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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

Study 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.Check my eligibility

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.See study design

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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It seems like there might be some information missing from your request. Can you please provide more details or context so that I can assist you accurately?

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor

4,272 Previous Clinical Trials

288,612,565 Total Patients Enrolled

Fusion Pharmaceuticals Inc.Lead Sponsor

4 Previous Clinical Trials

416 Total Patients Enrolled

Lisa Jean-LouisStudy DirectorFusion Pharmaceuticals Inc.

2 Previous Clinical Trials

972 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have the FDA given sanction to Dose Exploration and Dose Escalation?

"As this is an early phase 1 trial, limited evidence supports the safety of Dose Exploration and Dose Escalation which warranted a score of 1."

Answered by AI

Are individuals able to join this clinical trial at the present time?

"Reportedly, this clinical trial is now defunct. It was first published on December 30th 2023 but has not been updated since November 27th of the same year; accordingly, it is no longer recruiting patients. Currently though, 4455 other medical studies are actively searching for participants."

Answered by AI

What is the ultimate purpose of this clinical experiment?

"According to Fusion Pharmaceuticals Inc., the sponsor of this trial, their primary outcome goal is ascertaining the Maximum tolerated dose of [225Ac]-FPI-2068 and FPI-2053 over a span of 4 years. The secondary objectives include evaluating Tumor uptake of [111In]-FPI-2107 using SPECT/CT or planar imaging as well as measuring changes in Pharmacokinetics parameters such as clearance, AUC, Cmax, and half-life post administration. Additionally, they aim to assess immunogenicity towards each drug through ADA testing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06147037.

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