MT218 Injection for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by David Schuster, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Molecular Theranostics LLC

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase 1b open label, dose-escalating investigation study is to evaluate the dose dependent initial efficacy of the use of MT218 injection for biomarker targeted MR molecular imaging (MRMI) of prostate cancer in patients scheduled for radical prostatectomy.

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.

What data supports the effectiveness of the drug MT218 injection for prostate cancer?

Research on similar peptide-drug conjugates shows that they can specifically target prostate cancer cells and improve drug delivery, leading to higher uptake in cancer cells and significant tumor accumulation. This suggests that MT218, which is also a peptide conjugate, might effectively target and treat prostate cancer. ^{1 2 3 4 5}

What makes the MT218 injection drug unique for prostate cancer treatment?

The MT218 injection is unique because it uses a Gd(HP-DO3A) conjugated peptide that targets prostate cancer cells specifically, potentially improving drug delivery and effectiveness compared to traditional treatments. This approach may enhance the concentration of the drug in the tumor while minimizing effects on other tissues. ^{2 3 5 6 7}

Research Team

David Schuster, MD

Principal Investigator

Emory University

Eligibility Criteria

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 am a man older than 18.

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

Trial Timeline

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)

Treatment Details

Interventions

• MT218 injection (Targeted Contrast Agent)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Emory University Atlanta, GA

Who Is Running the Clinical Trial?

Molecular Theranostics LLC

Lead Sponsor

Trials

1

Patients Recruited

10+

Songqi Gao

Lead Sponsor

Trials

1

Patients Recruited

10+

Emory University

Collaborator

Trials

1735

Patients Recruited

2,605,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

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

Development of a peptide-drug conjugate for prostate cancer therapy. [2021]

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

An enzyme-responsive conjugate improves the delivery of a PI3K inhibitor to prostate cancer. [2018]

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

Characterization of a novel prostate-specific antigen-activated peptide-doxorubicin conjugate in patients with prostate cancer. [2016]

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

Combined modality radioimmunotherapy for human prostate cancer xenografts with taxanes and 90yttrium-DOTA-peptide-ChL6. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Anti-GnRH antibodies can induce castrate levels of testosterone in patients with advanced prostate cancer. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

(68)Ga-PSMA-11 dynamic PET/CT imaging in biochemical relapse of prostate cancer. [2021]