Non-small Cell Lung Cancer Clinical Trial
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
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).
Status | Not yet recruiting |
Enrollment | 110 |
Est. completion date | December 30, 2027 |
Est. primary completion date | December 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | CHUM | Montréal | Quebec |
Canada | CIUSSS de l'Estrie - CHUS | Sherbrooke | Quebec |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | University of Chicago | Chicago | Illinois |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Hoag Hospital | Irvine | California |
United States | UPMC Hillman Cancer Center Research Pavilion | Pittsburgh | Pennsylvania |
United States | Washington University in St. Louis | Saint Louis | Missouri |
United States | University of Washington/Fred Hutchinson Cancer Center | Seattle | Washington |
United States | Stanford Hospital and Clinics | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Fusion Pharmaceuticals Inc. | AstraZeneca |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068 | • Incidence of Adverse Events and evaluation of dosimetry | Approximately 4 years post final administration | |
Primary | Radiation dose of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest. | For Part A, evaluate the impact of pre-dose administration of FPI-2053 on the radiation dosimetry of [111In]-FPI-2107 (whole body, organs, and selected regions of interest)
Estimate the effect of pre-dose administration of FPI-2053 on the radiation dosimetry of [225Ac]-FPI-2068 (whole body, organs, and selected regions of interest) |
Within 56 days of administration | |
Primary | Maximum tolerated dose of [225Ac]-FPI-2068 and FPI-2053 | Determine the RP2D of [225Ac]-FPI-2068, given with or without FPI-2053 | 56 days post administration | |
Secondary | Assess preliminary anti-tumor activity of [225Ac]-FPI-2068 | • Tumour assessments will be based on RECIST v1.1 (Eisenhauer et al, 2009) and will be performed approximately every 8 weeks (± 1 week) after the first [225Ac]-FPI-2068 dose, or as clinically indicated. | Approximately 4 years post final administration | |
Secondary | Tumor uptake of [111In]-FPI-2107 | • Tumor uptake of [111In]-FPI-2107 in selected regions of interest on SPECT/CT and/or planar images | Approximately 56 days of final administration | |
Secondary | Pharmacokinetics (PK) of [111In]-FPI-2107, and [225Ac]-FPI-2068, by measuring changes in clearance, AUC, Cmax, and half-life. | • Determine the plasma concentrations and PK parameters of [111In]-FPI-2107, and [225Ac]-FPI-2068 and the effect of pre-dose administration of FPI-2053 on the plasma concentrations and PK parameters of [111In]-FPI-2107. | Approximately 56 days of final administration | |
Secondary | To assess the immunogenicity of [111In]-FPI-2107, [225Ac]-FPI-2068, and FPI-2053 | • Presence of ADA for [111In]-FPI-2107, [225Ac]-FPI-2068, and FPI-2053 | Approximately 56 days of final administration |
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