Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Carcinoma

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Lung Neoplasms

Squamous Cell Carcinoma of Head and Neck

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Antibodies, Bispecific

Immunoglobulins

Mitogens

Chelating Agents

Radiopharmaceuticals

The study conducted in two parts: Part A Dose Exploration and Part B Dose Escalation

FPI-2053 dose exploration to determine the optimal pre-dose administration of FPI-2053 with a fixed dose of \[225Ac\]-FPI-2068.

\[225Ac\]-FPI-2068 dose escalation with the optimal dose of FPI-2053 as determined in Part A.

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

FPI-2053

\[111In\]-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).

[111In]-FPI-2107

\[225Ac\]-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.

[225Ac]-FPI-2068

Clinical Trials Fusion Pharmaceuticals Clinical Operations

David Marcellus

Andrei Iagaru, MD

Aditya Juloori, MD

Veronika Seseri

Heather Jacene, MD

Kristen Harrington

Richard Wahl, MD

John Crandall

Jordi Rodon Ahnert, MD

Yang Lu, MD

Delphine Chen, MD

Heather White

Daniel Juneau, MD

Michel Pavic, MD

Christine Lawson

Éric Turcotte, MD

Lisa Jean-Louis

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).

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.

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

A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

• Incidence of Adverse Events and evaluation of dosimetry

* 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)

Determine the RP2D of \[225Ac\]-FPI-2068, given with or without FPI-2053

• 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.

• Tumor uptake of \[111In\]-FPI-2107 in selected regions of interest on SPECT/CT and/or planar images

• 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.

• Presence of ADA for \[111In\]-FPI-2107, \[225Ac\]-FPI-2068, and FPI-2053

AstraZeneca

Fusion Pharmaceuticals Inc.

Spots Global Cancer Trial Database for directed bispecific monovalent antibody