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A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors
Sponsor: Antares Therapeutics, Inc
Summary
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.
Official title: First-in-human Study of ATX-898, as Monotherapy and in Combination With Other Anti-neoplastic Agents, in Participants With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
343
Start Date
2026-08-31
Completion Date
2030-01-31
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
ATX-898
Doses defined per protocol
ATX-898
RDE
ATX-898
RDE
ATX-898
RDE
ATX-898
Doses defined per protocol
ATX-898, fulvestrant, ribociclib
ATX-898 at RDE, Fulvestrant and abemaciclib: doses defined per protocol
ATX-898, fulvestrant, ribociclib
ATX-898 at RDE, Fulvestrant and abemaciclib: doses defined per protocol
ATX-898, fulvestrant, ribociclib
Doses defined per protocol
Locations (6)
START Dallas Fort Worth Cancer Center
Fort Worth, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
START San Antonio Cancer Center
San Antonio, Texas, United States
START Mountain Region Cancer Center
West Valley City, Utah, United States
NEXT Virginia Cancer Center- Merrifield Tech Center
Fairfax, Virginia, United States
Linear Clinical Research
Perth, Western Australia, Australia