A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

PHASE1RecruitingINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

July 31, 2024

Primary Completion Date

December 30, 2026

Study Completion Date

December 30, 2027

Conditions
Advanced Solid TumorMetastatic Colorectal CarcinomaHead and Neck Squamous Cell CarcinomaNon-small Cell Lung CancerPancreatic Ductal AdenocarcinomaGastric CancerRenal Cell Carcinoma
Interventions
DRUG

FPI-2053

FPI-2053 is a bispecific antibody that targets EGFR and cMET

DRUG

[111In]-FPI-2107

"\[111In\]-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)."

DRUG

[225Ac]-FPI-2068

"\[225Ac\]-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."

Trial Locations (15)

15213

WITHDRAWN

UPMC Hillman Cancer Center Research Pavilion, Pittsburgh

44195

RECRUITING

Cleveland Clinic, Cleveland

60637

RECRUITING

University of Chicago, Chicago

63110

NOT_YET_RECRUITING

Washington University in St. Louis, St Louis

68130

RECRUITING

Nebraska Cancer Specialists, Omaha

77030

RECRUITING

MD Anderson Cancer Center, Houston

90404

NOT_YET_RECRUITING

UCLA Medical Center, Santa Monica

92618

COMPLETED

Hoag Hospital, Irvine

94305

RECRUITING

Stanford Hospital and Clinics, Stanford

98109

RECRUITING

University of Washington/Fred Hutchinson Cancer Center, Seattle

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

T6G 1Z2

NOT_YET_RECRUITING

Cross Cancer Institute, Edmonton

Nova Scotia

NOT_YET_RECRUITING

"Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority"

H2X 0C1

RECRUITING

CHUM, Montreal

J1H 5N4

RECRUITING

CIUSSS de l'Estrie - CHUS, Sherbrooke

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Fusion Pharmaceuticals Inc.

INDUSTRY