Evaluation of a new radioligand therapy for solid tumors

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 study is testing a new type of treatment for people with solid tumors that show a specific marker to see if it helps shrink the tumors and is safe to use.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Xiamen University (Academic / other)
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT06375564 on ClinicalTrials.gov

What this trial studies

This open-label, non-controlled, non-randomized clinical evaluation assesses the efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors that express integrin αvβ3. Patients will undergo whole-body 68Ga-RGD PET/CT for selection and receive intravenous injections of 177Lu-AB-3PRGD2, with treatment planned for up to four cycles at six-week intervals. The primary endpoint focuses on the preliminary treatment efficacy, while the secondary endpoint evaluates the safety of the therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable or metastatic refractory cancer that has shown progression after multiple lines of treatment.

Not a fit: Patients with resectable tumors or those who have not progressed after standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with refractory solid tumors.

How similar studies have performed: While this approach is novel, similar studies targeting integrin αvβ3 have shown promise in treating solid tumors.

Eligibility criteria

Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document.
2. Age 18 and older.
3. 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).
4. Progressive disease after multiple-lines treatment.
5. Eastern Cooperative Oncology Group Performance Status ≤ 3.
6. 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.
7. Hematologic parameters are defined as Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 50,000/mm3 Hemoglobin ≥ 8 g/dL.
8. 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.

Exclusion Criteria:

1. Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA).
2. Participants with Class 3 or 4 NYHA Congestive Heart Failure.
3. Clinically significant bleeding within two weeks before trial entry (e.g. gastrointestinal bleeding, intracranial bleeding).
4. Pregnant or lactating women.
5. 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.
6. Has an additional active malignancy requiring therapy within the past 2 years.
7. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
8. Psychiatric illness/social situations that would interfere with compliance with study requirements
9. Cannot undergo PET/CT scanning because of weight limits (350 lbs).
10. INR\>1.2; PTT\>5 seconds above UNL.

Where this trial is running

Xiamen, Fujian

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Haojun Chen, MD, PhD

Conditions Refractory Solid Tumor; Radioligand therapy; 177Lu-AB-3PRGD2