Clinical Trial · NCT07197671

Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 for Metastatic Cancer

Overview

Participants with metastatic cancer who are taking anti-PD-1 or anti-PD-L1 therapy will be enrolled to assess the safety of and find the optimal dose for radioactive imaging agents and to explore whether these agents will make current drug therapies work better. Up to 60 participants will be enrolled and can expect to be on study for up to 9 months.

Sponsor

University of Wisconsin, Madison

Phase

Phase 1

Contacts

Paul Harari, MD (STUDY_CHAIR)

Cancer Connect (CONTACT)

clinicaltrials@cancer.wisc.edu

800-622-8922

Justine Bruce, MD (PRINCIPAL_INVESTIGATOR)

Zachary Morris, PhD (STUDY_CHAIR)

Grace Blitzer, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07197671

Drug / Compound

NM600

Isotope(s):

Target(s):

Phospholipid Metabolism

Ligand Class: Small Molecules

NM600

Isotope(s):

Target(s):

Phospholipid Metabolism

Ligand Class: Small Molecules

Eligibility

Inclusion

Participants must have metastatic disease of one of the following types: bile duct cancer, bladder cancer, cervical cancer, colorectal cancer, cutaneous squamous cell cancer, esophageal cancer, head and neck squamous cell carcinoma, kidney cancer, liver cancer, lung cancer, melanoma, merkel cell carcinoma, mesothelioma, stomach cancer, triple-negative breast cancer, or any solid cancer with mismatch repair deficiency.
Participants with histologically or cytologically confirmed squamous cell carcinoma thought to originate from the head and neck region (HNC).
1. Participant must be informed of the investigational nature of the study and must be able to sign a written informed consent.
For the purposes of this study, patients will be considered to have iUPD if they have been on treatment with anti-PD-1 or anti-PD-L1 therapy for any duration of time and, on their most recent standard-of-care imaging, been observed to have evidence of progression when the most recent scans prior to those did not show evidence of progression. Evidence of progression in this context will be defined as a 20 percent or greater increase in the sum of diameters of up to 5 lesions (these lesions will be identified as representative of the distribution of the patient's metastatic disease by the treating physician), the appearance of a new lesion, or the unequivocal progression of any lesion.
Participants must be under treatment with one of the following standard-of-care anti-PD-1 or anti-PD-L1 therapies that is FDA approved for the patient's specific type of metastatic cancer: Pembrolizumab (Keytruda; anti-PD-1 antibody), Nivolumab (Opdivo; anti-PD-1 antibody), Atezolizumab (Tecentriq, anti-PD-L1 antibody), Avelumab (Bavencio; anti-PD-L1 antibody), Durvalumab (Imfinzi; anti-PD-L1 antibody), Cemiplimab (Libtayo; anti-PD-1 antibody), Dostarlimab (Jemperli; anti-PD-1 antibody). The patient must also have iUPD (Immune Unconfirmed Progressive Disease) after most recent imaging studies and be eligible to continue anti-PD-1 or anti-PD-L1 therapy, per the treating physician.

Exclusion

Any ongoing or active infection, including active tuberculosis, hepatitis B or C, or known infection with the human immunodeficiency virus (HIV) that is not well controlled (undetectable viral load by PCR) by anti-retroviral therapy.
The participant is pregnant, breastfeeding, or expecting to conceive or could impregnate someone within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.
1. Other concurrent severe and/or uncontrolled concomitant medical or psychiatric conditions (e.g., active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol, per investigator discretion.
Chemotherapy, radiotherapy, or major surgery within 3 weeks prior to study enrollment (this will be greater than 5 weeks prior to 90Y-NM600 therapy). a. For patients receiving prior radiation therapy, the dose to tumor, kidneys, liver, and bone marrow must be recorded, if available.
The participant is taking strong inducers or inhibitors of CYP450 enzymes or drug transporters that cannot be held from at least 30 days prior to administration of 86Y-NM600 through the final 90Y-NM600 infusion without any expected adverse events. Examples include: clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, phenobarbital, phenytoin, rifampicin, and glucocorticoids.