Spots Global Cancer Trial Database for A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
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Trial Identification
Brief Title: A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
Official Title: A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
Study ID: NCT06147037
Study Description
Brief Summary: 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).
Detailed Description: The study will be conducted in 2 parts: Part A: optimization of the FPI-2053 dose (treatment with dose level 1 of \[225Ac\]-FPI-2068 - fixed dose). Part B: dose escalation of \[225Ac\]-FPI-2068 with optimal FPI-2053. Part B will commence once the optimal dose of FPI-2053 is determined in Part A. The RP2D will be determined from Part B based on all available safety, efficacy, PK, and dosimetry information.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hoag Hospital, Irvine, California, United States
Stanford Hospital and Clinics, Stanford, California, United States
University of Chicago, Chicago, Illinois, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Washington University in St. Louis, Saint Louis, Missouri, United States
UPMC Hillman Cancer Center Research Pavilion, Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Washington/Fred Hutchinson Cancer Center, Seattle, Washington, United States
CHUM, Montréal, Quebec, Canada
CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada
Contact Details
Name: Lisa Jean-Louis
Affiliation: Fusion Pharmaceuticals Inc.
Role: STUDY_DIRECTOR
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