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NCT06147037 | RECRUITING | Advanced Solid Tumor

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

Fusion Pharmaceuticals Inc.

Brief Summary:

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).

Condition or disease

Advanced Solid Tumor

Metastatic Colorectal Carcinoma

Head and Neck Squamous Cell Carcinoma

Non-small Cell Lung Cancer

Pancreatic Ductal Adenocarcinoma

Intervention/treatment

FPI-2053

[111In]-FPI-2107

[225Ac]-FPI-2068

Phase

PHASE1

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 110 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-07-31
Estimated Primary Completion Date : 2026-12-30
Estimated Study Completion Date : 2027-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

Location Details

NCT06147037

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

COMPLETED

United States, California

Hoag Hospital

Irvine, California, United States, 92618

NOT YET RECRUITING

United States, California

UCLA Medical Center

Santa Monica, California, United States, 90404

NOT YET RECRUITING

United States, California

Stanford Hospital and Clinics

Stanford, California, United States, 94305

RECRUITING

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

NOT YET RECRUITING

United States, Missouri

Washington University in St. Louis

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, Nebraska

Nebraska Cancer Specialists

Omaha, Nebraska, United States, 68130

RECRUITING

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

WITHDRAWN

United States, Pennsylvania

UPMC Hillman Cancer Center Research Pavilion

Pittsburgh, Pennsylvania, United States, 15213

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Washington

University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

NOT YET RECRUITING

Canada, Alberta

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

NOT YET RECRUITING

Canada, New Scotia

Queen Elizabeth II Health Sciences Centre| Nova Scotia Health Authority

Halifax, Nova Scotia, Canada, B3H 1V7

RECRUITING

Canada, Quebec

CHUM

Montréal, Quebec, Canada, H2X 0C1

RECRUITING

Canada, Quebec

CIUSSS of the Story - CHUS

Sherbrooke, Quebec, Canada, J1H 5N4