A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumours
Pancreatic Ductal Adenocarcinoma | Advanced Solid Tumor | Non-small Cell Lung...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).
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
Key Inclusion Criteria:
Histologically and/or cytologically confirmed solid tumor that is metastatic, locally advanced, recurrent or inoperable.
Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the participant refuses standard therapy.
Measurable disease as defined by RECIST Version 1.1
ECOG Performance status of 0 or 1
Adequate organ function
Key Exclusion Criteria:
Previous treatment with any systemic radiopharmaceutical
Prior anti-cancer therapy unless adequate washout and recovery from toxicities
Contraindications to or inability to perform the imaging procedures required in this study
Radiation therapy (RT) within 28 days prior to the first dose of \[111In\]-FPI-2107
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month)
Patients with known CNS metastatic disease unless treated and stable
Lieu de l'étude
CIUSSS de l'Estrie - CHUS
CIUSSS de l'Estrie - CHUSSherbrooke, Quebec
Canada
Contactez l'équipe d'étude
Michel Pavic, MD
Éric Turcotte, MD
CHUM
CHUMMontréal, Quebec
Canada
Contactez l'équipe d'étude
Daniel Juneau, MD
Cross Cancer Institute
Cross Cancer InstituteEdmonton, Alberta
Canada
Contactez l'équipe d'étude
Stella Koumna, MD
Queen Elizabeth II Health Sciences Centre| Nova Scotia Health Authority
Queen Elizabeth II Health Sciences Centre| Nova Scotia Health AuthorityHalifax, Nova Scotia
Canada
Contactez l'équipe d'étude
- Étude parrainée par
- Fusion Pharmaceuticals Inc.
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT06147037