[225Ac]-FPI-2068 for Cancer

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Fusion Pharmaceuticals Inc.

Must not be taking: Systemic radiopharmaceuticals

Disqualifiers: CNS metastases, Uncontrolled effusions, others

No Placebo Group

Trial Summary

What is the purpose of this trial?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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you must have an adequate washout period from prior anti-cancer therapy. This means you might need to stop certain treatments for a while before starting the trial.

Eligibility Criteria

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.

Inclusion Criteria

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

My organs are working well.

I am fully active or can carry out light work.

+3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Exploration (Part A)

Optimization of the FPI-2053 dose with a fixed dose of [225Ac]-FPI-2068

8 weeks

Visits as required for dose optimization

Dose Escalation (Part B)

Dose escalation of [225Ac]-FPI-2068 with optimal FPI-2053

8 weeks

Visits as required for dose escalation

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 4 years

Participant Groups

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.

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.