Metastatic CancerPhase 1NCT07197671
Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 for Metastatic Cancer
A Phase 1 study testing 90Y-NM600 in people with Metastatic Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- 90Y-NM600
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be informed of the investigational nature of the study and must be able to sign a written informed consent.
- Participants with histologically or cytologically confirmed squamous cell carcinoma thought to originate from the head and neck region (HNC).
- Participants must have metastatic solid malignancy, non-hematological.
- Participants must be under treatment with one of the following FDA-approved standard-of-care anti-PD-1 or anti-PD-L1 therapies: 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). Participants may be on additional FDA-approved immunotherapy treatments including anti-CTLA4 therapies or anti-LAG-3 therapies in addition to the anti-PD-1 or anti-PD-L1 backbone therapy. The specific additional therapies allowed are: Ipilimumab (Yervoy; anti-CTLA4 antibody), Tremelimumab (Imjudo; anti-CTLA4 antibody), or Relatlimab (Opdualag; anti-LAG-3).
- Participants must have stable disease or concern for progression of their disease on most recent imaging scans yet be continuing on anti-PD1 or anti-PD-L1 therapy, per the treating physician. Participants may continue on anti-CTLA-4 or anti-LAG-3 ICIs if they have already been taking these when assessed to have stable or potentially progressive disease on most recent imaging. Subjects may also discontinue anti-CTLA-4 or anti-LAG-3 ICIs and remain eligible as long as they meet above criteria and continue the anti-PD-1 or anti-PD-L1 component of therapy that they have already been taking.
- Participants must have at least one evaluable (measurable) tumor that is radiographically detectable.
Show all 22Show fewer
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
- 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.
- Participants who are not surgically or medically sterile must agree to use an acceptable method of contraception, such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence during the study participation and for 6 months after last dose of study drug. Participants who could impregnate their sexual partners must also abstain from intercourse for three weeks after Y-NM600 treatment and agree to use condoms at least 2 months after the last dose of this drug. Participants who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be people who could become pregnant.
- The participant has adequate renal function as defined by Cockcroft-Gault calculated creatinine clearance >40 ml/min
- The subject has adequate hepatic function as defined by:
- total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3.0 times the ULN
- The participant has adequate hematologic function without Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) injection or transfusion in the prior 7 days, as evidenced by:
- an absolute neutrophil count (ANC) greater than or equal to 2000 / μL
- hemoglobin greater than or equal to 8 g/dL
- platelets greater than or equal to 100,000 / μL
- For phase 1a, participant must be willing to undergo 2 core needle biopsies that are accessible via ultrasound and/or clinical biopsy.
- Adequate uptake of 86Y-NM600 (2x red bone marrow) on PET CT imaging.
- No grade 2 toxicities that are new compared to baseline and lack a possible alternative explanation (e.g., underlying disease or another known cause) were noted by Day 7 after the 86Y-NM600 infusion. Toxicities with at least a possibly related attribution to disease and/or another cause-even if also considered at least possibly related to 86Y-NM600-are permitted.
- No Grade ≥ 3 toxicities that are new compared to baseline were noted by day 7 after 86Y-NM600 infusion.
Who cannot join
- 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.
- 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.
- Chemotherapy, radiotherapy, or major surgery within 3 weeks prior to study enrollment (this will be greater than 5 weeks prior to 90Y-NM600 therapy).
- For patients receiving prior radiation therapy, the dose to tumor, kidneys, liver, and bone marrow must be recorded, if available.
- 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.
- 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.
Show all 18Show fewer
- Concurrent treatment with any other systemic anti-cancer or investigational agents other than an anti-PD-1, anti-PD-L1, anti-CTLA-4, or anti-LAG-3 antibody. Subjects cannot be receiving concomitant chemotherapy, experimental therapy or any other therapy not otherwise outlined by the trial for the purposes of anti-cancer treatment.
- Palliative external beam radiation therapy may be delivered to patients during this study if deemed necessary and safe by the treating physician.
- Participants can be receiving dual immune checkpoint inhibition with an anti-CTLA-4 antibody or an anti-LAG-3 antibody in addition to an anti-PD-1 or anti-PD-L1 therapy.
- Patients with a history of or concurrent second primary malignancy within 2 years to study enrollment are excluded, with the exception of patients who have had definitive treatment of a primary skin basal cell, skin squamous cell carcinomas, or localized low or intermediate risk prostate cancer - these subjects are eligible 3 months after completion of definitive treatment for that prior cancer.
