Health Trials

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

ConditionAdvanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAntares Therapeutics, Inc

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ATX-898
  • ATX-898
  • ATX-898
  • ATX-898
  • ATX-898
  • ATX-898, fulvestrant, ribociclib
  • ATX-898, fulvestrant, ribociclib
  • ATX-898, fulvestrant, ribociclib

Treatment groups

343 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators

Antares Therapeutics, Inc

Lead sponsor

Source ClinicalTrials.gov