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

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

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-130

SponsorAstraZeneca

About this trial

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).

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

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

Treatment groups

70 Participants

are divided into 1 treatment group

Locations

Canada

Research SiteT6G 1Z2, EdmontonAlberta, Canada

Research SiteB3H 2Y9, HalifaxNova Scotia, Canada

Research SiteH2X 0A9, MontrealQuebec, Canada

Research SiteJ1H 5N4, SherbrookeQuebec, Canada

Sponsors and collaborators

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov