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Phase 1/2Recruiting

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

First-in-human Study of ATX-898, as Monotherapy and in Combination With Other Anti-neoplastic Agents, in Participants With Advanced Solid Tumors

Sponsor
Antares Therapeutics, Inc (Industry)
Enrolment
343 planned
Conditions
Advanced Solid Tumors
Interventions
ATX-898; ATX-898; ATX-898; ATX-898; ATX-898; ATX-898, fulvestrant, ribociclib; ATX-898, fulvestrant, ribociclib; ATX-898, fulvestrant, ribociclib
Ages
adults, older adults
Registry
NCT07767474

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Part 1a monotherapy dose escalation - Occurrence of Dose limiting toxicities (DLTs)
  • Part 1a monotherapy dose escalation - Maximally tolerated/tested dose (MTD)
  • Part 1a monotherapy dose escalation - Recommended dose for expansion (RDE)
  • Part 1a monotherapy dose escalation - Treatment emergent adverse events (TEAEs)

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered