PSMA-Targeted Trillium Compounds + PTI-122 for Prostate Cancer

No longer recruiting at 4 trial locations

Overseen By Gretchen Richards, MS

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Ratio Therapeutics, Inc.

Must be taking: Hormone therapy

Must not be taking: PSMA-targeted therapy

Disqualifiers: Other malignancy, Significant illness, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for adult males with metastatic prostate cancer. Researchers aim to understand how different PSMA-targeted compounds, a type of imaging agent, move and behave in the body, both alone and with a protective agent called PTI-122. The study includes several treatment arms: the PSMA compound alone, the compound with a single dose of PTI-122, and the compound with multiple doses of PTI-122. Men with stable prostate cancer treatments and a recent PSMA PET scan showing specific cancer activity might be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not be on any PSMA-targeted therapy and should not be participating in another active treatment trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In earlier studies, PSMA-Targeted \[In-111\]-Labeled Trillium Compounds targeted cancer cells in men with advanced prostate cancer. These compounds carry a radioactive substance to track their movement in the body. Research has shown that these compounds are generally well-tolerated, though detailed information on side effects remains limited.

Specific safety information for combining these Trillium Compounds with the protective agent PTI-122 is not yet available. The study is in its early stages, and researchers are still gathering basic safety data. While initial results may be promising, confirming safety is still in the early phase.

Participants should consult the study team and their healthcare providers to understand the potential risks and benefits before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PSMA-Targeted Trillium Compounds with PTI-122 because they offer a new way to target prostate cancer cells. Unlike traditional treatments like chemotherapy and hormone therapy, which affect both cancerous and healthy cells, this treatment specifically targets the Prostate-Specific Membrane Antigen (PSMA) found on prostate cancer cells, potentially leading to fewer side effects. The use of [In-111]-Labeled Trillium Compound allows for precise tracking of the treatment in the body, offering a unique method of monitoring its effectiveness. Additionally, the combination with PTI-122 is being tested in various dosing regimens, which could optimize the treatment's impact on cancer cells while minimizing harm to healthy tissues.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research shows that PSMA-Targeted [In-111]-Labeled Trillium Compounds are absorbed well by prostate cancer tumors and remain there longer than in other parts of the body. This allows the treatment to focus on cancer cells, potentially increasing its effectiveness. Studies have found that these compounds leave healthy tissues quickly, which could lead to fewer side effects. In this trial, some participants will receive the Trillium Compound alone, while others will receive it with PTI-122, a protective agent. Adding PTI-122 may help shield healthy cells during treatment. Early results suggest that using these treatments together could be both effective and manageable for patients with advanced prostate cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

John Babich, PhD

Principal Investigator

Ratio Therapeutics, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

You have undergone a minimum of 30 days' androgen deprivation hormone therapy or another form of hormonal treatment, or are to commence such therapies in the near future.

If you have not had a prior PSMA PET scan, it may be provided as part of the study if you are eligible and have at least two PSMA positive lesions with one soft tissue lesion having an absolute minimum diameter of fifteen millimeters.

You have an Eastern Cooperative Oncology Group performance score between 0 and 2.

Exclusion Criteria

Serum creatinine > 1.5 mg/dL or creatinine clearance ≤50 mL/min by Cockcroft-Gault estimation

Significant intercurrent illness, treatment-related toxicity, or psychiatric illness/social situation that could place the subject at undue risk during study participation, significantly alter study outcomes, or affect subject compliance with study requirements for dosing and evaluation, as determined by the investigator

You are not currently receiving treatment for any other type of cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of PSMA-Targeted [In-111]-Labeled Trillium Compound, with or without PTI-122

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including imaging and blood tests

24 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PSMA-Targeted [In-111]-Labeled Trillium Compound
• PTI-122

How Is the Trial Designed?

Group I: Trillium Compound Alone Experimental Treatment 1 Intervention

Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound

Group II: Trillium Compound + Single Dose PTI-122 Experimental Treatment 2 Interventions

Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound plus single dose of PTI-122 at 5, 10 or 15 mg

Group III: Trillium Compound + Multiple Dose PTI-122 Experimental Treatment 2 Interventions

Single dose of PSMA-Targeted \[In-111\]-Labeled Trillium Compound plus two doses of PTI-122 at the preferred dose level

Who Is Running the Clinical Trial?

