Actively Recruiting
Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 for Metastatic Cancer
Led by University of Wisconsin, Madison · Updated on 2026-05-05
60
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
A
Archeus Technologies, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 for Metastatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent
- Have confirmed squamous cell carcinoma from head and neck region
- Have metastatic disease including bile duct, bladder, cervical, colorectal, cutaneous squamous cell, esophageal, head and neck, kidney, liver, lung, melanoma, merkel cell, mesothelioma, stomach, triple-negative breast cancer, or any solid cancer with mismatch repair deficiency
- Currently receiving FDA-approved anti-PD-1 or anti-PD-L1 therapy for metastatic cancer with immune-unconfirmed progressive disease (iUPD)
- Eligible to continue anti-PD-1 or anti-PD-L1 therapy as determined by treating physician
- May also be receiving Ipilimumab or Tremelimumab with immune checkpoint inhibition
- Have shown progression or iUPD on at least one front-line therapy for metastatic disease
- Have at least one measurable tumor detectable on imaging
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 6 months
- Negative urine pregnancy test within 7 days prior to Y-NM600 if able to become pregnant
- Use medically acceptable birth control during study and for 6 months after last dose if able to become pregnant
- Use contraception or abstain from intercourse if able to impregnate a partner for specified durations
- Adequate kidney function (creatinine clearance >60 ml/min)
- Adequate liver function with total bilirubin ≤1.5 times upper limit of normal and AST/ALT ≤3 times upper limit
- Adequate blood counts without recent GM-CSF or transfusion
- Willing to undergo 2 core needle biopsies if in Phase 1a
- Adequate uptake of 86Y-NM600 on PET CT imaging
- No new grade 2 or higher toxicities unrelated to 86Y-NM600 by day 7 after infusion
- No new grade 3 or higher toxicities by day 7 after 86Y-NM600 infusion
You will not qualify if you...
- Severe or uncontrolled medical or psychiatric conditions that pose safety risks or affect study compliance
- Taking strong CYP450 inducers or inhibitors that cannot be stopped before and during study treatment
- Chemotherapy, radiotherapy, or major surgery within 3 weeks before enrollment
- Pregnant, breastfeeding, or planning to conceive or impregnate during study and 6 months after last dose
- Active infections including tuberculosis, hepatitis B or C, or uncontrolled HIV
- Receiving other systemic anti-cancer or investigational treatments besides specified immune therapies
- History of second primary cancer within 2 years except certain treated skin or prostate cancers
- Prior total body or hemibody irradiation or systemic radioisotope therapy (except for benign thyroid disease)
- Conditions requiring immunosuppression excluding stable corticosteroid use for rheumatologic or endocrine diseases
- Ongoing dialysis
- Medical conditions causing uncontrolled bleeding
- Genetic conditions predisposing to radiation toxicity
- Implanted defibrillator or pacemaker with dependency
- Prolonged QTcF interval or use of QT-prolonging medications
- Unable to provide independent, legal, informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UW Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
C
Cancer Connect
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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