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

Not Yet RecruitingPhase 1, Phase 2

Sponsor: Antares Therapeutics, Inc

Conditions: Advanced Solid Tumors

Interventions: ATX-898, ATX-898, ATX-898, ATX-898, ATX-898

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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