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RECRUITING
NCT07767474
PHASE1/PHASE2

A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors

Sponsor: Antares Therapeutics, Inc

View on ClinicalTrials.gov

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

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

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