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NCT07767474

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

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Aún no reclutando Fase 1

Descripción

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.

Evidencia de la diana molecular en cáncer colorrectal

Aún no hay evidencia documentada en nuestra base para la diana o el fármaco de este ensayo. Esta sección crece a medida que se procesan nuevas publicaciones.

Criterios de Elegibilidad

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

Información del Ensayo

NCT07767474
Aún no reclutando
Fase 1
343 participantes
Ago 2026
Oct 2028