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

Launched by FUSION PHARMACEUTICALS INC. · Nov 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called [225Ac]-FPI-2068 for adults with certain advanced cancers, including metastatic colorectal cancer, head and neck cancer, non-small cell lung cancer, and pancreatic cancer. The main goal is to find out how safe the treatment is, how well it is tolerated by patients, and how it spreads in the body. The study is currently looking for participants who have cancer that has either come back after treatment or has not responded to standard therapies.

To be eligible, participants must have a confirmed diagnosis of a solid tumor that is difficult to treat and must have measurable disease, meaning their cancer can be tracked with imaging tests. They should also be in good general health, with a performance status of 0 or 1, which means they can carry out normal activities, and have functioning organs. Participants can expect to receive the treatment under careful monitoring and will undergo tests to evaluate how the drug affects their cancer and their overall health. It's important to note that certain previous treatments or health conditions may exclude some patients from joining the trial.

Gender

ALL

Eligibility 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