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fusionpharmaceuticalsinc

A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

Description:

This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of [225Ac]-FPI-2068, [111In]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC).

Contacts:

Clinical Trials Fusion Pharmaceuticals Clinical Operations

clinicaltrials@fusionpharma.com

1 (888) 506-4215

Inclusion
  • Adequate organ function
  • Histologically/cytologically confirmed solid tumor, metastatic, locally advanced recurrent or inoperable
  • Measurable diseases as defined by RECIST v1.1
  • Progressed disease despite treatment, standard therapy not available contradicted not tolerable or no standard therapy
  • ECOG performance status 0 or 1
Exclusion
  • Prior anti-cancer therapy unless adequate washout and recovery from toxicities
  • Previous treatment with any systemic radiopharmaceutical
  • Uncontrolled pleural effusion, pericardial effusion, ascites requiring drainage
  • Contraindications to or inability perform the imaging procedures required in study
  • Radiation therapy within 28 days prior to the first dose of Indium

Patient Education


Patient Education Not Yet Provided

Publications


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Locations


United States 🇺🇸

Stanford University Medical Center

Stanford, California 94305, United States

Principal Investigator

Andrei Iagaru, MD

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Washington University School of Medicine

St. Louis, Missouri, United States

Principal Investigator

Richard Wahl, MD


University of Chicago

Chicago, Illinois 60637, United States

Principal Investigator

Aditya Juloori, MD


University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington 98109, United States

Principal Investigator

Delphine Chen, MD


M D Anderson Cancer Center

Houston, Texas 77030, United States

Principal Investigator

Jordi Rodon Ahnert, MD


Dana-Farber Cancer Institute

Boston, Massachusetts 02215, United States

Principal Investigator

Heather Jacene, MD


UPMC Hillman Cancer Center Research Pavilion

Pittsburgh, Pennsylvania 15213, United States


Afghanistan 🇦🇫

CIUSSS de l'Estrie - CHUS

Principal Investigator

Éric Turcotte, MD

Canada 🇨🇦

CHUM - Centre hospitalier de l'Université de Montréal

H2X 3E4, Montréal, Quebec, Canada

Principal Investigator

Daniel Juneau, MD

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