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An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors Including Sarcomas

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Trial Profile

An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 27 Jun 2025

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At a glance

  • Drugs Ozekibart (Primary) ; Carboplatin; Cisplatin; Fluorouracil; Folinic acid; Irinotecan; Pemetrexed; Temozolomide
  • Indications Adenocarcinoma; Chondrosarcoma; Colorectal cancer; Ewing's sarcoma; Gastric cancer; Malignant-mesothelioma; Pancreatic cancer; Sarcoma; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Inhibrx

Most Recent Events

  • 21 Jan 2025 According to an Inhibrx Biosciences media release, from the Phase 1 preliminary results, company has initiated a new expansion cohort to validate these findings in a more uniform patient population. The cohort is expected to enroll up to 50 patients, each with two to three prior lines of systemic therapy, and data are anticipated in Q3 2025.
  • 21 Jan 2025 According to an Inhibrx Biosciences media release, preliminary efficacy and safety data from the Phase 1 trial of ozekibart (INBRX-109) in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma were published at the American Society of Clinical Oncology (ASCO) Gastrointestinal Annual Cancers Symposium.
  • 21 Jan 2025 Results presented in the Inhibrx Biosciences Media Release.

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