PET Imaging with 124I-PUH71 for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Iodide products

Disqualifiers: Hyperthyroidism, Allergic reaction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, PUH71, to determine its distribution in the body and duration in the blood. The goal is to assess whether PUH71 can treat cancer or aid in tumor detection through scanning. Participants receive a small dose of the drug and undergo multiple PET scans over several days. This trial may suit individuals with solid tumors, blood cancers like lymphoma, or certain rare blood disorders, provided they do not have thyroid issues or iodine allergies. As a Phase 1 trial, the research focuses on understanding how PUH71 works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that PUH71 is safe for use in PET imaging?

Research has shown that 124I-PUH71 has been tested in people before. One study found that using 124I-PUH71 for PET scans in cancer patients was safe and effective, with patients experiencing no serious side effects. Another study discovered that the tracer, part of the treatment, sometimes unexpectedly accumulated in the heart muscle. However, this did not harm the patients. These findings suggest that 124I-PUH71 is generally safe when used in small amounts for imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of 124I-PUH71 for cancer because it offers a novel approach to imaging tumors. Unlike traditional imaging techniques, which often rely on general radiotracers, 124I-PUH71 specifically targets the heat shock protein Hsp90, a protein commonly overexpressed in cancer cells. This targeted approach could potentially improve the accuracy of tumor detection and monitoring by highlighting cancer cells more clearly, making it easier to assess how well treatments are working. Additionally, through PET imaging, it allows for a non-invasive method to track the progression of the disease in real time.

What evidence suggests that PUH71 might be an effective treatment for cancer?

Research has shown that PUH71 targets a part of cancer cells called the epichaperome. In this trial, participants will receive 124I-PUH71, which helps make tumors visible by causing them to light up on PET scans. This effect has been observed in various solid tumors and lymphomas, a type of blood cancer. Early studies indicate that PUH71 effectively locates these cancer-related areas in the body, making it a promising tool for understanding tumor location and behavior. ^{2 4 6 7 8}

Who Is on the Research Team?

Mark Dunphy, DO

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 with certain types of cancer, including solid tumors, myeloma, and lymphomas that can be measured or evaluated. Women must not be pregnant or breastfeeding. Participants should not have had allergic reactions to contrast media, iodide hypersensitivity, hyperthyroidism, significant kidney or liver issues, or acute major illnesses.

Inclusion Criteria

My cancer type has been confirmed by pathology.

I am not pregnant or unable to become pregnant.

No breast-feeding

Exclusion Criteria

I have been diagnosed with an overactive thyroid.

My liver function tests are within the trial's required ranges.

My kidney function is reduced, with creatinine levels high or clearance low.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an injection of 124I-PUH71 followed by serial PET scanning and blood draws over 3 days, with an optional fourth day of PET scanning

1 week

3-4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PUH71

Trial Overview

Researchers are testing a new drug called PUH71 using PET imaging to see how it distributes in the body and tumors and its duration in the blood. This will inform future high-dose trials for cancer treatment and potential use in tumor detection.

How Is the Trial Designed?

Group I: PET Imaging Using 124 IPUH71 Experimental Treatment 1 Intervention

Patients will receive an injection of up to 11.0 mCi (range: 4.0-11.0 mCi) of 124I-PUH71, followed by serial PET scanning and blood draws, over a period of 3 days. Optional with a fourth day of PET scanning is to be pursued, in willing patients.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Samus Therapeutics

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

The new α-particle-emitting compound 225Ac-L1 shows specific targeting and effective cell kill in prostate cancer cells that express PSMA, demonstrating significant tumor growth inhibition and improved survival in xenograft models.

While 225Ac-L1 has promising efficacy, it also presents some off-target radiotoxicity, particularly in the kidneys and liver, with a maximum tolerated dose estimated at about 1 MBq/kg, indicating a need for careful dosing in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Evaluation of 213Bi- and 225Ac-Labeled Low-Molecular-Weight Compounds for Radiopharmaceutical Therapy of Prostate Cancer. Banerjee, SR., Lisok, A., Minn, I., et al.[2022]

The study of 124I-labeled toripalimab (124I-JS001) in 11 patients with melanoma and urologic cancer showed it to be a safe PET imaging tracer with no adverse events and acceptable dosimetry of 0.236 mSv/MBq.

124I-JS001 demonstrated favorable biodistribution, with high uptake in the spleen and liver, and significantly improved tumor detection when combined with unlabeled JS001, indicating its potential as a tool for identifying patients who may benefit from PD-1 therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron Emission Tomography Imaging of Programmed Death 1 Expression in Cancer Patients Using 124I-Labeled Toripalimab: A Pilot Clinical Translation Study. Wang, S., Zhu, H., Ding, J., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7713524/

Measuring Tumor Epichaperome Expression Using [124I] ...

In this phase Ib trial, we present safety and tolerability for PU-H71 plus nab-paclitaxel in HER2-negative patients with metastatic breast cancer (MBC)

2.

ascopubs.org

ascopubs.org/doi/10.1200/jco.2013.31.15_suppl.11076

Using 124I-PU-H71 PET imaging to predict intratumoral ...

PU-H71 can be used to visualize PU-H71 uptake in a variety of solid tumors and lymphoma, and PU-H71 PET scans can be used to estimate intratumoral ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7541604/

First-in-Human Trial of Epichaperome-Targeted Positron ...

Our clinical PET data indicates the presence of tumor epichaperome formations in a variety of cancer types, as previously demonstrated preclinically (1). PU-H71 ...

4.

withpower.com

withpower.com/trial/early-phase-1-lymphoma-non-hodgkin-11-2010-43ac6

PET Imaging with 124I-PUH71 for Cancer

The study on 124I-PU-H71 shows that it is a promising tool for imaging tumors by targeting epichaperome formations, which are linked to cancer. This suggests ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01393509?term=PUH-71&rank=2

The First-in-human Phase I Trial of PU-H71 in Patients With ...

The purpose of this study is to test a new drug, called PU-H71 for the first time in humans, to find out what effects, good or bad, this new drug has on the ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39935517/

Epichaperome-targeted myocardial imaging by 124I-PU-H71 ...

Our study finds human myocardial epichaperome expression, as quantified by 124 I-PU-H71 PET. Our data indicates PU-H71 PET merits further study as a ...

7.

link.springer.com

link.springer.com/article/10.1007/s40336-024-00658-9

Epichaperome-targeted myocardial imaging by 124I-PU ...

A first-in-human imaging trial using positron emission tomography (PET) in cancer patients revealed unexpected tracer accumulation in the myocardium.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S1355814524000774

An update on the status of HSP90 inhibitors in cancer ...

In 2020, first-in-human trial results of PET imaging of cancer patients using 124I-PUH71 were published. The data demonstrated the safety and feasibility of ...