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

Study Overview

A Phase 1, 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).

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.

Advanced Solid Tumor
Metastatic Colorectal Carcinoma
Head and Neck Squamous Cell Carcinoma
Non-small Cell Lung Cancer
Pancreatic Ductal Adenocarcinoma

DRUG: FPI-2053
DRUG: [111In]-FPI-2107
DRUG: [225Ac]-FPI-2068

FPI-2068-101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-11-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-09
First Submitted that Met QC Criteria 2023-11-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-13
First Posted (ACTUAL) 2023-11-27	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dose Exploration and Dose Escalation 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	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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Dose Exploration and Dose Escalation

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

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.

Primary Outcome Measures	Measure Description	Time Frame
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
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
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 Outcome Measures	Measure Description	Time Frame
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
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
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
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Clinical Trials Fusion Pharmaceuticals Clinical Operations

Phone Number: 1 (888) 506-4215

Email: clinicaltrials@fusionpharma.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

AstraZeneca

Investigators

STUDY_DIRECTOR: Lorraine Hughes, MS, Fusion Pharmaceuticals Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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