- Participants that have had total body or hemibody irradiation, or have had prior systemic radioisotope therapy (except for benign thyroid disease)
- Any condition requiring the use of immunosuppression, excluding rheumatologic conditions or endocrine conditions treated with stable doses of corticosteroids (equivalent to prednisone 10 mg daily)
- Ongoing hemodialysis or peritoneal dialysis
- Any known medical condition that predisposes the subject to uncontrolled bleeding such as hemophilia or clotting factor deficiencies
- Participants with known genetic conditions causing pre-disposition to RT toxicity (i.e.: Li-Fraumeni, ataxia telangiectasia mutated (ATM) deficiency, active scleroderma, active inflammatory bowel disease, active systemic lupus)
- Patients with an implanted defibrillator or with an implanted pacemaker and pacemaker dependency for rate or rhythm control
- Patients with repeated demonstration on two EKGs of a QTcF interval greater than 470 milliseconds or use of medications known to prolong the QT/QTc interval
- Participants who cannot provide independent, legal, informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UW Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: Phase 1 Study of Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 Therapy for Metastatic Cancer
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.
Read the detailed description
This is a safety study of 86Y-NM600 and 90Y-NM600 and a dose finding study for 90Y-NM600 in patients with metastatic cancers who are receiving an anti-PD-1 or anti-PD-L1 therapy, have persistent disease that is stable or potentially progressive, and will be continuing anti-PD-1 or anti-PD-L1 therapy for another imaging interval per the treating physician. The imaging agent 86Y-NM600 will be injected, and serial positron-emission tomography (PET)/computed tomography (CT) imaging will be performed to enable dosimetry calculations that will be used to determine eligibility for 90Y-NM600.
Phase 1a of the study (dose finding) will enroll 6-24 participants into a 3x3 dose finding plan where 3 participants start at Level 1 (below) and the number of participants with dose limiting toxicities (DLTs) will inform the next 3 participants:
- 0/3 Escalate to next higher dose level*
- 1/3 Accrue additional 3 patients at current dose level
- 1/3 + 0/3 Escalate to next higher dose level*
- 1/3 + ≥ 1/3 End phase 1a or de-escalate to dose level -1 if at dose level 1
- ≥ 2/3 End phase 1a or de-escalate to dose level -1 if at dose level 1
Dosing Plan:
- Level -1: 20 millicurie (mCi) x 1
- Level 1: 35 mCi x1
- Level 2: 70 mCi x1
- Level 3: 105 mCi x1
- Level 4: 140 mCi x1
Phase 1b (expansion cohort) may enroll up to an additional 36 participants (18 into a single dose cohort, 18 into a multi-dose cohort) with metastatic cancer.
The primary endpoints are to determine the safety of administering 86Y-NM600 for imaging and 90Y-NM600 for delivering radiation in patients with metastatic cancer who are receiving standard-of-care anti-PD-1 or anti-PD-L1 therapy.
- Conditions
- Metastatic Cancer
- Being tested
- 90Y-NM600
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90Y-NM600Drug
Also called alkylphosphocholine (APCh) analog
NM600 is a tumor-selective, pan-cancer, targeted radionuclide therapy (TRT) with theranostic capacity
| Study group | Role | What they receive |
|---|---|---|
| Phase 1A: Dose Level -1 | Experimental | 20 mCi x 1 90Y-NM600 Receives: Drug: 90Y-NM600 |
| Phase 1A: Dose Level 1 | Experimental | 35 mCi x 1 90Y-NM600 Receives: Drug: 90Y-NM600 |
| Phase 1A: Dose Level 2 | Experimental | 70 mCi x 1 90Y-NM600 Receives: Drug: 90Y-NM600 |
| Phase 1A: Dose Level 3 | Experimental | 105 mCi x 1 90Y-NM600 Receives: Drug: 90Y-NM600 |
| Phase 1A: Dose Level 4 | Experimental | 140 mCi x 1 90Y-NM600 Receives: Drug: 90Y-NM600 |
| Phase 1B: Single Dose | Experimental | Informed by Phase 1A Receives: Drug: 90Y-NM600 |
| Phase 1B: Multi-dose | Experimental | Informed by Phase 1A and Single Dose Phase 1B Receives: Drug: 90Y-NM600 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities greater than or equal to Grade 3 at least possibly related to 86Y-NM600
Toxicities greater than or equal to Grade 3 at least possibly related to 86Y-NM600 by day 7 (greater than 10 half-lives of 86Y) after 86Y-NM600 injection, as defined by the NCI CTCAE version 5.0.
