A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors
Sponsor: Antares Therapeutics, Inc
ClinicalTrials ID:NCT07767474
This phase 1/2 study assesses ATX-898's safety, tolerability, pharmacokinetics, and efficacy in advanced solid tumors. Eligibility includes adults with confirmed advanced tumors, ECOG 0-1, and adequate organ function. Part 1 explores monotherapy; Part 2 combines ATX-898 with anti-neoplastic agents. Interventions involve ATX-898 alone or with fulvestrant and ribociclib, with doses per protocol.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| START Dallas Fort Worth Cancer Center | 76104 | Fort Worth | Texas |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
| START San Antonio Cancer Center | 78229 | San Antonio | Texas |
| START Mountain Region Cancer Center | 84119 | West Valley City | Utah |
| NEXT Virginia Cancer Center- Merrifield Tech Center | 22031 | Fairfax | Virginia |
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