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

Trial ID: NCT06147037

Interventional - Phase 1 - Active, not recruiting

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).

Conditions

• 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

Interventions

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

Eligibility

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

Sponsor

AstraZeneca

Source: ClinicalTrials.gov

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