Measured: baseline screening, Day 7 after 86Y-NM600 injection
Toxicities greater than or equal to Grade 3 at least possibly related to 90Y-NM600
Toxicities greater than or equal to Grade 3 at least possibly related to 90Y-NM600 by day 42 after final 90Y-NM600 injection, as defined by the NCI CTCAE version 5.0.
Time points of investigation include:
- baseline screening
- Phase 1A: post injection week 1, week 2, week 3, week 4
- Phase 1B: 7 days after each injection, 30 days and 42 days after final injection
Measured: up to 9 months on study
Secondary outcomes (7)
Pharmacokinetics of Y-NM600: Blood concentration verse time curve
Blood concentration verse time curve, blood draws at estimated Cmax 3-5 min after end of infusion, 0.5 hours, *2.0 hours, 4.0 hours, 24 hour, and *48 hours after infusion (*Phase 1A only)
Measured: 3-5 min after end of infusion, 0.5 hours, *2.0 hours, 4.0 hours, 24 hour, and *48 hours after infusion (*Phase 1A only)
Pharmacokinetics of Y-NM600: Time to reach maximum concentration of Y-NM600 in Blood
Blood draws at estimated Cmax 3-5 min after end of infusion, 0.5 hours, *2.0 hours, 4.0 hours, 24 hour, and *48 hours after infusion (*Phase 1A only)
Measured: Blood draws at estimated Cmax 3-5 min after end of infusion, 0.5 hours, *2.0 hours, 4.0 hours, 24 hour, and *48 hours after infusion (*Phase 1A only)
Pharmacokinetics of Y-NM600: Blood Radioactivity from Y-NM600
Blood draws at estimated Cmax 3-5 min after end of infusion, 0.5 hours, *2.0 hours, 4.0 hours, 24 hour, and *48 hours after infusion (*Phase 1A only)
Measured: Blood draws at estimated Cmax 3-5 min after end of infusion, 0.5 hours, *2.0 hours, 4.0 hours, 24 hours, and *48 hours after infusion (*Phase 1A only)
Pharmacokinetics of Y-NM600: Physiological Half-life of Y-NM600
Phase 1a: Blood draws at estimated Cmax 3-5 min after end of infusion (+/- 5 min), 0.5 hours (+/- 15 min), 2.0 hours (+/- 30 min), 4.0 hours (+/- 30 min), 24 hours (+/- 120 min), and 48 hours (+/- 120 min) after infusion.
Phase 1b: Blood draws at estimated Cmax 3-5 min after end of infusion (+/- 5 min), 0.5 hours (+/- 15 min), 4.0 hours (+/- 30 min), and 24 hours (+/- 120 min) after infusion.
Cumulative urine collection will be done for 6 hours with specific samples collected and pooled at 0.5 hours (+/- 15 min), 3 hours (+/- 30 min), and at 5 hours (+/- 30 min) after infusion.
Measured: Blood draws at estimated Cmax 3-5 min after end of infusion, 0.5 hours, *2.0 hours, 4.0 hours, 24 hours, and *48 hours after infusion (*Phase 1A only)
Proportion of Participants with 2-fold or greater uptake of 86Y-NM600 in tumor site compared to red bone marrow
Assessed via PET/CT 48-72 hours after 86Y-NM600 infusion as Maximum Standardized Uptake Value (SUVmax) at tumor sites previously identified by standard of care imaging and at a site of red bone marrow.
Measured: 48-72 hours after 86Y-NM600 infusion
Overall Response Rate (ORR) by iRECIST at 12 weeks after final 90Y-NM600 injection (D1)
ORR will include iCR and iPR and will be determined as per iRECIST, by investigator assessment.
Measured: baseline, standard-of-care imaging 12 weeks after D1
Safe and Effective Dose Level for Phase 1B
A recommended phase 1b single treatment dose level is based on the following criteria: 1) a dose level resulting in less than 33 percent of participants with Dose Limiting Toxicities by 42 days after final 90Y-NM600 injection, 2) the dose level with the greatest ORR among dose levels that meet criteria 1 and the lower dose level if ORR is equal at two dose levels, and 3) the highest dose level that meets criteria 1 if no participants exhibit ORR in any regimen that meets criterion 1.
For the multi-dose expansion cohort, the recommended dose will be the single treatment expansion dose level or the next highest dose level for which OLINDA calculations from PET/CT imaging at 48-72 hours after 86Y-NM600 for all enrolled patients predict cumulative mean doses of less than 23 Gy to the kidney, less than 2 Gy to the red bone marrow, and less than 30 Gy to liver in greater 66 percent of participants following three cycles of 90Y-NM600 at the multi-dose expansion cohort dose level.
