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

63 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to see how a new drug, named PUH71, accumulates in the different parts of the body \& inside tumors and how long PUH71 lasts in the blood, when given to study participants in tiny amounts. The results of this study will help researchers (1) plan how they will use PUH71 as an experimental new drug (at much-higher doses) for the treatment of cancer, in clinical trials; and (2) know whether PUH71 might be used as a drug for detecting tumors with scanner machines.

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.

Is 124I-PUH71 safe for use in humans?

In a first-in-human study, 124I-PU-H71 was evaluated for safety, and no significant safety concerns were reported, indicating it is generally safe for use in humans. ^{1 2 3 4 5}

How does the drug 124I-PUH71 differ from other cancer treatments?

124I-PUH71 is unique because it targets epichaperome formations in tumors, which are structures that form under cellular stress and are a validated target for cancer therapy. This drug is used in PET imaging to visualize these formations, providing a novel approach to cancer diagnosis and treatment monitoring that differs from traditional therapies. ^{1 4 6 7 8}

What data supports the effectiveness of the drug PUH71 for cancer treatment?

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 that PUH71 could be effective in identifying and potentially treating cancer by focusing on these specific tumor structures. ^{1 4 9 10 11}

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 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]

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]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Development of Radiotracers for Imaging of the PD-1/PD-L1 Axis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Repeatability of [68Ga]DKFZ11-PSMA PET Scans for Detecting Prostate-specific Membrane Antigen-positive Prostate Cancer. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

First-in-Human Trial of Epichaperome-Targeted PET in Patients with Cancer. [2021]

4. United States 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. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Biodistribution and dosimetry for combined [177Lu]Lu-PSMA-I&amp;T/[225Ac]Ac-PSMA-I&amp;T therapy using multi-isotope quantitative SPECT imaging. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Preclinical Evaluation of 213Bi- and 225Ac-Labeled Low-Molecular-Weight Compounds for Radiopharmaceutical Therapy of Prostate Cancer. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Preclinical Evaluation of a Companion Diagnostic Radiopharmaceutical, [18F]PSMA-1007, in a Subcutaneous Prostate Cancer Xenograft Mouse Model. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Improving Theranostic Gallium-68/Lutetium-177-Labeled PSMA Inhibitors with an Albumin Binder for Prostate Cancer. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Quantitative imaging of I-124 using positron emission tomography with applications to radioimmunodiagnosis and radioimmunotherapy. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Production of iodine-124 and its applications in nuclear medicine. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Molecular imaging with copper-64. [2013]