Ratio Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

20+

Ratio Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

The FDA has approved 177Lu-PSMA-617 for treating advanced metastatic castrate-resistant prostate cancer (mCRPC), marking a significant advancement in PSMA-targeted therapies.

Various PSMA-targeted radiopharmaceuticals, including both beta and alpha emitters, are in development, with promising results for alpha therapies like 225Ac-PSMA-617, although there are concerns about potential toxicity to salivary and renal tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate specific membrane antigen binding radiopharmaceuticals: Current data and new concepts. Sartor, O., Baghian, A.[2022]

The new 211At-labeled radiotracer, 211At-3-Lu, effectively targets prostate-specific membrane antigen (PSMA) in prostate cancer cells, showing significant uptake in PSMA+ tumors with minimal uptake in non-target cells, indicating its potential for targeted therapy.

In a long-term toxicity study, 211At-3-Lu demonstrated low off-target toxicity and favorable safety profiles, including stable hematopoietic function and positive histopathological outcomes, suggesting it could be a safe and effective treatment option for patients with prostate cancer resistant to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Improved 211At-Labeled Agent for PSMA-Targeted &#945;-Therapy. Mease, RC., Kang, CM., Kumar, V., et al.[2022]

Prostate-specific membrane antigen (PSMA) is a promising target for developing radiopharmaceuticals in treating aggressive prostate cancers, with ongoing clinical trials focusing on PSMA-targeted therapies, particularly using the β-particle-emitting radioisotope 177Lu.

PSMA PET imaging is crucial for evaluating tumor PSMA expression, helping to select the right patients for PSMA-targeted therapies, and studies are exploring PET parameters as predictive and prognostic biomarkers for treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of PET to Appropriately Select Patients for PSMA-Targeted Theranostics. Eshghi, A., Covington, MF., Eshghi, N., et al.[2023]

Citations

1. aacrjournals.org aacrjournals.org/cancerres/article/84/7_Supplement/ND09/742756/Abstract-ND09-Actinium-225-PSMA-Trillium-BAY

Abstract ND09: Actinium-225 -PSMA-Trillium (BAY 3563254 ... Importantly, 111In-PSMA-Trillium showed robust uptake and prolonged retention in tumors, and reduced uptake and relatively fast washout from ...

2. withpower.com withpower.com/trial/early-phase-1-prostatic-neoplasms-11-2022-0e33c

PSMA-Targeted Trillium Compounds + PTI-122 for Prostate ... ... [In-111]-Labeled Trillium Compound will have tolerable side effects & efficacy for patients with Prostate Cancer and Prostate Cancer. Learn more about the study.

3. firstwordpharma.com firstwordpharma.com/story/5843117

Bayer and Vividion Therapeutics to highlight advancing ... In New Drugs on the Horizon session, Bayer will present preclinical and clinical imaging data on actinium-225 (225Ac)-PSMA-Trillium, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12491815/

Current status of radionuclide therapies in metastatic ... Radiation dosimetry and first therapy results with a (124)I/(131)I-labeled small molecule (MIP-1095) targeting PSMA for prostate cancer therapy.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06217822

NCT06217822 | First-in-human Study of 225Ac-PSMA- ... The study treatment 225Ac-PSMA-Trillium, also called BAY3563254, is under development to treat advanced metastatic castration-resistant prostate cancer. It ...

6. adisinsight.springer.com adisinsight.springer.com/drugs/800072921

PSMA Targeted Indium-111 Labeled Trillium Compound PSMA targeted Indium-111 labeled trillium compound is being developed by Ratio Therapeutics for the treatment of prostate cancer.

7. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05773703/

Trial | NCT05773703 Up to four PSMA-Targeted \[In-111\]-Labeled Trillium Compounds will be evaluated. Each compound will be evaluated first without the cytoprotective agent, PTI- ...