177Lu-JH04 in Patients with FAP-Positive Tumors

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

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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Cancer-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment and present abundantly in the stroma of multiple tumor entities. Fibroblast activation protein (FAP), as a specific marker protein of CAFs, is overexpressed on more than 90% of malignant tumors\& limited and expression in normal tissues, making it an appropriate target for diagnosis and therapy of numerous malignant tumors. Currently, several radiopharmaceuticals targeting FAP for radionuclide therapy have been developed, such as 177Lu-FAPI-46, 177Lu-FAP-2286, and showed high efficacy and reasonable toxicity profile in tumor treatment. 177Lu-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, we assess the dosimetry, toxicity and response of 177Lu-JH04 for the treatment of patients with advanced metastatic cancers after exhaustion of all other treatment options.

Conditions

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Patients with Advanced Metastatic FAP-Positive Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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3.70 GBq (100 mCi) of 177Lu-JH04

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

Group Type EXPERIMENTAL

3.70 GBq (100 mCi) of 177Lu-JH04

Intervention Type DRUG

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

5.55 GBq (150 mCi) of 177Lu-JH04

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

Group Type EXPERIMENTAL

5.55 GBq (150 mCi) of 177Lu-JH04

Intervention Type DRUG

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

7.40 GBq (200 mCi) of 177Lu-JH04

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

Group Type EXPERIMENTAL

7.40 GBq (200 mCi) of 177Lu-JH04

Intervention Type DRUG

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

Interventions

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3.70 GBq (100 mCi) of 177Lu-JH04

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

Intervention Type DRUG

5.55 GBq (150 mCi) of 177Lu-JH04

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

Intervention Type DRUG

7.40 GBq (200 mCi) of 177Lu-JH04

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No