Refractory Solid TumorPhase 1NCT06375564
Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression
A Phase 1 study testing 177Lu-AB-3PRGD2 radioligand therapy in people with Refractory Solid Tumor, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
This is an open-label, non-controlled, non-randomized study to assess the therapeutic efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors who will undergo radioligand therapy using 177Lu-AB-3PRGD. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Refractory Solid Tumor
- What is being tested?
- 177Lu-AB-3PRGD2 radioligand therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2024to 30 Dec 2026
- Phase
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to sign a written informed consent document.
- Age 18 and older.
- Confirmed unresectable or metastatic refractory cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis).
- Progressive disease after multiple-lines treatment.
- Eastern Cooperative Oncology Group Performance Status ≤ 3.
- Participant must have completed prior therapy at least 2 weeks (washout period) before 68Ga-RGD PET/CT scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved below Grade 2 or baseline. Completion of entry into 68Ga-RGD study and completion of the scan.
- Hematologic parameters are defined as Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 50,000/mm3 Hemoglobin ≥ 8 g/dL.
- Blood chemistry levels defined as AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 3 times ULN Creatinine ≤ 3 times ULN Able to remain motionless for up to 30-60 minutes per scan.
Who cannot join
- Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA).
- Participants with Class 3 or 4 NYHA Congestive Heart Failure.
- Clinically significant bleeding within two weeks before trial entry (e.g. gastrointestinal bleeding, intracranial bleeding).
- Pregnant or lactating women.
- Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days before study day 1 or anticipated surgery within the subsequent 6 weeks.
- Has an additional active malignancy requiring therapy within the past 2 years.
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- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Psychiatric illness/social situations that would interfere with compliance with study requirements
- Cannot undergo PET/CT scanning because of weight limits (350 lbs).
- INR>1.2; PTT>5 seconds above UNL.
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
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Haojun Chen, +8618659285282, leochen0821@foxmail.com
Hao Fu, MD, PhD, +8615959230059, fuhaonuclear@163.com
About this study
Official title: An Open-Label, Non-Randomized, Single-Center, Investigator-Initiated Trial to Determine the Effectiveness of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression
This is an open-label, non-controlled, non-randomized study to assess the therapeutic efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors who will undergo radioligand therapy using 177Lu-AB-3PRGD.
Read the detailed description
Integrin αvβ3 is highly expressed in some tumor cells and neovascularization, which is an ideal target for diagnosis and treatment of solid tumors. 177Lu-AB-3PRGD2, is a kind of new drug based on independent research and development in China, providing an effective target for the treatment of tumors. All patients underwent whole-body 68Ga-RGD PET/CT for selection and accepted intravenous injection with a fixed dose of 2.96 GBq (80 mCi) of 177Lu-AB-3PRGD2 within one week. Treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the preliminary treatment efficacy of 177Lu-AB-3PRGD2 used for radioligand therapy in patients with various advanced tumors. The secondary endpoint evaluates the safety of 177Lu-AB-3PRGD2.
- Conditions
- Refractory Solid Tumor
- Being tested
- 177Lu-AB-3PRGD2 radioligand therapy
- Keywords
- Refractory Solid Tumor, Radioligand therapy, 177Lu-AB-3PRGD2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-AB-3PRGD2 radioligand therapyDrug
Radioligand therapy using 177Lu-AB-3PRGD2 80 mCi (2.96 GBq) will be performed 6-weekly. A maximum of 4 cycles will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-AB-3PRGD2 | Experimental | 177Lu-AB-3PRGD2 A maximum of 4 cycles of 80 mCi (2.96 GBq) 177Lu-AB-3PRGD2, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, every 6 weeks Receives: Drug: 177Lu-AB-3PRGD2 radioligand therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
68Ga-RGD will be performed for efficacy evaluation by RECIST 1.1. Particularly, 68Ga-RGD will be performed at baseline, and 6 weeks after two treatment cycles.
