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Radiopharmaceutical

[225Ac]-FPI-2068 for Cancer

Phase 1

Recruiting

Research Sponsored by Fusion Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

ECOG Performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4 years post final administration

Awards & highlights

No Placebo-Only Group

Summary

This trial tests 3 drugs on people with cancer to measure safety, how drugs spread in body, and how body processes them.

Who is the study for?

This trial is for adults with advanced solid tumors like certain cancers of the mouth, pancreas, lung, and colorectal regions. Participants must have a confirmed diagnosis with disease progression after prior treatments and no available or suitable standard therapy options. They should be relatively active (good performance status) and have organs functioning well enough to handle the trial.

What is being tested?

The study is testing three experimental drugs: FPI-2053, [225Ac]-FPI-2068, and [111In]-FPI-2107. It's looking at how safe they are, what side effects occur, how the body processes them (pharmacokinetics), where they go in the body (biodistribution), and their radiation dosing in patients with metastatic or recurrent solid tumors.

What are the potential side effects?

As this is a first-in-human study for these drugs ([225Ac]-FPI-2068 specifically), potential side effects may include typical reactions to cancer medications such as nausea, fatigue, blood count changes but also could involve unique risks due to their radioactive nature which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition worsened after treatment and I can't or won't use standard therapies.

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I am fully active or can carry out light work.

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My cancer is confirmed to be advanced, recurrent, or cannot be removed by surgery.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4 years post final administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4 years post final administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years post final administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068

Maximum tolerated dose of [225Ac]-FPI-2068 and FPI-2053

Radiation dose of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest.

Secondary study objectives

Assess preliminary anti-tumor activity of [225Ac]-FPI-2068

Pharmacokinetics (PK) of [111In]-FPI-2107, and [225Ac]-FPI-2068, by measuring changes in clearance, AUC, Cmax, and half-life.

To assess the immunogenicity of [111In]-FPI-2107, [225Ac]-FPI-2068, and FPI-2053

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Exploration and Dose EscalationExperimental Treatment3 Interventions

The study conducted in two parts: Part A Dose Exploration and Part B Dose Escalation FPI-2053 dose exploration to determine the optimal pre-dose administration of FPI-2053 with a fixed dose of \[225Ac\]-FPI-2068. \[225Ac\]-FPI-2068 dose escalation with the optimal dose of FPI-2053 as determined in Part A.

0 / 4Eligibility criteria met