Malignant Solid TumorsEarly Phase 1NCT07879547
Safety and Diagnostic Efficacy of 177Lu-AF03 in Patients With Solid Tumors
A Early Phase 1 study testing 177Lu-AF03 in people with Malignant Solid Tumors and Neoplasms, run by Yong He at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Solid Tumors, Neoplasms
- What is being tested?
- 177Lu-AF03
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2026to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Yong He, MD, PhD, 027-67812837, heyong@whu.edu.cn
About this study
Official title: A Single-Arm, Open-Label, Exploratory Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy of a Novel SPECT Tracer 177Lu-AF03 in Patients With Malignant Solid Tumors
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.
Read the detailed description
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]).
- Conditions
- Malignant Solid Tumors, Neoplasms
- Being tested
- 177Lu-AF03
- Keywords
- integrin αVβ6, FAP, SPECT Imaging, Radiation dosimetry, 177Lu-AF03, Bispecific heterodimeric peptide, Biodistribution, Tumor uptake
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-AF03Drug
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 group | Role | What they receive |
|---|---|---|
| Patients with Malignant Solid Tumors | Experimental | 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. Receives: Drug: 177Lu-AF03 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 168 hours post-injection
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 168 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malignant Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive a single intravenous injection of about 15-20 mCi 177Lu-AF03, followed by SPECT/CT imaging at 4±1, 24±2, 48±3, and 168±4 hours post-injection. Safety visits will be performed on Day 7 (±1 day) and at 1 month (±3 days) post-injection. No randomization or blinding is applied.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yong He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong He, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879547
- Sponsor's protocol ID
- 202610AF_ZN
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Yang B, Shan C, Lin Z, Hu M, Qin C, Zeng D, An R, Lan X, Gai Y. Preparation and evaluation of a novel albumin-binding heterodimer therapeutic radiopharmaceutical with remarkable tumor accumulation and retention. Eur J Med Chem. 2025 Jun 5;290:117589. doi: 10.1016/j.ejmech.2025.117589. Epub 2025 Apr 1.
PubMed 40179612Quail DF, Joyce JA. Microenvironmental regulation of tumor progression and metastasis. Nat Med. 2013 Nov;19(11):1423-37. doi: 10.1038/nm.3394.
PubMed 24202395Huangfu Z, Yang J, Sun J, Xu B, Tao L, Wu J, Wang F, Wang G, Meng F, Zhong Z. PSMA and Sigma-1 receptor dual-targeted peptide mediates superior radionuclide imaging and therapy of prostate cancer. J Control Release. 2024 Nov;375:767-775. doi: 10.1016/j.jconrel.2024.09.040. Epub 2024 Oct 2.
PubMed 39332777
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Exploratory Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy of a Novel SPECT Tracer 177Lu-AF03 in Patients With Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07879547
- Acronym / sponsor ID
- 202610AF_ZN
- Conditions
- Malignant Solid Tumors, Neoplasms
- Keywords
- integrin αVβ6, FAP, SPECT Imaging, Radiation dosimetry, 177Lu-AF03, Bispecific heterodimeric peptide, Biodistribution, Tumor uptake
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Yong HeUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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]).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive a single intravenous injection of about 15-20 mCi 177Lu-AF03, followed by SPECT/CT imaging at 4±1, 24±2, 48±3, and 168±4 hours post-injection. Safety visits will be performed on Day 7 (±1 day) and at 1 month (±3 days) post-injection. No randomization or blinding is applied.
| Arm | Type | Receives |
|---|---|---|
| Patients with Malignant Solid Tumors | Experimental | Drug: 177Lu-AF03Patients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lu-AF03177Lu-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. | Drug | Patients with Malignant Solid Tumors |
Primary outcome
Incidence and Severity of Adverse Events and Serious Adverse Events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 168 hours post-injection
Whole-body effective dose (mSv/MBq) will be estimated from serial SPECT/CT imaging data using OLINDA software.
2 secondary outcomes
Semi-Quantitative Assessment of Tumor Uptake Using Standardized Uptake Value
Time frame: Up to 168 hours post-injection
Qualitative Assessment of Tumor Uptake by Visual Analysis
Time frame: Up to 168 hours post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 40179612Yang B, Shan C, Lin Z, Hu M, Qin C, Zeng D, An R, Lan X, Gai Y. Preparation and evaluation of a novel albumin-binding heterodimer therapeutic radiopharmaceutical with remarkable tumor accumulation and retention. Eur J Med Chem. 2025 Jun 5;290:117589. doi: 10.1016/j.ejmech.2025.117589. Epub 2025 Apr 1.
- Background: PubMed 24202395Quail DF, Joyce JA. Microenvironmental regulation of tumor progression and metastasis. Nat Med. 2013 Nov;19(11):1423-37. doi: 10.1038/nm.3394.
- Background: PubMed 39332777Huangfu Z, Yang J, Sun J, Xu B, Tao L, Wu J, Wang F, Wang G, Meng F, Zhong Z. PSMA and Sigma-1 receptor dual-targeted peptide mediates superior radionuclide imaging and therapy of prostate cancer. J Control Release. 2024 Nov;375:767-775. doi: 10.1016/j.jconrel.2024.09.040. Epub 2024 Oct 2.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 177Lu-AF03 in people with Malignant Solid Tumors and Neoplasms, run by Yong He at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong He (027-67812837, heyong@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events and Serious Adverse Events (time frame: Baseline through 1 month post-injection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07879547, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.