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


2024-07-31


2026-12-30


2027-12-30


110

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

2023-11-20  

N/A  

2025-05-09  

2023-11-20  

N/A  

2025-05-13  

2023-11-27  

N/A  

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/ArmIntervention/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 MeasuresMeasure DescriptionTime Frame
Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068• Incidence of Adverse Events and evaluation of dosimetryApproximately 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-2053Determine the RP2D of [225Ac]-FPI-2068, given with or without FPI-205356 days post administration
Secondary Outcome MeasuresMeasure DescriptionTime 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 imagesApproximately 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-2053Approximately 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:

    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

Collaborators and Investigators

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

  • AstraZeneca

  • 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