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A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
Trial Status: active
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, GC, RCC).
Inclusion Criteria
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
Additional locations may be listed on ClinicalTrials.gov for NCT06147037.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Approved
Name Not Available
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not Available
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.