RECRUITING

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

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Conditions

Advanced Solid TumorMetastatic Colorectal CarcinomaHead and Neck Squamous Cell CarcinomaNon-small Cell Lung CancerPancreatic Ductal AdenocarcinomaGastric CancerRenal Cell CarcinomaFPI-2068FPI-2107FPI-2053FPI-1784Actinium-225225AcIndium-111111InSolid tumorsTargeted alpha therapyTATEpidermal growth factor receptorEGFRMesenchymal-epithelial transition factorcMETBispecific antibodyRadioimmuno-SPECT agentRadioimmuno-therapeutic agentMonoclonal antibodyBifunctional chelating agentRadiopharmaceutical therapyAlpha particle emitterDirected bispecific monovalent antibodybsAbBifunctional chelatemCRCHNSCCNSCLCPDACRLTRadioligand TherapyEGFRmEGFRwt

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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, GC, RCC).

Official Title

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

Quick Facts

Study Start:2024-07-31
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06147037

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Trials Fusion Pharmaceuticals Clinical Operations
CONTACT
1 (888) 506-4215
clinicaltrials@fusionpharma.com

Principal Investigator

Lorraine Hughes, MS
STUDY_DIRECTOR
Fusion Pharmaceuticals Inc.

Study Locations (Sites)

Hoag Hospital
Irvine, California, 92618
United States
UCLA Medical Center
Santa Monica, California, 90404
United States
Stanford Hospital and Clinics
Stanford, California, 94305
United States
University of Chicago
Chicago, Illinois, 60637
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Washington University in St. Louis
St Louis, Missouri, 63110
United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
UPMC Hillman Cancer Center Research Pavilion
Pittsburgh, Pennsylvania, 15213
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Fusion Pharmaceuticals Inc.

  • Lorraine Hughes, MS, STUDY_DIRECTOR, Fusion Pharmaceuticals Inc.

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

Study Start Date2024-07-31
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2024-07-31
Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

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