NCT06147037

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
23mo left

Started Jul 2024

Typical duration for phase_1

Geographic Reach
2 countries

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jul 2024May 2028

First Submitted

Initial submission to the registry

November 20, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2028

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

3.8 years

First QC Date

November 20, 2023

Last Update Submit

May 22, 2026

Conditions

Advanced Solid TumorHead and Neck Squamous Cell CarcinomaMetastatic Colorectal CarcinomaNon-small Cell Lung CancerPancreatic Ductal AdenocarcinomaGastric CancerRenal Cell Carcinoma

Keywords

FPI-2068FPI-2107FPI-2053Actinium-225225AcIndium-111111InSolid tumorsTargeted alpha therapyTATEpidermal growth factor receptorEGFRMesenchymal-epithelial transition factorcMETBispecific antibodyRadioimmuno-SPECT agentRadioimmuno-therapeutic agentMonoclonal antibodyBifunctional chelating agentRadiopharmaceutical therapyAlpha particle emitterDirected bispecific monovalent antibodybsAbBifunctional chelatemCRCHNSCCNSCLCPDACGCRCCRLTRadioligand TherapyEGFRmEGFRwt

Outcome Measures

Primary Outcomes (4)

  • Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068

    Frequency, duration, and severity of AEs, DLTs, and changes in clinical, laboratory, and ECG parameters compared to baseline

    From informed consent up to approximately 5 years post last administration

  • Determine radiation dose of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest.

    Changes in uptake of \[111In\]-FPI-2107 and projected RAD of \[225Ac\]-FPI-2068 by imaging following the administration of varying doses of FPI-2053

    Within 56 days of administration

  • Determine the RP2D of [225Ac]-FPI-2068, given with or without FPI-2053

    Estimates of residence time and absorbed radiation doses to the whole body, organs, and selected regions of interest for \[111In\]-FPI-2107 and \[225Ac\]-FPI-2068.

    56 days post administration

  • Determine the effect of predose administration of varying doses of FPI-2053 on the radiation dosimetry of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest.

    Changes in uptake of \[111In\]-FPI- 2107 and projected RAD of \[225Ac\]-FPI-2068 by imaging following the administration of varying doses of FPI-2053

    56 days post-administration

Secondary Outcomes (4)

  • Assess preliminary anti-tumor activity of [225Ac]-FPI-2068

    Approximately 5 years post final administration

  • Tumor uptake of [111In]-FPI-2107

    Within 56 days of administration

  • Pharmacokinetics (PK) of [111In]-FPI-2107, and [225Ac]-FPI-2068, by measuring changes in clearance, AUC, Cmax, and half-life.

    From first dose of investigation product until 56 days after the last dose of investigational product.

  • To assess the immunogenicity of [111In]-FPI-2107, [225Ac]-FPI-2068, and FPI-2053

    From first dose of investigation product until 56 days after the last dose of investigational product.

Study Arms (1)

Dose Exploration and Dose Escalation

EXPERIMENTAL

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.

Drug: FPI-2053Drug: [111In]-FPI-2107Drug: [225Ac]-FPI-2068

Interventions

FPI-2053DRUG

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

Dose Exploration and Dose Escalation
[111In]-FPI-2107DRUG

\[111In\]-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).

Dose Exploration and Dose Escalation
[225Ac]-FPI-2068DRUG

\[225Ac\]-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.

Dose Exploration and Dose Escalation

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Site

Irvine, California, 92618, United States

WITHDRAWN

Research Site

Palo Alto, California, 94304, United States

RECRUITING

Research Site

Santa Monica, California, 90404, United States

NOT YET RECRUITING

Research Site

Chicago, Illinois, 60637, United States

RECRUITING

Research Site

Boston, Massachusetts, 02215, United States

RECRUITING

Research Site

St Louis, Missouri, 63110, United States

WITHDRAWN

Research Site

Omaha, Nebraska, 68130, United States

RECRUITING

Research Site

Cleveland, Ohio, 44195, United States

RECRUITING

Research Site

Pittsburgh, Pennsylvania, 15237, United States

WITHDRAWN

Research Site

Houston, Texas, 77030, United States

RECRUITING

Research Site

Seattle, Washington, 98109, United States

RECRUITING

Research Site

Edmonton, Alberta, T6G 1Z2, Canada

NOT YET RECRUITING

Research Site

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

Research Site

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

Research Site

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsSquamous Cell Carcinoma of Head and NeckCarcinoma, Non-Small-Cell LungStomach NeoplasmsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeHead and Neck NeoplasmsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesStomach DiseasesAdenocarcinomaKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 27, 2023

Study Start

July 31, 2024

Primary Completion (Estimated)

May 12, 2028

Study Completion (Estimated)

May 12, 2028

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

CA(4)US(11)