MT218 Injection for Prostate Cancer

Overseen By David M Schuster, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Molecular Theranostics LLC

Disqualifiers: Kidney disease, Liver disease, Diabetes, Hypertension, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of the MT218 injection (a Gd(HP-DO3A) conjugated peptide) in enhancing MRI scans to identify prostate cancer in patients scheduled for prostate removal. The study aims to determine the optimal dose of MT218 for these scans. Men with a confirmed Gleason score between 8 and 10 for prostate cancer, who have undergone an MRI and a biopsy, and can remain still for an MRI, might be suitable candidates. This trial could enhance how doctors visualize prostate cancer, potentially leading to better treatment decisions. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's function in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in prostate cancer imaging.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking any MRI contrast agents, you must not have received them within 48 hours before or 24 hours after the MT218 injection.

Is there any evidence suggesting that MT218 injection is likely to be safe for humans?

Research has shown that MT218, a special agent used in MRI scans, is well-tolerated by healthy men. Studies have found that MT218 appears safe, as participants did not report any major side effects. This suggests MT218 is generally safe for people.

In early tests, MT218 demonstrated strong properties important for its effectiveness and safety. It also showed higher uptake in prostate cancer cells, potentially improving imaging of these cells.

Since this trial is in its early stages, it focuses on testing safety and determining the right dose. While some uncertainty remains about the treatment, the results so far are encouraging regarding safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for prostate cancer involve hormone therapy, surgery, radiation, or chemotherapy. But MT218 is different because it is delivered as a single intravenous injection while using advanced MR imaging to monitor its effects. Researchers are excited about MT218 because it introduces a new approach by varying doses to determine optimal levels for effectiveness, potentially improving precision in treatment. The use of MRI during administration could also provide real-time insights into how the treatment interacts with cancer cells, offering a more tailored therapy option. This method sets MT218 apart from current standards that often require longer courses of treatment and less precise monitoring.

What evidence suggests that MT218 injection might be an effective treatment for prostate cancer?

Research shows that the MT218 injection, which trial participants will receive, holds promise for detecting aggressive prostate cancer. Studies indicate that MT218 enhances MRI images more effectively than standard methods, aiding in the identification of aggressive tumors. The drug binds well to prostate cancer cells, making them more visible in scans. Additionally, MT218 distinguishes between aggressive and less severe prostate cancers. These features suggest that MT218 could significantly improve the identification and treatment of prostate cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

David Schuster, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer who are scheduled to have their prostate removed. It's an early-phase study, so they're looking for people who haven't had this kind of imaging before.

Inclusion Criteria

Patients must be able to provide written informed consent

My kidney function is good, with a GFR over 60 mL/min.

I can stay still for an MRI scan.

Exclusion Criteria

Patients with uni- or bilateral hip prosthesis

Patients with contraindications for MRI including implantable pace makers, cochlear implants

Is determined by the investigator that the patient is clinically unsuitable for the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous injection of MT218 and undergo MR imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 3 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MT218 injection

Trial Overview

The study tests different doses of a new MRI contrast agent called MT218 to see how well it shows prostate cancer on scans. This is done just before patients have surgery to remove the prostate.

How Is the Trial Designed?

Group I: MT218 Experimental Treatment 1 Intervention

Each patient will receive a single intravenous injection of MT218 while being scanned with standard MR imaging sequences/protocol. The first cohort of four subjects will receive 0.02 mmol/kg, second cohort of four subjects will receive 0.04 mmol/kg, and third cohort of four subjects will receive 0.06 mmol/kg of MT218.

Who Is Running the Clinical Trial?

Molecular Theranostics LLC

Lead Sponsor

Trials

1

Recruited

10+

Songqi Gao

Lead Sponsor

Trials

1

Recruited

10+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

In a study using nude mice with human prostate cancer, combining the radiation therapy 90Y-DOTA-peptide-ChL6 with docetaxel resulted in a 67% cure rate, while the combination with paclitaxel achieved a 100% response rate with 20% cures, indicating significant therapeutic synergy.

The addition of these chemotherapy drugs did not increase toxicity compared to radiation therapy alone, suggesting that this combined treatment approach could be safely translated to clinical settings for improved prostate cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined modality radioimmunotherapy for human prostate cancer xenografts with taxanes and 90yttrium-DOTA-peptide-ChL6. O'Donnell, RT., DeNardo, SJ., Miers, LA., et al.[2019]

In a study of 31 men with recurrent prostate cancer, (68)Ga-PSMA-11 PET/CT showed a detection rate of 71%, indicating its efficacy in identifying cancer recurrence, especially in patients with higher PSA levels.

The study found a moderate correlation between PSA levels and both the number of lesions detected and the uptake of the radiotracer in cancerous lesions, suggesting that (68)Ga-PSMA-11 can be a useful tool for monitoring disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(68)Ga-PSMA-11 dynamic PET/CT imaging in biochemical relapse of prostate cancer. Sachpekidis, C., Eder, M., Kopka, K., et al.[2021]

In a study involving 26 prostate cancer patients (14 with biochemically recurrent and 12 with metastatic hormone-refractory cancer), personalized peptide vaccination successfully enriched T cells reactive to multiple tumor-associated antigens (TAAs) after a 2-week culture period.

