvestrant (500 mg) is administered IM into the buttocks (gluteal area) slowly (1 to 2 minutes per injection) as 2×5 mL injections, 1 in each buttock, on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of each subsequent cycle.
Ribociclib
Ribociclib 600 mg once daily is taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles that include 21 days of treatment followed by 7 days off treatment.
RLY-5836 + Abemaciclib + Fulvestrant Arm
RLY-5836 + abemaciclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer
RLY-5836
RLY-5836 is a mutant-selective, oral PI3Kα inhibitor.
Fulvestrant
Fulvestrant (500 mg) is administered IM into the buttocks (gluteal area) slowly (1 to 2 minutes per injection) as 2×5 mL injections, 1 in each buttock, on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of each subsequent cycle.
Abemaciclib
Abemaciclib 150 mg BID will be taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles.
Interventions
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RLY-5836
RLY-5836 is a mutant-selective, oral PI3Kα inhibitor.
Fulvestrant
Fulvestrant (500 mg) is administered IM into the buttocks (gluteal area) slowly (1 to 2 minutes per injection) as 2×5 mL injections, 1 in each buttock, on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of each subsequent cycle.
Palbociclib
Palbociclib 125 mg once daily is taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles that include 21 days of treatment followed by 7 days off treatment.
Ribociclib
Ribociclib 600 mg once daily is taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles that include 21 days of treatment followed by 7 days off treatment.
Abemaciclib
Abemaciclib 150 mg BID will be taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor per local assessment
* Disease that is refractory to standard therapy, intolerant to standard therapy, or participant has declined standard therapy.
* A histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor
* Males, postmenopausal females, or pre-/perimenopausal females previously treated with gonadotropin-releasing GnRH agonist at least 4 weeks prior to start of study drug with histologically or cytologically confirmed diagnosis of HR+, HER2- unresectable or metastatic breast cancer that is not amenable to curative therapy.
* Had previous treatment for advanced or metastatic breast cancer with antiestrogen therapy including, but not limited to, selective estrogen receptor degraders (e.g., fulvestrant), selective estrogen receptor modulators (e.g., tamoxifen), and aromatase inhibitors (AI) (letrozole, anastrozole, exemestane)
* Part 1: Prior PI3Kα inhibitor treatment is allowed if taken for \< 14 days and not discontinued due to disease progression, hypersensitivity, or ≥ Grade 3 TEAEs.
Exclusion Criteria
* Type 1 or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥140 mg/dL and glycosylated hemoglobin (HbA1c) ≥7.0%.
18 Years
ALL
No
Sponsors
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Relay Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
Community Cancer Center North
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center-Main Campus
New York, New York, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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RLY-5836-101
Identifier Type: -
Identifier Source: org_study_id
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