OsteosarcomaEarly Phase 1NCT07774533
68Ga-B7-H3 Nanobody ImmunoPET in Osteosarcoma
A Early Phase 1 study testing 68Ga-B7-H3 Nanobody PET/CT in people with Osteosarcoma and Osteosarcoma, Recurrent, Refractory, run by Peking University First Hospital at 1 site in China.
Trial summary
This study aims to evaluate the safety, feasibility, and imaging performance of a novel 68Ga-labeled B7-H3 nanobody for immunoPET imaging in patients with osteosarcoma. Participants with suspected or histologically confirmed osteosarcoma will undergo 68Ga-B7-H3 nanobody PET/CT imaging according to the study protocol. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Osteosarcoma, Osteosarcoma, Recurrent, Refractory
- What is being tested?
- 68Ga-B7-H3 Nanobody PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Sep 2026
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥10 years.
- Histologically confirmed osteosarcoma.
- Relapsed or refractory disease following failure of first- or second-line systemic therapy.
- Ability to understand the study procedures and provide written informed consent (or assent with parental/legal guardian consent, where applicable).
Who cannot join
- Pregnant or breastfeeding.
- Severe uncontrolled systemic disease or medical condition that, in the investigator's judgment, may interfere with study participation or image interpretation.
- Unable to undergo PET/CT examination.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
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, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Tingfei Gu, M.D, 010-83572913, tingfei.gu@stx.ox.ac.uk
About this study
Official title: Clinical Evaluation of a 68Ga-Labeled B7-H3 Nanobody for ImmunoPET Imaging in Patients With Osteosarcoma
This study aims to evaluate the safety, feasibility, and imaging performance of a novel 68Ga-labeled B7-H3 nanobody for immunoPET imaging in patients with osteosarcoma. Participants with suspected or histologically confirmed osteosarcoma will undergo 68Ga-B7-H3 nanobody PET/CT imaging according to the study protocol. Imaging findings will be compared with conventional imaging and, when available, histopathological results. The study will assess tracer biodistribution, tumor uptake, lesion detectability, and safety to determine the potential clinical value of B7-H3-targeted immunoPET for the diagnosis and evaluation of osteosarcoma.
Read the detailed description
B7-H3 (CD276) is an immune checkpoint molecule that is highly expressed in a variety of malignant tumors, including osteosarcoma, while showing limited expression in most normal tissues. Because of its high tumor-associated expression, B7-H3 has emerged as a promising molecular imaging and therapeutic target.
This is a prospective, single-center clinical study designed to evaluate a novel 68Ga-labeled B7-H3 nanobody as an immunoPET imaging agent in patients with osteosarcoma. Eligible participants will receive an intravenous administration of the investigational radiotracer followed by PET/CT imaging at the prespecified imaging time point(s). Safety assessments will include monitoring of adverse events and other clinically relevant evaluations as specified in the protocol.
Imaging findings will be analyzed to characterize tracer biodistribution and tumor uptake and will be compared with standard imaging examinations and histopathological findings whenever available. The study is intended to investigate the feasibility and diagnostic performance of 68Ga-B7-H3 nanobody immunoPET for the detection and evaluation of osteosarcoma and to provide clinical evidence supporting the further development of B7-H3-targeted molecular imaging.
- Conditions
- Osteosarcoma, Osteosarcoma, Recurrent, Refractory
- Being tested
- 68Ga-B7-H3 Nanobody PET/CT
- Keywords
- Osteosarcoma, B7-H3, CD276, ImmunoPET, Gallium-68, Nanobody, PET/CT, Molecular Imaging
- Medical subject headings
- Osteosarcoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-B7-H3 Nanobody PET/CTDiagnostic test
Participants with osteosarcoma will receive a single intravenous administration of the investigational 68Ga-labeled B7-H3 nanobody followed by PET/CT imaging according to the study protocol. Imaging findings will be analyzed for tracer biodistribution, tumor uptake, lesion detection, and safety.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-B7-H3 Nanobody PET/CT | Experimental | Participants with osteosarcoma will receive a single intravenous administration of the investigational 68Ga-labeled B7-H3 nanobody followed by PET/CT imaging according to the study protocol. Imaging findings will be analyzed for tracer biodistribution, tumor uptake, lesion detection, and safety. Receives: Diagnostic Test: 68Ga-B7-H3 Nanobody PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion detection rate of 68Ga-B7-H3 nanobody PET/CT
Number and proportion of osteosarcoma lesions detected by 68Ga-B7-H3 nanobody PET/CT, using histopathology and/or clinical follow-up as the reference standard.
