Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression

NCT06375564 | Recruiting Phase 1

• 1 other identifier: XMYY-2020KY067-05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractory Solid Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of Cycle 4 (each cycle is 42 days)

Secondary Outcomes (1)

• Incidence of treatment-related adverse events (safety and tolerability)

  At the end of Cycle 4 (each cycle is 42 days)

Study Arms (1)

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

Drug: 177Lu-AB-3PRGD2 radioligand therapy

Interventions

177Lu-AB-3PRGD2 radioligand therapy DRUG

Radioligand therapy using 177Lu-AB-3PRGD2 80 mCi (2.96 GBq) will be performed 6-weekly. A maximum of 4 cycles will be administered.

177Lu-AB-3PRGD2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Study Officials

• Haojun Chen, MD, PhD

  The First Affiliated Hospital of Xiamen University

  STUDY CHAIR

Central Study Contacts

Haojun Chen, MD, PhD

CONTACT

+8618659285282; leochen0821@foxmail.com

Hao Fu

CONTACT

+8615959230059; fuhaonuclear@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 19, 2024
• Study Start: June 12, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)