ATX-898 for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
Study ATX-898-101 is a phase 1/2 open-label study evaluating the safety, tolerability, pharmacokinetic, and preliminary efficacy of ATX-898 as monotherapy and in combination with anti-neoplastic agents in selected solid tumors. This study consists of 2 parts. Part 1 evaluates ATX-898 as monotherapy and Part 2 evaluates ATX-898 in combination with anti-neoplastic agents of interest. Both parts will consists of a dose escalation portion and a dose expansion portion.
Are You a Good Fit for This Trial?
This trial is for adults (18+) with advanced or metastatic solid tumors, including breast cancer, who can't have surgery and whose disease has not responded to standard treatments. Participants must be in good physical condition and have working major organs. A recent tumor sample is required.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- ATX-898
Trial Overview
The study tests a new drug called ATX-898 alone and combined with other cancer drugs like fulvestrant or ribociclib. It aims to find the safest dose and see how well these treatments work against advanced solid tumors.
How Is the Trial Designed?
8
Treatment groups
Experimental Treatment
ATX-898 will be given at a recommended dose for expansion (RDE) in combination with fulvestrant and ribociclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer
ATX-898 will be given at a recommended dose for expansion (RDE) in combination with fulvestrant and abemaciclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer
ATX-898 will be given at a recommended starting dose in combination with fulvestrant and ribociclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer Subsequent dose regimen of ATX-898 will be determined during study execution
ATX-898 will be given at a recommended starting dose in combination with fulvestrant and abemaciclib both at the protocol defined doses for the treatment of participants with advanced or metastatic HR+HER2- breast cancer. Subsequent dose regimen of ATX-898 will be determined during study execution
ATX-898 will be given at the recommended dose for expansion (RDE) for the treatment of participants with selected advanced or metastatic solid tumors other than gynecologic cancers
ATX-898 will be given at the recommended dose for expansion (RDE) for the treatment of participants with selected advanced or metastatic gynecologic cancers other than ovarian cancers
ATX-898 will be given at the recommended dose for expansion (RDE) for the treatment of participants with selected advanced or metastatic ovarian cancer
ATX-898 will be given at a protocol defined starting dose for the treatment of participants with selected advanced or metastatic solid tumors. Subsequent dose regimen will be determined during study execution
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Who Is Running the Clinical Trial?
Antares Therapeutics, Inc
Lead Sponsor
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