Measured: Baseline (at the time of PET/CT imaging)
Number of participants with 68Ga-PFBH01-related adverse events
Number and proportion of participants experiencing one or more adverse events considered related to 68Ga-PFBH01 administration. Adverse events will be recorded from tracer administration through 30 ± 3 days after PET/CT and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
Measured: 30 ± 3 days
Secondary outcomes (1)
Maximum standardized uptake value (SUVmax) of 68Ga-PFBH01 in osteosarcoma lesions
SUVmax of 68Ga-PFBH01 will be measured in osteosarcoma lesions identified on PET/CT. SUVmax represents the maximum voxel-level standardized uptake value within the lesion region of interest.
Measured: At the time of PET/CT imaging ("Baseline")
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Apr 2026
- Primary completion5 Aug 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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 undergo 68Ga-B7-H3 nanobody PET/CT imaging following administration of the investigational radiotracer. This is a single-group, open-label imaging study without randomization or comparator arms.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774533
- Sponsor's protocol ID
- PFBH01
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article will be shared, including relevant clinical characteristics and quantitative PET/CT imaging data. Data that could compromise participant privacy will not be shared.
Publications
Qiu Y, Gu T, Wang T, Mulati Y, Sun X, Yang Q, Song L, Yuan T, Fan Y, Kang L, Cai W. Integrated radio-theranostics using a [89Zr]Zr-/[177Lu]Lu-labeled B7-H3 antibody-drug conjugate for prostate cancer. Theranostics. 2026 Apr 16;16(11):6132-6144. doi: 10.7150/thno.125878. eCollection 2026.
PubMed 42094601
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a 68Ga-Labeled B7-H3 Nanobody for ImmunoPET Imaging in Patients With Osteosarcoma
- ClinicalTrials.gov ID
- NCT07774533
- Acronym / sponsor ID
- PFBH01
- Conditions
- Osteosarcoma, Osteosarcoma, Recurrent, Refractory
- Keywords
- Osteosarcoma, B7-H3, CD276, ImmunoPET, Gallium-68, Nanobody, PET/CT, Molecular Imaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Aug 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 aims to evaluate the safety, feasibility, and imaging performance of a novel 68Ga-labeled B7-H3 nanobody for immunoPET imaging in patients with osteosarcoma. Participants with suspected or histologically confirmed osteosarcoma will undergo 68Ga-B7-H3 nanobody PET/CT imaging according to the study protocol. Imaging findings will be compared with conventional imaging and, when available, histopathological results. The study will assess tracer biodistribution, tumor uptake, lesion detectability, and safety to determine the potential clinical value of B7-H3-targeted immunoPET for the diagnosis and evaluation of osteosarcoma.
Detailed description
B7-H3 (CD276) is an immune checkpoint molecule that is highly expressed in a variety of malignant tumors, including osteosarcoma, while showing limited expression in most normal tissues. Because of its high tumor-associated expression, B7-H3 has emerged as a promising molecular imaging and therapeutic target.
This is a prospective, single-center clinical study designed to evaluate a novel 68Ga-labeled B7-H3 nanobody as an immunoPET imaging agent in patients with osteosarcoma. Eligible participants will receive an intravenous administration of the investigational radiotracer followed by PET/CT imaging at the prespecified imaging time point(s). Safety assessments will include monitoring of adverse events and other clinically relevant evaluations as specified in the protocol.
