90Y-NM600 for Metastatic Cancer

Overseen By Cancer Connect

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Wisconsin, Madison

Must be taking: Anti-PD-1, Anti-PD-L1

Must not be taking: CYP450 inducers, inhibitors

Disqualifiers: Uncontrolled infection, Diabetes, Pregnancy, others

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

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with metastatic cancer, aiming to determine if adding a radioactive imaging agent (Y-NM600) can enhance the effectiveness of current cancer drugs and identify the optimal dose. The trial targets those whose cancer continues to spread despite receiving specific immune therapies like Keytruda or Opdivo. Suitable candidates include individuals with metastatic cancers such as lung, liver, or bladder cancer, who have experienced cancer progression on recent scans but are still undergoing their current cancer treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

You can continue taking your current anti-PD-1 or anti-PD-L1 therapy, as well as Ipilimumab or Tremelimumab, during the trial. However, you must stop taking any strong inducers or inhibitors of CYP450 enzymes or drug transporters at least 30 days before the trial and throughout its duration.

Is there any evidence suggesting that 90Y-NM600 is likely to be safe for humans?

Research has shown that 90Y-NM600 has been tested in animals, specifically mice, with promising results. In these studies, mice with certain types of tumors treated with 90Y-NM600 experienced tumor shrinkage and lived longer. Importantly, no major safety concerns emerged in these animal studies.

However, this trial is in an early stage, meaning limited information exists about human reactions to the treatment. Early-stage trials like this one focus on determining the right dose and assessing safety for humans. Since 90Y-NM600 is not yet approved for human use, participants will help researchers learn about its safety in humans.

Considering joining the trial offers a chance to contribute to important research while being closely monitored by a medical team. They will watch for any side effects and adjust the treatment if needed. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about 90Y-NM600 for metastatic cancer because it employs a novel approach using a radioactive isotope, yttrium-90, that targets cancer cells more precisely. Unlike traditional chemotherapy, which can affect both healthy and cancerous cells, 90Y-NM600 is designed to deliver radiation directly to tumors, potentially reducing side effects. The treatment also offers flexibility in dosing, with different levels being tested to find the most effective and safe dose. This targeted radiotherapy could lead to better outcomes for patients with metastatic cancer by focusing on the disease more accurately and reducing harm to healthy tissues.

What evidence suggests that 90Y-NM600 could be an effective treatment for metastatic cancer?

Research has shown that 90Y-NM600 can be effective against certain tumors. In studies with mice, this treatment stopped tumors from growing and increased survival, particularly in a type of non-Hodgkin lymphoma called T-cell NHL. It even showed potential for long-term remission, suggesting the body might learn to fight the cancer independently. The treatment targets cancer cells with radiation, making the tumor environment less suitable for growth. Although results in prostate cancer were less encouraging, the treatment might still aid patients receiving immunotherapy by boosting their immune system's response to tumors. Participants in this trial will receive different dosages of 90Y-NM600 to evaluate its safety and effectiveness. ^{1 2 5 6 7}

Who Is on the Research Team?

Grace Blitzer, MD

Principal Investigator

UW Carbone Cancer Center

Justine Bruce, MD

Principal Investigator

UW Carbone Cancer Center

Zachary Morris, PhD

Principal Investigator

UW Carbone Cancer Center

Paul Harari, MD

Principal Investigator

UW Carbone Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic cancer who are currently being treated with anti-PD-1 or anti-PD-L1 therapies. The study aims to include up to 60 participants, and they will be part of the trial for as long as 9 months.

Inclusion Criteria

Participants must have at least one evaluable (measurable) tumor that is radiographically detectable.

Participants must have a life expectancy of at least 6 months.

People who could become pregnant have a confirmed negative urine pregnancy test within 7 days prior to receiving Y-NM600.

Exclusion Criteria

I have not had any of the specific treatments or conditions that would exclude me.

The participant is pregnant, breastfeeding, or expecting to conceive or could impregnate someone within the projected duration of the trial.

I do not have conditions that require immunosuppression, ongoing dialysis, have a genetic condition linked to radiation toxicity, use a pacemaker or defibrillator, have heart rhythm problems, or issues with providing consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1A: Dose Finding

Participants receive escalating doses of 90Y-NM600 to determine the optimal dose

4 weeks

Weekly visits for 4 weeks

Phase 1B: Expansion Cohort

Participants receive single or multiple doses of 90Y-NM600 based on Phase 1A results

6 weeks

Visits at 7 days, 30 days, and 42 days after final injection

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Standard-of-care imaging follow-up at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Y-NM600

Trial Overview

The trial is testing a radioactive imaging agent called Y-NM600 in patients already receiving anti-PD-1 or anti-PD-L1 treatments. It seeks to determine the safety and optimal dosage of Y-NM600 and if it enhances existing therapies.

How Is the Trial Designed?

Group I: Phase 1B: Single Dose Experimental Treatment 1 Intervention

Informed by Phase 1A

Group II: Phase 1B: Multi-dose Experimental Treatment 1 Intervention

Informed by Phase 1A and Single Dose Phase 1B

Group III: Phase 1A: Dose Level 4 Experimental Treatment 1 Intervention

140 mCi x 1 90Y-NM600

Group IV: Phase 1A: Dose Level 3 Experimental Treatment 1 Intervention

105 mCi x 1 90Y-NM600

Group V: Phase 1A: Dose Level 2 Experimental Treatment 1 Intervention

70 mCi x 1 90Y-NM600

Group VI: Phase 1A: Dose Level 1 Experimental Treatment 1 Intervention

35 mCi x 1 90Y-NM600

Group VII: Phase 1A: Dose Level -1 Experimental Treatment 1 Intervention

20 mCi x 1 90Y-NM600

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Archeus Technologies, Inc.

Collaborator

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36002185/

Antitumor efficacy of 90Y-NM600 targeted ... - PubMed

Conclusions: Our data suggest that the combination of 90Y-NM600 TRT and PD-1 blockade therapy is ineffective in these prostate cancer models due to the ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07197671

NCT07197671 | Y-NM600 in Patients Receiving Anti-PD-1 ...

The primary endpoints are to determine the safety of administering 86Y-NM600 for imaging and 90Y-NM600 for delivering radiation in patients ...

3.

nature.com

nature.com/articles/s42003-019-0327-4

90Y-NM600 targeted radionuclide therapy induces ...

Mice bearing T-cell NHL tumors treated with 90 Y-NM600 experienced tumor growth inhibition, extended survival, and a high degree of cure with immune memory.

4.

jitc.bmj.com

jitc.bmj.com/content/10/8/e005060

Antitumor efficacy of 90 Y-NM600 targeted radionuclide ...

Results 90Y-NM600 TRT was safe at doses that elicited a moderate antitumor response. TRT had multiple effects on the tumor microenvironment ...

5.

jnm.snmjournals.org

jnm.snmjournals.org/content/60/11/1622

Preclinical Characterization of 86/90Y-NM600 in a Variety ...

IMPLICATIONS FOR PATIENT CARE: 90Y-NM600 may improve outcomes of patients who are undergoing immunotherapy by immunomodulating the tumor ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9413196/

Antitumor efficacy of 90Y-NM600 targeted radionuclide ...

This work is the first to demonstrate that 90Y-NM600 can be safely used in murine prostate tumors. We estimated that dose to the tumor was higher or comparable ...

7.

jitc.bmj.com

jitc.bmj.com/content/12/4/e008760

Myeloid-derived suppressor cells attenuate the antitumor ...

Here, we explored the use of a novel TRT, 90 Y-NM600, specifically in combination with ADT, in murine prostate tumor models.