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Phase I/II, Multi Center, Open Label, First-in-human, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-tumors Efficacy of the Glyco-humanized Polyclonal Antibody XON7 in Patients With Advanced or Metastatic Solid Tumors

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Trial Profile

Phase I/II, Multi Center, Open Label, First-in-human, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-tumors Efficacy of the Glyco-humanized Polyclonal Antibody XON7 in Patients With Advanced or Metastatic Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 25 Jun 2025

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At a glance

  • Drugs XON-7 (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Colorectal cancer; Gastric cancer; Haematological malignancies; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Sarcoma; Solid tumours; Triple negative breast cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms FIPO23
  • Sponsors Xenothera

Most Recent Events

  • 16 Jan 2025 According to a Xenothera media release, company announces announced the start of the 16mg dose cohort in the FIPO trial, which has been validated by the trials Scientific Advisory Board and hree patients have already received this new dose. A final dose of 20mg is planned in the trial design before moving on to phase II.
  • 04 Jun 2024 Results (As of Feb 3rd, 2024, n=3 first dose cohort and have received XON7 at dose 1,5 mg/kg Q2W for the first 28-days cycle, presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
  • 01 Jun 2024 According to a Xenothera media release, to date, 3 dose levels have been tested and initiated. Recruitment of the third dose (6 mg/kg) is underway. The company has signed a euro 750,000 financing agreement with BPI France to grant the FIPO clinical trial.. This first round of funding will support the ascending phase of the trial, which began in November 2023 (first patient admitted) and should be completed by the end of 2024.

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