NCT06636617

Brief Summary

This is a pilot study to assess the dosimetry, toxicity and response of 177Lu-JH04, a new FAP-targeted radiopharmaceutical, in patients with FAP-Positive Tumors. All patients underwent 68Ga-FAPI PET/CT for selection and were successively divided into three groups of 3 people each.The three groups received successively an approximately 3.70 GBq (100 mCi), 5.55 GBq (150 mCi) and 7.40 GBq (200 mCi) of 177Lu-JH04 up to 4 cycles.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Aug 2024

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 22, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

October 10, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 22, 2024

Last Update Submit

October 9, 2024

Conditions

Patients with Advanced Metastatic FAP-Positive Tumors

Keywords

Lu-177FAPTumor

Outcome Measures

Primary Outcomes (1)

  • Toxic and side effect

    The white blood cell count, granulocyte count, platelet count, hemoglobin count and serum biochemicals of each patient before and after each treatment were recorded and compared. And the weight (in kilograms) of the patients was monitored. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.

    through study completion, an average of 2 weeks

Secondary Outcomes (1)

  • Dosimetry of normal organs and tumors

    through study completion, an average of 4 weeks

Other Outcomes (1)

  • Treatment Response

    through study completion, an average of 3 months

Study Arms (3)

3.70 GBq (100 mCi) of 177Lu-JH04

EXPERIMENTAL

All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04.

Drug: 3.70 GBq (100 mCi) of 177Lu-JH04

5.55 GBq (150 mCi) of 177Lu-JH04

EXPERIMENTAL

All 3 patients were intravenous injected with single dose 5.55 GBq (150 mCi) of 177Lu-JH04.

Drug: 5.55 GBq (150 mCi) of 177Lu-JH04

7.40 GBq (200 mCi) of 177Lu-JH04

EXPERIMENTAL

All 3 patients were intravenous injected with single dose 7.40 GBq (200 mCi) of 177Lu-JH04.

Drug: 7.40 GBq (200 mCi) of 177Lu-JH04

Interventions

3.70 GBq (100 mCi) of 177Lu-JH04DRUG

All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04.

3.70 GBq (100 mCi) of 177Lu-JH04
5.55 GBq (150 mCi) of 177Lu-JH04DRUG

All 3 patients were intravenous injected with single 5.55 GBq (150 mCi) of 177Lu-JH04

5.55 GBq (150 mCi) of 177Lu-JH04
7.40 GBq (200 mCi) of 177Lu-JH04DRUG

All 3 patients were intravenous injected with single 7.40 GBq (200 mCi) of 177Lu-JH04

7.40 GBq (200 mCi) of 177Lu-JH04

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • progressive advanced metastatic tumors
  • tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT
  • adequate renal, haematological, and liver function
  • an Eastern Cooperative Oncology Group performance status of 0-2

You may not qualify if:

  • pregnant or lactating women
  • received other radionuclide therapy in the past 6 months
  • received chemotherapy, radiotherapy and other anti-tumor treatments in the past 28 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Weibing Miao, MD

    The First Affiliated Hospital, Fujian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weibing Miao, MD

CONTACT

+86-0591-87981618miaoweibing@126.com

Guochang Wang, MD

CONTACT

+86-0591-87981619guochang1007@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2024

First Posted

October 10, 2024

Study Start

August 21, 2024

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

October 10, 2024

Record last verified: 2024-09

Locations

CN(1)