Measured: Phase 1A: baseline, Once per week for four weeks after 90Y-NM600 injection and at day 42 after 90Y-NM600 injection, Standard-of-care imaging 8 weeks after D1 of 90Y-NM600
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Nov 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3x3 dose escalation
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Archeus Technologies, Inc., National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Grace Blitzer, MD, Principal investigator, UW Carbone Cancer CenterJustine Bruce, MD, Principal investigator, UW Carbone Cancer CenterZachary Morris, PhD, Study chair, UW Carbone Cancer CenterPaul Harari, MD, Study chair, UW Carbone Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197671
- Sponsor's protocol ID
- 2025-0647
- Other IDs
- P50CA278595-06A1, SMPH/HUMAN ONCOLOGY/HUMAN ONCO, Protocol Version 5/28/2026, UW24136
- Status last verified
- Aug 2026
- First submitted
- 15 Sep 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 Therapy for Metastatic Cancer
- ClinicalTrials.gov ID
- NCT07197671
- Acronym / sponsor ID
- 2025-0647
- Conditions
- Metastatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Archeus Technologies, Inc., National Cancer Institute (NCI)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a safety study of 86Y-NM600 and 90Y-NM600 and a dose finding study for 90Y-NM600 in patients with metastatic cancers who are receiving an anti-PD-1 or anti-PD-L1 therapy, have persistent disease that is stable or potentially progressive, and will be continuing anti-PD-1 or anti-PD-L1 therapy for another imaging interval per the treating physician. The imaging agent 86Y-NM600 will be injected, and serial positron-emission tomography (PET)/computed tomography (CT) imaging will be performed to enable dosimetry calculations that will be used to determine eligibility for 90Y-NM600.
Phase 1a of the study (dose finding) will enroll 6-24 participants into a 3x3 dose finding plan where 3 participants start at Level 1 (below) and the number of participants with dose limiting toxicities (DLTs) will inform the next 3 participants:
- 0/3 Escalate to next higher dose level*
- 1/3 Accrue additional 3 patients at current dose level
- 1/3 + 0/3 Escalate to next higher dose level*
- 1/3 + ≥ 1/3 End phase 1a or de-escalate to dose level -1 if at dose level 1
- ≥ 2/3 End phase 1a or de-escalate to dose level -1 if at dose level 1
Dosing Plan:
- Level -1: 20 millicurie (mCi) x 1
- Level 1: 35 mCi x1
- Level 2: 70 mCi x1
- Level 3: 105 mCi x1
- Level 4: 140 mCi x1
Phase 1b (expansion cohort) may enroll up to an additional 36 participants (18 into a single dose cohort, 18 into a multi-dose cohort) with metastatic cancer.
The primary endpoints are to determine the safety of administering 86Y-NM600 for imaging and 90Y-NM600 for delivering radiation in patients with metastatic cancer who are receiving standard-of-care anti-PD-1 or anti-PD-L1 therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- 3x3 dose escalation
| Arm | Type | Receives |
|---|---|---|
| Phase 1A: Dose Level -1 | Experimental | Drug: 90Y-NM60020 mCi x 1 90Y-NM600 |
| Phase 1A: Dose Level 1 | Experimental | Drug: 90Y-NM60035 mCi x 1 90Y-NM600 |
| Phase 1A: Dose Level 2 | Experimental | Drug: 90Y-NM60070 mCi x 1 90Y-NM600 |
| Phase 1A: Dose Level 3 | Experimental | Drug: 90Y-NM600105 mCi x 1 90Y-NM600 |
| Phase 1A: Dose Level 4 | Experimental | Drug: 90Y-NM600140 mCi x 1 90Y-NM600 |
| Phase 1B: Single Dose | Experimental | Drug: 90Y-NM600Informed by Phase 1A |
| Phase 1B: Multi-dose | Experimental | Drug: 90Y-NM600Informed by Phase 1A and Single Dose Phase 1B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Participant must be informed of the investigational nature of the study and must be able to sign a written informed consent.
- Participants with histologically or cytologically confirmed squamous cell carcinoma thought to originate from the head and neck region (HNC).
- Participants must have metastatic solid malignancy, non-hematological.
- Participants must be under treatment with one of the following FDA-approved standard-of-care anti-PD-1 or anti-PD-L1 therapies: 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). Participants may be on additional FDA-approved immunotherapy treatments including anti-CTLA4 therapies or anti-LAG-3 therapies in addition to the anti-PD-1 or anti-PD-L1 backbone therapy. The specific additional therapies allowed are: Ipilimumab (Yervoy; anti-CTLA4 antibody), Tremelimumab (Imjudo; anti-CTLA4 antibody), or Relatlimab (Opdualag; anti-LAG-3).
