An Early Phase 1 interventional study of 177Lu-AF03 in Malignant Solid Tumors and Neoplasms, sponsored by Yong He. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Yong He · Early Phase 1, Interventional, and Diagnostic
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.
Background In our previous work, we developed a bispecific heterodimeric peptide, 68Ga-B6FA-01, targeting both FAP (on cancer-associated fibroblasts) and integrin αvβ6 (on tumor cells), and validated the effectiveness of this strategy. Preclinical and first-in-human studies demonstrated favorable imaging kinetics and safety. We further developed its corresponding therapeutic probe, 177Lu-AF03. Preclinical studies showed prolonged circulation, enhanced tumor retention, and low toxicity.
Objectives Primary objective: To evaluate the safety, tolerability, biodistribution, and radiation dosimetry of 177Lu-AF03.
Secondary objective: To assess the tumor lesion uptake efficacy of 177Lu-AF03 in patients with malignant solid tumors.
Study Design This is a prospective, single-center, single-arm, exploratory clinical study. A total of 8 treatment-naïve patients aged 18 to 75 years, male or female, with histologically (or cytologically) confirmed malignant solid tumors and at least one measurable lesion (target lesion) will be enrolled. After screening, enrollment, and signing informed consent, participants will undergo 177Lu-AF03 SPECT/CT imaging. A single intravenous injection of approximately 15-20 mCi 177Lu-AF03 will be administered, followed by SPECT/CT scans at multiple time points post-injection (4±1, 24±2, 48±3, and 168±4 hours). All participants will undergo safety visits on Day 7 (±1 day) and at 1 month (±3 days) post-injection. Adverse events and serious adverse events will be recorded from injection through the end of follow-up. This study has been approved by the Medical Ethics Committee of Zhongnan Hospital of Wuhan University (Approval No.: LINYANLUN[2026352]).
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 8 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Yong He is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with confirmed malignant solid tumors receive a single intravenous injection of about 15-20 mCi of 177Lu-AF03. SPECT/CT scan is performed at 4 ± 1 h, 24 ± 2 h, 48 ± 3 h, and 168 ± 4 h post-injection. Safety follow-up is performed on Day 7 (±1 day) and at 1 month (±3 days) post-injection.
Drug: 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.
Incidence and Severity of Adverse Events and Serious Adverse Events
Number of participants with adverse events and serious adverse events graded according to CTCAE v5.0 criteria from dosing through 1 month post-injection.
Time frame: Baseline through 1 month post-injection
Organ Absorbed Dose of 177Lu-AF03
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.
Time frame: Up to 168 hours post-injection
Biodistribution of 177Lu-AF03 in Major Organs
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.
Time frame: Up to 168 hours post-injection
Whole-Body Effective Dose of 177Lu-AF03
Whole-body effective dose (mSv/MBq) will be estimated from serial SPECT/CT imaging data using OLINDA software.
Time frame: Up to 168 hours post-injection
Semi-Quantitative Assessment of Tumor Uptake Using Standardized Uptake Value
177Lu-AF03 SPECT/CT images will be reconstructed using the ordered subset expectation maximization method with attenuation and scatter correction. Regions of interest will be drawn around tumor lesions to calculate standardized uptake values (SUV) as a semi-quantitative measure of tracer accumulation.
Time frame: Up to 168 hours post-injection
Qualitative Assessment of Tumor Uptake by Visual Analysis
177Lu-AF03 SPECT/CT images will be independently reviewed by two experienced nuclear medicine physicians blinded to other clinical data. Positive tumor uptake is defined as focal or diffuse increased tracer accumulation above surrounding normal tissue, after excluding physiological uptake in normal organs and tissues.
Time frame: Up to 168 hours post-injection
Plan to share: No — Individual participant data will not be shared because this is a small, single-center exploratory study. The data contain sensitive patient information and there is no plan for data sharing with other researchers at this time.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yong He