Evaluation of a new radioligand therapy for solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Haojun Chen, MD, PhD
• Email: leochen0821@foxmail.com
• Phone: +8618659285282

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining cyclophosphamide, sorafenib, bevacizumab, and atezolizumab for children and young adults with relapsed solid tumors

  This will test whether giving atezolizumab and bevacizumab every three weeks together with daily cyclophosphamide and dose‑adjusted sorafenib is safe and can shrink relapsed or hard‑to‑treat solid tumors in children and young adults, including fibrolamellar carcinoma.

  Recruiting Phase 1/2 St. Jude Children's Research Hospital · Germantown, Tennessee and 1 other locations · NCT05468359

• 68Ga-XHER2 PET/CT imaging to see HER2 in solid tumors

  A noninvasive PET/CT imaging test using 68Ga-XHER2 is being tried to see if it reflects HER2 levels in solid tumors.

  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT07885436

• 68Ga-XMFH01 PET/FL imaging to guide prostate cancer surgery

  This study tests a new dual-modality imaging probe, 68Ga-XMFH01, to preoperatively detect prostate cancer and guide the surgeon with fluorescence during operations in adults with newly diagnosed prostate cancer.

  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT07885423

• Anxiety and Depression in Patients with Hematologic Cancers

  This study tests whether anxiety and depression levels before and after treatment are linked to treatment outcomes in people newly diagnosed with lymphoma, multiple myeloma, or leukemia.

  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT07883070

• VCC combination in relapsed or refractory AML

  A group of adults with relapsed or refractory AML will receive a three-drug combo (venetoclax, chidamide, and chiglitazar sodium) to see if it helps control the leukemia.

  Recruiting Phase 2 The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT07783100

• Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

  This trial tests whether adding orelabrutinib to the Pola-R-CHP regimen can improve outcomes for adults with intermediate- to high-risk newly diagnosed DLBCL.

  Recruiting at 2 sites The First Affiliated Hospital of Xiamen University · Xiamen, Fujian and 1 other locations · NCT07778212

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.