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

NCT ID: NCT06147037

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2028-05-12

Brief Summary

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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).

Detailed Description

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The study will be conducted in 2 parts:

Part A: optimization of the FPI-2053 dose (treatment with dose level 1 of \[225Ac\]-FPI-2068 - fixed dose).

Part B: dose escalation of \[225Ac\]-FPI-2068 with optimal FPI-2053. Part B will commence once the optimal dose of FPI-2053 is determined in Part A. The RP2D will be determined from Part B based on all available safety, efficacy, PK, and dosimetry information.

Conditions

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Advanced Solid Tumor Metastatic Colorectal Carcinoma Head and Neck Squamous Cell Carcinoma Non-small Cell Lung Cancer Pancreatic Ductal Adenocarcinoma Gastric Cancer Renal Cell Carcinoma

Keywords

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FPI-2068 FPI-2107 FPI-2053 Actinium-225 225Ac Indium-111 111In Solid tumors Targeted alpha therapy TAT Epidermal growth factor receptor EGFR Mesenchymal-epithelial transition factor cMET Bispecific antibody Radioimmuno-SPECT agent Radioimmuno-therapeutic agent Monoclonal antibody Bifunctional chelating agent Radiopharmaceutical therapy Alpha particle emitter Directed bispecific monovalent antibody bsAb Bifunctional chelate mCRC HNSCC NSCLC PDAC GC RCC RLT Radioligand Therapy EGFRm EGFRwt

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Exploration and Dose Escalation

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.

Group Type EXPERIMENTAL

FPI-2053

Intervention Type DRUG

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

[111In]-FPI-2107

Intervention Type DRUG

\[111In\]-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).

[225Ac]-FPI-2068

Intervention Type DRUG

\[225Ac\]-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.

Interventions

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FPI-2053

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

Intervention Type 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).

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Histologically and/or cytologically confirmed solid tumor that is metastatic, locally advanced, recurrent or inoperable.

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.

Measurable disease as defined by RECIST Version 1.1

ECOG Performance status of 0 or 1

Adequate organ function

Exclusion Criteria

Previous treatment with any systemic radiopharmaceutical

Prior anti-cancer therapy unless adequate washout and recovery from toxicities

Contraindications to or inability to perform the imaging procedures required in this study

Radiation therapy (RT) within 28 days prior to the first dose of \[111In\]-FPI-2107

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month)

Patients with known CNS metastatic disease unless treated and stable
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Irvine, California, United States

Site Status WITHDRAWN

Research Site

Palo Alto, California, United States

Site Status RECRUITING

Research Site

Santa Monica, California, United States

Site Status NOT_YET_RECRUITING

Research Site

Chicago, Illinois, United States

Site Status RECRUITING

Research Site

Boston, Massachusetts, United States

Site Status RECRUITING

Research Site

St Louis, Missouri, United States

Site Status WITHDRAWN

Research Site

Omaha, Nebraska, United States

Site Status RECRUITING

Research Site

Cleveland, Ohio, United States

Site Status RECRUITING

Research Site

Pittsburgh, Pennsylvania, United States

Site Status WITHDRAWN

Research Site

Houston, Texas, United States

Site Status RECRUITING

Research Site

Seattle, Washington, United States

Site Status RECRUITING

Research Site

Edmonton, Alberta, Canada

Site Status NOT_YET_RECRUITING

Research Site

Halifax, Nova Scotia, Canada

Site Status NOT_YET_RECRUITING

Research Site

Montreal, Quebec, Canada

Site Status RECRUITING

Research Site

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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FPI-2068-101

Identifier Type: -

Identifier Source: org_study_id