RecruitingPhase 1NCT06147037

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

A Phase 1, First-in-human, Multicentre, Open-label, Dose Escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours


Sponsor

AstraZeneca

Enrollment

70 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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, GC, RCC).


Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study tests a new radioactive cancer drug called [225Ac]-FPI-2068, which uses radioactive actinium to deliver targeted radiation directly to solid tumor cells. It is designed for adults with advanced cancers that have not responded to standard therapies. **You may be eligible if...** - You have a confirmed solid tumor (cancer) that has spread, cannot be surgically removed, or has returned after prior treatment - Your cancer has no effective standard treatment options remaining - You have measurable disease on imaging - Your overall health status is good (ECOG 0 or 1) - Your organ function is adequate **You may NOT be eligible if...** - You have previously received any radioactive drug (radiopharmaceutical) therapy - You received recent radiation treatment (within 28 days) - You have an uncontrolled fluid buildup around the lungs, heart, or abdomen - You have untreated or actively growing brain metastases - You cannot undergo the required imaging procedures - You have not recovered from prior cancer treatment side effects Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFPI-2053

FPI-2053 is a bispecific antibody that targets EGFR and cMET

DRUG[111In]-FPI-2107

\[111In\]-FPI-2107 is an imaging agent in which indium-111 is conjugated to FPI-2053. Participants will have a fixed dose of \[111In\]-FPI-2107 followed by imaging scans (with or without pre-administration of FPI-2053).

DRUG[225Ac]-FPI-2068

\[225Ac\]-FPI-2068 is a radiopharmaceutical therapy in which an alpha emitter, actinium-225, is conjugated to FPI-2053. Participants will be dosed through IV administration every 56 days for up to 3 cycles of the Treatment Period.


Locations(15)

Research Site

Irvine, California, United States

Research Site

Palo Alto, California, United States

Research Site

Santa Monica, California, United States

Research Site

Chicago, Illinois, United States

Research Site

Boston, Massachusetts, United States

Research Site

St Louis, Missouri, United States

Research Site

Omaha, Nebraska, United States

Research Site

Cleveland, Ohio, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Houston, Texas, United States

Research Site

Seattle, Washington, United States

Research Site

Edmonton, Alberta, Canada

Research Site

Halifax, Nova Scotia, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Sherbrooke, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT06147037


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