Trial Title:
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
NCT ID:
NCT05759949
Condition:
PIK3CA Mutation
Solid Tumor, Adult
HER2-negative Breast Cancer
Breast Cancer
Metastatic Breast Cancer
Advanced Breast Cancer
Unresectable Solid Tumor
Hormone Receptor Positive Tumor
Conditions: Official terms:
Neoplasms
Breast Neoplasms
Fulvestrant
Palbociclib
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RLY-5836
Description:
RLY-5836 is a mutant-selective, oral PI3Kα inhibitor.
Arm group label:
RLY-5836 + Abemaciclib + Fulvestrant Arm
Arm group label:
RLY-5836 + Fulvestrant Arm
Arm group label:
RLY-5836 + Palbociclib + Fulvestrant Arm
Arm group label:
RLY-5836 + Ribociclib + Fulvestrant Arm
Arm group label:
RLY-5836 Single Agent Arm
Intervention type:
Drug
Intervention name:
Fulvestrant
Description:
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.
Arm group label:
RLY-5836 + Abemaciclib + Fulvestrant Arm
Arm group label:
RLY-5836 + Fulvestrant Arm
Arm group label:
RLY-5836 + Palbociclib + Fulvestrant Arm
Arm group label:
RLY-5836 + Ribociclib + Fulvestrant Arm
Other name:
Faslodex
Intervention type:
Drug
Intervention name:
Palbociclib
Description:
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.
Arm group label:
RLY-5836 + Palbociclib + Fulvestrant Arm
Other name:
Ibrance
Intervention type:
Drug
Intervention name:
Ribociclib
Description:
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.
Arm group label:
RLY-5836 + Ribociclib + Fulvestrant Arm
Other name:
Kisqali
Intervention type:
Drug
Intervention name:
Abemaciclib
Description:
Abemaciclib 150 mg BID will be taken orally in combination with RLY-5836 and fulvestrant
for 28-day cycles.
Arm group label:
RLY-5836 + Abemaciclib + Fulvestrant Arm
Other name:
Verzenio
Summary:
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum
tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability,
pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in
advanced solid tumors in participants harboring a PIK3CA mutation in blood and/or tumor
per local assessment. The study consists of 2 parts, a dose escalation (Part 1) and a
dose expansion (Part 2).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patient has ECOG performance status of 0-1
One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor per
local assessment
RLY-5836 single agent arm key inclusion criteria
- 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
Combination arms key inclusion criteria
- 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:
- Part 2: Prior treatment with PI3Kα inhibitors.
- Type 1 or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma
glucose ≥140 mg/dL and glycosylated hemoglobin (HbA1c) ≥7.0%.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarah Cannon Research Institute at Florida Cancer Specialists
Address:
City:
Orlando
Zip:
32827
Country:
United States
Facility:
Name:
Community Cancer Center North
Address:
City:
Indianapolis
Zip:
46250
Country:
United States
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Cancer Center-Main Campus
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
Tennessee Oncology, PLLC
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Huntsman Cancer Institute, University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Start date:
March 29, 2023
Completion date:
July 25, 2024
Lead sponsor:
Agency:
Relay Therapeutics, Inc.
Agency class:
Industry
Source:
Relay Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05759949
