[225Ac]-FPI-2068 for Cancer

Recruiting at 13 trial locations

Overseen By Clinical Trials Fusion Pharmaceuticals Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Fusion Pharmaceuticals Inc.

Must not be taking: Systemic radiopharmaceuticals

Disqualifiers: CNS metastases, Uncontrolled effusions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

110 Participants Needed

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.

Research Team

Lorraine Hughes, MS

Principal Investigator

Fusion Pharmaceuticals Inc.

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.

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

Treatment Details

Interventions

• [111In]-FPI-2107
• [225Ac]-FPI-2068
• FPI-2053

Trial Overview 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.

Participant Groups

Group I: Dose Exploration and Dose Escalation Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

Fusion Pharmaceuticals Inc.

Lead Sponsor

Trials

6

Recruited

590+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology