Trial Title:
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumours
NCT ID:
NCT06147037
Condition:
Advanced Solid Tumor
Metastatic Colorectal Carcinoma
Head and Neck Squamous Cell Carcinoma
Non-small Cell Lung Cancer
Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Carcinoma
Squamous Cell Carcinoma of Head and Neck
Colorectal Neoplasms
Conditions: Keywords:
FPI-2068
FPI-2107
FPI-2053
FPI-1784
Actinium-225
225Ac
Indium-111
111In
Solid tumors
Targeted alpha therapy
TAT
Epidermal growth factor receptor
EGFR
Mesenchymal-epithelial transition factor
cMET
Bispecific antibody
Radioimmuno-SPECT agent
Radioimmuno-therapeutic agent
Monoclonal antibody
Bifunctional chelating agent
Radiopharmaceutical therapy
Alpha particle emitter
Directed bispecific monovalent antibody
bsAb
Bifunctional chelate
mCRC
HNSCC
NSCLC
PDAC
RLT
Radioligand Therapy
EGFRm
EGFRwt
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FPI-2053
Description:
FPI-2053 is a bispecific antibody that targets EGFR and cMET
Arm group label:
Dose Exploration and Dose Escalation
Intervention type:
Drug
Intervention name:
[111In]-FPI-2107
Description:
[111In]-FPI-2107 is an imaging agent in which indium-111 is conjugated to FPI-2053.
Participants will have a fixed dose of [111In]-FPI-2107 followed by imaging scans (with
or without pre-administration of FPI-2053).
Arm group label:
Dose Exploration and Dose Escalation
Intervention type:
Drug
Intervention name:
[225Ac]-FPI-2068
Description:
[225Ac]-FPI-2068 is a radiopharmaceutical therapy in which an alpha emitter,
actinium-225, is conjugated to FPI-2053.
Participants will be dosed through IV administration every 56 days for up to 3 cycles of
the Treatment Period.
Arm group label:
Dose Exploration and Dose Escalation
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hoag Hospital
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Completed
Facility:
Name:
Stanford Hospital and Clinics
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
David Marcellus
Phone:
650-723-4547
Email:
dmarcel2@stanford.edu
Contact backup:
Last name:
Andrei Iagaru, MD
Facility:
Name:
University of Chicago
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Aditya Juloori, MD
Email:
ajuloori@uchicagomedicine.org
Contact backup:
Last name:
Veronika Seseri
Email:
vseseri@bsd.uchicago.edu
Contact backup:
Last name:
Aditya Juloori, MD
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Heather Jacene, MD
Phone:
617-632-3767
Email:
hjacene@bwh.harvard.edu
Contact backup:
Last name:
Kristen Harrington
Phone:
617-582-8218
Email:
KristenV_Harrington@dfci.harvard.edu
Contact backup:
Last name:
Heather Jacene, MD
Facility:
Name:
Washington University in St. Louis
Address:
City:
St. Louis
Zip:
63110
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Richard Wahl, MD
Phone:
314-747-9237
Email:
rwahl@wustl.edu
Contact backup:
Last name:
John Crandall
Phone:
314-747-5561
Email:
jcrandall@wustl.edu
Contact backup:
Last name:
Richard Wahl, MD
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Elcin Zan, MD
Phone:
216 894-8274
Email:
zane2@ccf.org
Contact backup:
Last name:
Wen Wee MA, MD
Phone:
216-442-0351
Email:
maw4@ccf.org
Contact backup:
Last name:
Elcin Zan, MD
Facility:
Name:
UPMC Hillman Cancer Center Research Pavilion
Address:
City:
Pittsburg
Zip:
15213
Country:
United States
Status:
Withdrawn
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jordi Rodon Ahnert, MD
Phone:
(713) 792-5603
Email:
JRodon@mdanderson.org
Contact backup:
Last name:
Yang Lu, MD
Phone:
(713) 792-5768
Email:
ylu10@mdanderson.org
Contact backup:
Last name:
Jordi Rodon Ahnert, MD
Facility:
Name:
University of Washington/Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Delphine Chen, MD
Phone:
206-606-6777
Email:
dlchen7@uw.edu
Contact backup:
Last name:
Heather White
Email:
hwhite@fredhutch.org
Contact backup:
Last name:
Delphine Chen, MD
Facility:
Name:
CHUM
Address:
City:
Montréal
Zip:
H2X 0C1
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Daniel Juneau, MD
Phone:
514-890-8180
Email:
daniel.juneau.med@ssss.gouv.qc.ca
Contact backup:
Last name:
Daniel Juneau, MD
Facility:
Name:
CIUSSS de l'Estrie - CHUS
Address:
City:
Sherbrooke
Zip:
J1H 5N4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Michel Pavic, MD
Phone:
8193461110
Phone ext:
74816
Email:
Michel.Pavic@USherbrooke.ca
Contact backup:
Last name:
Christine Lawson
Phone:
819-346-1110
Phone ext:
12942
Email:
christine.lawson.ciussse-chus@ssss.gouv.qc.ca
Contact backup:
Last name:
Éric Turcotte, MD
Contact backup:
Last name:
Michel Pavic, MD
Start date:
July 31, 2024
Completion date:
December 30, 2027
Lead sponsor:
Agency:
Fusion Pharmaceuticals Inc.
Agency class:
Industry
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Source:
Fusion Pharmaceuticals Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06147037
http://fusionpharma.com/
