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

RecruitingPhase 1/2

First-in-human Study of ATX-898, as Monotherapy and in Combination With Other Anti-neoplastic Agents, in Participants With Advanced Solid Tumors

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Has histologically or cytologically confirmed advanced solid tumor malignancy that is metastatic or locally advanced and unresectable
* Is ≥18 years of age at the time of signing the informed consent form
* ECOG performance status score of 0 or 1
* Adequate organ function
* Must consent to a pre-treatment tumor biopsy (collected during screening or have available archival tumor tissue in the past 5 years.

For Part 1a (monotherapy dose escalation)

* Has received one or more standard systemic therapies and additional standard therapies are either not available, or participant ineligible for available standard therapies For Part 1b (monotherapy dose expansion)
* b1: Has platinum-resistant or refractory metastatic ovarian cancer
* b2: Has recurrent or metastatic gynecologic cancer excluding the cancers eligible for b1
* b3: Has recurrent advanced or metastatic solid tumor excluding the cancers eligible for b1 or b2
* Has at least 1 measurable lesion per RECIST 1.1

For Part 2a (combination dose escalation)

* Has confirmed HR+ HER2 - (including HER2 low and ultra low) status
* Has received prior therapy in the metastatic For Part 2b (combination dose expansion)
* Has confirmed HR+ HER2 - (including HER2 low and ultra low) status
* Treatment-naïve or has received prior therapy in the metastatic setting

Exclusion Criteria:

* Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancer being studied
* Has symptomatic CNS metastases at screening or asymptomatic CNS metastases requiring corticosteroids to control symptoms within 28 days prior to the first dose of ATX-898.
* Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, with the exception of alopecia any grade and Grade ≤2 peripheral neuropathy
* Has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant or would prevent, limit, or confound the protocol-specified assessments

Cohort Specific:

* For abemaciclib cohorts only: has a history of any events of cardiac etiology that would contraindicate dosing with abemaciclib
* For ribocicilib only: has history of pneumonitis or interstitial lung disease

About the study

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.

What is being tested

Sponsor: Antares Therapeutics, Inc · Participants: 343 · Started: Aug 31, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07767474

Locations in the U.S.

TexasSTART Dallas Fort Worth Cancer Center, Fort Worth
MD Anderson Cancer Center, Houston
START San Antonio Cancer Center, San Antonio
UtahSTART Mountain Region Cancer Center, West Valley City
VirginiaNEXT Virginia Cancer Center- Merrifield Tech Center, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.