NCT07197671

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

Phase 1 Study of Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 Therapy for Metastatic Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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 anti-PD-1 or anti-PD-L1 therapy and have immune-unconfirmed progressive disease (iUPD). 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 iUPD metastatic cancer who are receiving standard-of-care anti-PD-1 or anti-PD-L1 therapy.

Conditions

• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	90Y-NM600	NM600 is a tumor-selective, pan-cancer, targeted radionuclide therapy (TRT) with theranostic capacity

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-09-29
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study