A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors
NCT07767474 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 343
Last updated 2026-08-17
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.
Conditions
Interventions
- DRUG
-
ATX-898
Doses defined per protocol
- DRUG
-
ATX-898
RDE
- DRUG
-
ATX-898
RDE
- DRUG
-
ATX-898
RDE
- DRUG
-
ATX-898
Doses defined per protocol
- DRUG
-
ATX-898, fulvestrant, ribociclib
ATX-898 at RDE, Fulvestrant and abemaciclib: doses defined per protocol
- DRUG
-
ATX-898, fulvestrant, ribociclib
ATX-898 at RDE, Fulvestrant and abemaciclib: doses defined per protocol
- DRUG
-
ATX-898, fulvestrant, ribociclib
Doses defined per protocol
Sponsors & Collaborators
-
Antares Therapeutics, Inc
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2028-10-28
- Completion
- 2030-01-31
- FDA Drug
- Yes
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