Safety and Diagnostic Efficacy of 177Lu-AF03 in Patients With Solid Tumors

NCT07879547 · tracked via the Priya Life Science China tracker

Sponsor

Yong He

Phase

Early Phase 1

Started

2026-10-20

Last updated

2026-10-19

Condition(s) studied

Malignant Solid TumorsNeoplasms

Investigational drug(s) / intervention(s)

177Lu-AF03

177Lu-AF03: 177Lu-AF03 is a bispecific heterodimeric peptide radiolabeled with Lutetium-177, targeting both integrin αvβ6 and fibroblast activation protein (FAP). It is prepared by the Department of Nuclear Medicine, Zhongnan Hospital of Wuhan University, as an investigational agent and is not approved by any regulatory authority.

Study summary

This study evaluates 177Lu-AF03, a bispecific heterodimeric peptide targeting both FAP and integrin αvβ6, for safety, biodistribution, radiation dosimetry, and preliminary diagnostic efficacy in patients with malignant solid tumors. Preclinical studies showed enhanced tumor uptake, prolonged retention, and low uptake in non-target organs. Eight patients with confirmed malignant solid tumors will receive a single intravenous injection of 177Lu-AF03, followed by SPECT/CT imaging at multiple time points. Safety will be monitored until Day 7 post-injection.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Patients who voluntarily provide written informed consent prior to any study-specific procedure. * Patients with histologically (or cytologically) confirmed malignant solid tumors, treatment-naïve, with at least one measurable lesion (target lesion). * Age ≥18 and ≤75 years, male or female. * ECOG performance status 0 or 1. * Life expectancy ≥6 months. * Women of childbearing potential must have a negative pregnancy test, and all participants (including male participants) must agree to use effective contraception during the study and for at least 3 months after dosing. Exclusion Criteria: * Pregnant or lactating women, or women planning to become pregnant during the study or within 3 months after dosing (except those who are at least 1 year postmenopausal or surgically sterile \[e.g., bilateral tubal ligation without reversal, bilateral oophorectomy, or hysterectomy\]); or participants planning to donate sperm or oocytes during the study or within 3 months after dosing. * Known or suspected hypersensitivity to the investigational drug or any of its components. * Receipt of another investigational product at enrollment, or within 5 half-lives of that product or 30 days after its last dose, whichever is longer. * Use of any radiotherapeutic agent within 90 days before dosing, or any diagnostic radionuclide within 3 days before dosing. * Significant hepatic or renal impairment: total bilirubin (TBIL) \>1.5×ULN, or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5×ULN, or serum creatinine \>1.5×ULN. * Active infection at screening. * Inability to remain still and supine in the scanner for at least 30 min during SPECT, or claustrophobia or other conditions that preclude cooperation with SPECT. * Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.

Primary outcome measure(s)

Incidence and Severity of Adverse Events and Serious Adverse Events — Baseline through 1 month post-injection
Number of participants with adverse events and serious adverse events graded according to CTCAE v5.0 criteria from dosing through 1 month post-injection.
Organ Absorbed Dose of 177Lu-AF03 — Up to 168 hours post-injection
Organ absorbed doses (mGy/MBq) will be estimated from serial SPECT/CT imaging data using OLINDA software. Regions of interest will be drawn for major source organs to determine time-integrated activity coefficients.
Biodistribution of 177Lu-AF03 in Major Organs — Up to 168 hours post-injection
Biodistribution of 177Lu-AF03 will be assessed using serial SPECT/CT images. Regions of interest will be drawn for major organs (liver, kidney, spleen, red marrow, urinary bladder, and whole-body background) to determine radioactive retention (%ID/g or %ID/organ) at multiple time points post-injection.
Whole-Body Effective Dose of 177Lu-AF03 — Up to 168 hours post-injection
Whole-body effective dose (mSv/MBq) will be estimated from serial SPECT/CT imaging data using OLINDA software.

Trial sites (1)

Facility	City	Region	Status
Zhongnan Hospital of Wuhan University	Wuhan	Hubei

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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 NCT07879547 on ClinicalTrials.gov ↗ ← All trials in China