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Clinical Trials in the USA / NCT06147037
Active, not recruiting Phase 1

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

NCT06147037 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 1
Started
2024-07-31
Last updated
2026-09-30

Condition(s) studied

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

Investigational drug(s) / intervention(s)

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

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

[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).

[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.

Study 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

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Key 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 Key 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

Primary outcome measure(s)

  • Evaluate safety and tolerability of [111In]-FPI-2107, FPI-2053, and [225Ac]-FPI-2068 — From informed consent up to approximately 5 years post last administration
    Frequency, duration, and severity of AEs, DLTs, and changes in clinical, laboratory, and ECG parameters compared to baseline
  • Determine radiation dose of [111In]-FPI-2107 and [225Ac]-FPI-2068 to whole body, organs, and selected regions of interest. — Within 56 days of administration
    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
  • Determine the RP2D of [225Ac]-FPI-2068, given with or without FPI-2053 — 56 days post administration
    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.
  • 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. — 56 days post-administration
    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

Trial sites (8)

FacilityCityRegionStatus
Research Site Palo Alto California
Research Site Chicago Illinois
Research Site Omaha Nebraska
Research Site Cleveland Ohio
Research Site Houston Texas
Research Site Seattle Washington
Research Site Montreal Quebec
Research Site Sherbrooke Quebec

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Other trials for the same condition

A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC) Active, not recruiting
MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients Active, not recruiting
A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer Active, not recruiting
Study of SGR-3515 In Participants With Advanced Solid Tumors. Recruiting
Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06147037 on ClinicalTrials.gov ↗ ← All trials in the USA