- Participants must have stable disease or concern for progression of their disease on most recent imaging scans yet be continuing on anti-PD1 or anti-PD-L1 therapy, per the treating physician. Participants may continue on anti-CTLA-4 or anti-LAG-3 ICIs if they have already been taking these when assessed to have stable or potentially progressive disease on most recent imaging. Subjects may also discontinue anti-CTLA-4 or anti-LAG-3 ICIs and remain eligible as long as they meet above criteria and continue the anti-PD-1 or anti-PD-L1 component of therapy that they have already been taking.
Key exclusion criteria (18 listed)
- 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.
- 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.
- Chemotherapy, radiotherapy, or major surgery within 3 weeks prior to study enrollment (this will be greater than 5 weeks prior to 90Y-NM600 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 90Y-NM600Also: alkylphosphocholine (APCh) analogNM600 is a tumor-selective, pan-cancer, targeted radionuclide therapy (TRT) with theranostic capacity | Drug | Phase 1A: Dose Level -1, Phase 1A: Dose Level 1, Phase 1A: Dose Level 2, Phase 1A: Dose Level 3, Phase 1A: Dose Level 4, Phase 1B: Multi-dose, Phase 1B: Single Dose |
Primary outcome
Toxicities greater than or equal to Grade 3 at least possibly related to 86Y-NM600
Time frame: baseline screening, Day 7 after 86Y-NM600 injection
Toxicities greater than or equal to Grade 3 at least possibly related to 86Y-NM600 by day 7 (greater than 10 half-lives of 86Y) after 86Y-NM600 injection, as defined by the NCI CTCAE version 5.0.
Toxicities greater than or equal to Grade 3 at least possibly related to 90Y-NM600
Time frame: up to 9 months on study
Toxicities greater than or equal to Grade 3 at least possibly related to 90Y-NM600 by day 42 after final 90Y-NM600 injection, as defined by the NCI CTCAE version 5.0. Time points of investigation include: * baseline screening * Phase 1A: post injection week 1, week 2, week 3, week 4 * Phase 1B: 7 days after each injection, 30 days and 42 days after final injection
7 secondary outcomes
Pharmacokinetics of Y-NM600: Blood concentration verse time curve
Time frame: 3-5 min after end of infusion, 0.5 hours, *2.0 hours, 4.0 hours, 24 hour, and *48 hours after infusion (*Phase 1A only)
Pharmacokinetics of Y-NM600: Time to reach maximum concentration of Y-NM600 in Blood
Time frame: Blood draws at estimated Cmax 3-5 min after end of infusion, 0.5 hours, *2.0 hours, 4.0 hours, 24 hour, and *48 hours after infusion (*Phase 1A only)
Pharmacokinetics of Y-NM600: Blood Radioactivity from Y-NM600
Time frame: Blood draws at estimated Cmax 3-5 min after end of infusion, 0.5 hours, *2.0 hours, 4.0 hours, 24 hours, and *48 hours after infusion (*Phase 1A only)
Pharmacokinetics of Y-NM600: Physiological Half-life of Y-NM600
Time frame: Blood draws at estimated Cmax 3-5 min after end of infusion, 0.5 hours, *2.0 hours, 4.0 hours, 24 hours, and *48 hours after infusion (*Phase 1A only)
Proportion of Participants with 2-fold or greater uptake of 86Y-NM600 in tumor site compared to red bone marrow
Time frame: 48-72 hours after 86Y-NM600 infusion
Overall Response Rate (ORR) by iRECIST at 12 weeks after final 90Y-NM600 injection (D1)
Time frame: baseline, standard-of-care imaging 12 weeks after D1
Safe and Effective Dose Level for Phase 1B
Time frame: Phase 1A: baseline, Once per week for four weeks after 90Y-NM600 injection and at day 42 after 90Y-NM600 injection, Standard-of-care imaging 8 weeks after D1 of 90Y-NM600
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes
Related trials for Metastatic Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grace Blitzer, MD principal investigator
UW Carbone Cancer Center
Justine Bruce, MD principal investigator
UW Carbone Cancer Center
Zachary Morris, PhD study chair
UW Carbone Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 90Y-NM600 in people with Metastatic Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicities greater than or equal to Grade 3 at least possibly related to 86Y-NM600 (time frame: baseline screening, Day 7 after 86Y-NM600 injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.