First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

Launched by RELAY THERAPEUTICS, INC. · Mar 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RLY-5836 for patients with advanced breast cancer and other solid tumors that have a specific change in their DNA known as a PIK3CA mutation. The trial is in its first phase, which means it’s the first time this treatment is being tested in people. The main goals are to find out the highest dose of RLY-5836 that can be safely given, how the body processes the drug, and whether it shows any signs of helping patients with their cancer. The study has two parts: the first part will gradually increase the dose to find the best level, while the second part will involve more patients receiving the recommended dose.

To be eligible for this trial, patients should be adults with certain types of advanced cancer that have not responded to standard treatments, or who cannot tolerate them. Specifically, they should have a PIK3CA mutation in their blood or tumor. Patients must also have a good overall health status and a confirmed diagnosis of advanced or metastatic solid tumors, such as breast cancer that cannot be surgically removed. Participants will receive RLY-5836 and will be monitored closely for any side effects and how well the treatment works. It's important to note that the trial is currently active but not recruiting new participants.

Gender

ALL

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%.