The approach demonstrated that priming lymphocytes with TAAs-derived peptides led to the development of polyclonal effector CD8+ T cells, indicating its potential as a viable strategy for T cell immunotherapy in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized ex vivo multiple peptide enrichment and detection of T cells reactive to multiple tumor-associated antigens in prostate cancer patients. Taborska, P., Stakheev, D., Strizova, Z., et al.[2021]

The enzyme-responsive peptide drug conjugate developed for TGX-D1, a PI3K inhibitor, shows improved cellular uptake in prostate cancer cells by about nine times, enhancing its potential efficacy in treatment.

This conjugate is designed to remain stable in the bloodstream of prostate cancer patients but can be cleaved by high levels of prostate-specific antigen (PSA) in the tumor microenvironment, allowing for targeted delivery and significant accumulation in tumors while minimizing distribution to other tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An enzyme-responsive conjugate improves the delivery of a PI3K inhibitor to prostate cancer. Barve, A., Jain, A., Liu, H., et al.[2018]

L-377202, a novel peptide conjugate of doxorubicin, was well tolerated in 19 patients with advanced hormone-refractory prostate cancer, with a recommended dose of 225 mg/m² established for further efficacy studies.

The drug was successfully metabolized into active forms, leucine-doxorubicin and doxorubicin, and showed promising results with some patients experiencing significant decreases in PSA levels, indicating potential effectiveness in treating prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of a novel prostate-specific antigen-activated peptide-doxorubicin conjugate in patients with prostate cancer. DiPaola, RS., Rinehart, J., Nemunaitis, J., et al.[2016]

The pilot study involving 12 patients with locally advanced prostate cancer demonstrated that the immunotherapy D17DT was well tolerated and led to significant reductions in serum testosterone and PSA levels in some patients.

Four patients achieved castrate levels of testosterone that were maintained for up to 9 months, suggesting that immunizing against GnRH could be an effective alternative to traditional hormonal therapies, especially in those with higher anti-GnRH antibody titres.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-GnRH antibodies can induce castrate levels of testosterone in patients with advanced prostate cancer. Simms, MS., Scholfield, DP., Jacobs, E., et al.[2018]

TGX-221, a potent PI3Kβ inhibitor, has been modified into a peptide-drug conjugate that specifically targets HER2 overexpressing prostate cancer cells, enhancing its delivery and effectiveness.

The peptide-drug conjugate showed significantly higher cellular uptake in prostate cancer cells compared to the original drug, and both the conjugate and its cleaved products maintained similar activity to TGX-D1, indicating its potential as an effective chemotherapy option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a peptide-drug conjugate for prostate cancer therapy. Tai, W., Shukla, RS., Qin, B., et al.[2021]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9444296/

Evaluation of Physicochemical Properties, Pharmacokinetics ...

MT218 produces robust specific magnetic resonance (MR) contrast enhancement at doses lower than those of the base GBCA in several types of aggressive tumors, ...

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withpower.com

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MT218 Injection for Prostate Cancer

The peptide-drug conjugate showed significantly higher cellular uptake in prostate cancer cells compared to the original drug, and both the conjugate and its ...

3.

pubs.acs.org

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MR Molecular Imaging of Extradomain-B Fibronectin for ...

MT218 is able to produce robust contrast enhancement in aggressive tumors and differentiate aggressive prostate cancer from low grade tumors in ...

4.

researchgate.net

researchgate.net/publication/325623992_Optimization_of_ZD2_Peptide_Targeted_GdHP-DO3A_for_Detection_and_Risk-Stratification_of_Prostate_Cancer_with_MRI

Optimization of ZD2 Peptide Targeted Gd(HP-DO3A) for ...

MT218 has a higher T 1 relaxivity than Gd(HP-DO3A) and has demonstrated superior contrast enhancement in aggressive breast and prostate cancers (15,16,(20)(21)( ...

5.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/461396

Evaluation of a Targeted Magnetic Resonance Imaging ...

Primary outcome measures. Detection of aggressive prostate cancer (Gleason score 8 to 10) using peptide based MRI contrast agent (MT218) with ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10987082/

Pharmacokinetics and tolerability of the cancer-targeting MRI ...

The aim of this study was to evaluate the pharmacokinetics and safety profile of MT218, a peptide-targeted gadolinium-based contrast agent, in healthy males.

7.

researchgate.net

researchgate.net/publication/376007518_Pharmacokinetics_and_Tolerability_of_the_Cancer-Targeting_MRI_Contrast_Agent_MT218_in_Healthy_Males

Pharmacokinetics and Tolerability of the Cancer-Targeting ...

Objective The aim of this study was to evaluate the pharmacokinetics and safety profile of MT218, a peptide-targeted gadolinium-based ...