MedDataX Logo

177Lu-AB-3PRGD2 in Patients With Integrin αVβ3 Positive Tumors

NCT ID: NCT05013086

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is an open-label, non-controlled, non-randomized study to assess the safety and measure image-based absorbed dose of 177Lu-AB-3PRGD2 in patients with Integrin αVβ3 positive tumors who will undergo radioliagnd therapy using 177Lu-AB-3PRGD2.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Integrin αvβ3 is highly expressed in some tumor cells and neovascularization, which is an ideal target for diagnosis and treatment of Integrin αVβ3 positive tumors. 177Lu-AB-3PRGD2, is a kind of new drug based on independent research and development in China, provide an effective target for the treatment of Integrin αVβ3 positive tumors. All patients underwent whole-body 68Ga-RGD PET/CT for selection and accepted intravenous injection with single dose 1.48 GBq (40 mCi) of 177Lu-AB-3PRGD2 within one week. 1-2 ml venous blood was collected at 5min, 3h, 24h, 72h and 168h after administration to detect radioactivity count, respectively. Then monitored at 3, 24, 48, 72, 96, 120 and 168 h after 177Lu-AB-3PRGD2 administration with serial whole body planar and SPECT/CT imaging (72 or 96h). Analyze and calculate the internal radiation dose of 177Lu-AB-3PRGD2 and evaluate its therapeutic efficiency and response.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Integrin αVβ3 Positive Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1.48 GBq of 177Lu-AB-3PRGD2

The patients were intravenously injected with the dose about 1.48GBq (40 mCi) of 177Lu-AB-3PRGD2 and underwent 68Ga-RGD PET/CT scans before and after the treatment.

Group Type EXPERIMENTAL

1.48 GBq of 177Lu-AB-3PRGD2

Intervention Type DRUG

accepted intravenous injection of 177Lu-AB-3PRGD2

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

1.48 GBq of 177Lu-AB-3PRGD2

accepted intravenous injection of 177Lu-AB-3PRGD2

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with clear pathological diagnosis and ineffective or progressing clinical conventional treatment;
* tumor lesions with high RGD untake confirmed on 68Ga-RGD PET/CT within one week before the injection of 177Lu-AB-3PRGD2;
* signed written consent.

Exclusion Criteria

* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhaohui Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhaohui Zhu, MD

Role: CONTACT

Phone: 86-13611093752

Email: [email protected]

Guochang Wang, MD

Role: CONTACT

Phone: 86-18516822732

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhaohui Zhu, MD

Role: primary

Guochang Wang, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PekingUMCH AB-3PRGD2

Identifier Type: -

Identifier Source: org_study_id