Not currently recruiting at University of California Health

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

a study on Solid Tumor Colorectal Cancer Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma Lung Cancer Non-Small Cell Lung Cancer Pancreatic Ductal Adenocarcinoma Carcinoma Head and Neck Cancer Colorectal Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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).

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

Details

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.

Keywords

Advanced Solid Tumor, Metastatic Colorectal Carcinoma, Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, 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, Carcinoma, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms, [111In]-FPI-2107, [225Ac]-FPI-2068

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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

Locations

  • UCLA Medical Center not yet accepting patients
    Santa Monica California 90404 United States
  • Hoag Hospital completed
    Irvine California 92618 United States
  • Stanford Hospital and Clinics not yet accepting patients
    Stanford California 94305 United States
  • University of Washington/Fred Hutchinson Cancer Center accepting new patients
    Seattle Washington 98109 United States
  • Nebraska Cancer Specialists accepting new patients
    Omaha Nebraska 68130 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Fusion Pharmaceuticals Inc.
Links
Sponsor Website
ID
NCT06147037
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 110 study participants
Last Updated