Measured: At the end of Cycle 4 (each cycle is 42 days)
Secondary outcomes (1)
Incidence of treatment-related adverse events (safety and tolerability)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Dose-limiting toxicity was defined as any 177Lu-AB-3PRGD2-related AE ≥ grade 3 (G3). For Hemoglobin < 8.0 g/dL; < 4.9 mmol/L; < 80 g/L; Need blood transfusion heal. Severe hypocytosis or with this age group The total number of normal cells was reduced >50% and ≤75%.
Measured: At the end of Cycle 4 (each cycle is 42 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start12 Jun 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Solid TumorStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haojun Chen, MD, PhD, Study chair, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375564
- Sponsor's protocol ID
- XMYY-2020KY067-05
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized, Single-Center, Investigator-Initiated Trial to Determine the Effectiveness of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression
- ClinicalTrials.gov ID
- NCT06375564
- Acronym / sponsor ID
- XMYY-2020KY067-05
- Conditions
- Refractory Solid Tumor
- Keywords
- Refractory Solid Tumor, Radioligand therapy, 177Lu-AB-3PRGD2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Apr 2024 (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 is an open-label, non-controlled, non-randomized study to assess the therapeutic efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors who will undergo radioligand therapy using 177Lu-AB-3PRGD.
Detailed description
Integrin αvβ3 is highly expressed in some tumor cells and neovascularization, which is an ideal target for diagnosis and treatment of solid tumors. 177Lu-AB-3PRGD2, is a kind of new drug based on independent research and development in China, providing an effective target for the treatment of tumors. All patients underwent whole-body 68Ga-RGD PET/CT for selection and accepted intravenous injection with a fixed dose of 2.96 GBq (80 mCi) of 177Lu-AB-3PRGD2 within one week. Treatment is planned for up to 4 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the preliminary treatment efficacy of 177Lu-AB-3PRGD2 used for radioligand therapy in patients with various advanced tumors. The secondary endpoint evaluates the safety of 177Lu-AB-3PRGD2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 177Lu-AB-3PRGD2 | Experimental | Drug: 177Lu-AB-3PRGD2 radioligand therapy177Lu-AB-3PRGD2 A maximum of 4 cycles of 80 mCi (2.96 GBq) 177Lu-AB-3PRGD2, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, every 6 weeks |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to understand and willingness to sign a written informed consent document.
- Age 18 and older.
- Confirmed unresectable or metastatic refractory cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis).
- Progressive disease after multiple-lines treatment.
- Eastern Cooperative Oncology Group Performance Status ≤ 3.
Key exclusion criteria (10 listed)
- Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA).
- Participants with Class 3 or 4 NYHA Congestive Heart Failure.
- Clinically significant bleeding within two weeks before trial entry (e.g. gastrointestinal bleeding, intracranial bleeding).
- Pregnant or lactating women.
- Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days before study day 1 or anticipated surgery within the subsequent 6 weeks.
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-AB-3PRGD2 radioligand therapyRadioligand therapy using 177Lu-AB-3PRGD2 80 mCi (2.96 GBq) will be performed 6-weekly. A maximum of 4 cycles will be administered. | Drug | 177Lu-AB-3PRGD2 |
Primary outcome
Objective response rate (ORR)
Time frame: At the end of Cycle 4 (each cycle is 42 days)
68Ga-RGD will be performed for efficacy evaluation by RECIST 1.1. Particularly, 68Ga-RGD will be performed at baseline, and 6 weeks after two treatment cycles.
1 secondary outcome
Incidence of treatment-related adverse events (safety and tolerability)
Time frame: At the end of Cycle 4 (each cycle is 42 days)
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 8 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Haojun Chen, MD, PhD study chair
The First Affiliated Hospital of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 177Lu-AB-3PRGD2 radioligand therapy in people with Refractory Solid Tumor, run by The First Affiliated Hospital of Xiamen University 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 8 inclusion and 10 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 8 Aug 2025. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Haojun Chen, MD, PhD (+8618659285282, leochen0821@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: At the end of Cycle 4 (each cycle is 42 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2025.