A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
AstraZeneca
70 participants
Jul 31, 2024
INTERVENTIONAL
Conditions
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, GC, RCC).
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria6
- 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
Interventions
FPI-2053 is a bispecific antibody that targets EGFR and cMET
\[111In\]-FPI-2107 is an imaging agent in which indium-111 is conjugated to FPI-2053. Participants will have a fixed dose of \[111In\]-FPI-2107 followed by imaging scans (with or without pre-administration of FPI-2053).
\[225Ac\]-FPI-2068 is a radiopharmaceutical therapy in which an alpha emitter, actinium-225, is conjugated to FPI-2053. Participants will be dosed through IV administration every 56 days for up to 3 cycles of the Treatment Period.
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT06147037