ATX-898 in people with advanced solid tumors
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
Run by Antares Therapeutics, Inc · NCT07767474 · Data updated 2026-11-12
This study tests ATX-898 by itself and with other cancer drugs in adults with advanced solid tumors to see if it is safe and potentially effective.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 343 (estimated) |
| Sponsor | Antares Therapeutics, Inc Industry-sponsored |
| Locations | 6 sites (Fort Worth, Texas and 5 other locations) |
| Status | Recruiting |
| Started | August 31, 2026 |
| Main results expected | October 28, 2029 |
| Study ends | January 31, 2030 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07767474 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically confirmed advanced or unresectable solid tumors, measurable disease, ECOG 0-1, adequate organ function, and willing to provide tumor tissue for testing.
✕Probably not a fit
Patients with tumors unlikely to respond to ATX-898 or those who experience intolerable side effects may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
ATX-898-101 is a phase 1/2 open-label trial that explores safety, tolerability, how the drug behaves in the body, and preliminary signs of efficacy in patients with advanced solid tumors. The study has two parts: Part 1 looks at ATX-898 as a standalone treatment and Part 2 tests ATX-898 in combination with other anti-cancer agents. Each part includes a dose-escalation phase to identify a safe dose and a dose-expansion phase to further evaluate activity in specific tumor groups, including platinum-resistant ovarian cancer and other gynecologic or non-gynecologic cancers. Eligible participants are adults with measurable disease, adequate organ function, and a tumor biopsy available for testing.
Why it matters
Potential benefit: If successful, participants could experience tumor shrinkage or disease stabilization and may gain access to a novel therapy option.
How similar studies have gone: Earlier early-phase studies in similar targeted agents have shown signals of safety and potential activity, but this exact ATX-898 approach is still being explored in a 1/2 phase design.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
START Dallas Fort Worth Cancer Center
Fort Worth, Texas, United States Recruiting -
MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
START San Antonio Cancer Center
San Antonio, Texas, United States Recruiting -
START Mountain Region Cancer Center
West Valley City, Utah, United States Recruiting -
NEXT Virginia Cancer Center- Merrifield Tech Center
Fairfax, Virginia, United States Recruiting -
Linear Clinical Research
Perth, Western Australia, Australia Recruiting
Study contacts
- Study coordinator: Antares Medical Monitor
- Email: clinicaltrials@antaresrx.com
- Phone: +1 781-288-5760
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.