Imaging findings will be analyzed to characterize tracer biodistribution and tumor uptake and will be compared with standard imaging examinations and histopathological findings whenever available. The study is intended to investigate the feasibility and diagnostic performance of 68Ga-B7-H3 nanobody immunoPET for the detection and evaluation of osteosarcoma and to provide clinical evidence supporting the further development of B7-H3-targeted molecular imaging.
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 undergo 68Ga-B7-H3 nanobody PET/CT imaging following administration of the investigational radiotracer. This is a single-group, open-label imaging study without randomization or comparator arms.
| Arm | Type | Receives |
|---|---|---|
| 68Ga-B7-H3 Nanobody PET/CT | Experimental | Diagnostic Test: 68Ga-B7-H3 Nanobody PET/CTParticipants with osteosarcoma will receive a single intravenous administration of the investigational 68Ga-labeled B7-H3 nanobody followed by PET/CT imaging according to the study protocol. Imaging findings will be analyzed for tracer biodistribution, tumor uptake, lesion detection, and safety. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥10 years.
- Histologically confirmed osteosarcoma.
- Relapsed or refractory disease following failure of first- or second-line systemic therapy.
- Ability to understand the study procedures and provide written informed consent (or assent with parental/legal guardian consent, where applicable).
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding.
- Severe uncontrolled systemic disease or medical condition that, in the investigator's judgment, may interfere with study participation or image interpretation.
- Unable to undergo PET/CT examination.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
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 |
|---|---|---|
| 68Ga-B7-H3 Nanobody PET/CTParticipants with osteosarcoma will receive a single intravenous administration of the investigational 68Ga-labeled B7-H3 nanobody followed by PET/CT imaging according to the study protocol. Imaging findings will be analyzed for tracer biodistribution, tumor uptake, lesion detection, and safety. | Diagnostic test | 68Ga-B7-H3 Nanobody PET/CT |
Primary outcome
Lesion detection rate of 68Ga-B7-H3 nanobody PET/CT
Time frame: Baseline (at the time of PET/CT imaging)
Number and proportion of osteosarcoma lesions detected by 68Ga-B7-H3 nanobody PET/CT, using histopathology and/or clinical follow-up as the reference standard.
Number of participants with 68Ga-PFBH01-related adverse events
Time frame: 30 ± 3 days
Number and proportion of participants experiencing one or more adverse events considered related to 68Ga-PFBH01 administration. Adverse events will be recorded from tracer administration through 30 ± 3 days after PET/CT and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
1 secondary outcome
Maximum standardized uptake value (SUVmax) of 68Ga-PFBH01 in osteosarcoma lesions
Time frame: At the time of PET/CT imaging ("Baseline")
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 Aug 2026.
- Results publication: PubMed 42094601Qiu Y, Gu T, Wang T, Mulati Y, Sun X, Yang Q, Song L, Yuan T, Fan Y, Kang L, Cai W. Integrated radio-theranostics using a [89Zr]Zr-/[177Lu]Lu-labeled B7-H3 antibody-drug conjugate for prostate cancer. Theranostics. 2026 Apr 16;16(11):6132-6144. doi: 10.7150/thno.125878. eCollection 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article will be shared, including relevant clinical characteristics and quantitative PET/CT imaging data. Data that could compromise participant privacy will not be shared.
Related trials for Osteosarcoma
RecruitingPhase 1/2
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
RecruitingObservational study
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
Pheochromocytoma, Paraganglioma
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
RecruitingPhase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
RecruitingPhase 2
Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
Pediatric Osteosarcoma
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 68Ga-B7-H3 Nanobody PET/CT in people with Osteosarcoma and Osteosarcoma, Recurrent, Refractory, run by Peking University First Hospital 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 Aug 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 Tingfei Gu, M.D (010-83572913, tingfei.gu@stx.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion detection rate of 68Ga-B7-H3 nanobody PET/CT (time frame: Baseline (at the time of PET/CT imaging)). The study lists 2 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 NCT07774533, which also lists 1 linked publication.
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 Aug 2026.