Phase 1 Study of Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 Therapy for Metastatic Cancer
University of Wisconsin, Madison
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant must be informed of the investigational nature of the study and must be able to sign a written informed consent. 2. Participants with histologically or cytologically confirmed squamous cell carcinoma thought to originate from the head and neck region (HNC). 3. 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 carcin…
Interventions
- Drug90Y-NM600
NM600 is a tumor-selective, pan-cancer, targeted radionuclide therapy (TRT) with theranostic capacity
Location
- UW Carbone Cancer CenterMadison, Wisconsin