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NCT07664397 [89Zr]DFO-YS5 Advanced Malignant Solid Neoplasm Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

4 August 2026
8 min read

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Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07664397 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.

MCP evidence snapshot: 4 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07664397 is a hot trial to watch

Advanced Malignant Solid Neoplasm is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07664397 is notable because it evaluates [89Zr]DFO-YS5 in a Phase 1 design sponsored by The University of California, San Francisco. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

FieldIndexed detail
RegistrationNCT07664397
Official titleImaging Study of [89Zr]DFO-YS5 for Cancer Detection
Phase / statusPhase 1 / Not yet recruiting
Intervention[89Zr]DFO-YS5
SponsorThe University of California, San Francisco
GeographyUnited States
Enrollment[object Object]
Primary endpointMean maximum standard uptake value (SUVmax-avg) on Positron Emission Tomography (PET) scan
Endpoint time frameUp to 8 days
Primary completion / readout proxy[object Object]

Protocol design and endpoint interpretation

This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody ([89Zr]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.

Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

  • Mean maximum standard uptake value (SUVmax-avg) on Positron Emission Tomography (PET) scan (Up to 8 days) — A volume of interest (VOI) will be placed around each lesion, and the calculated maximum standard uptake value (SUVmax) will be recorded for each lesion. Adjusted SUVmax data will then be averaged across up to 15 lesions within a given patient (SUVmax-avg) at each time point. In order to avoid clustering effects, analyses will be limited to the five largest osseous metastases, five largest lymph node metastases, and
  • Median intra-tumoral SUVmax (Up to 8 days) — The median and range for intra-tumoral SUVmax within metastatic lesions will be descriptively reported, to assess for intra-tumoral heterogeneity and differences in uptake by site of disease.
  • Tumor-to-background signal (Ratio) (Up to 8 days) — The tumor-to-background signal refers to comparing the standardized uptake value (SUV) of a lesion (tumor) to the SUV of a nearby normal organ or tissue that serves as a "background" reference. The ratio of the tumor-to-background signal on PET scan (normal organ as background uptake values) will be calculated as the SUVmax of tumor divided by the SUV of background organ

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Readout outlook and evidence gap

The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.

Build a living trial monitor: connect to PatSnap MCP Servers and track recruitment, endpoint revisions, projected readouts and new result records without manually reconciling separate databases.

Asset and sponsor context

Drug & Asset MCP profile: [89Zr]DFO-YS5 is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.

Company & Deal Intelligence MCP profile: The University of California, San Francisco is resolved to a normalized organization record in SAN FRANCISCO COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.

White space around this program

  • Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
  • Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
  • Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
  • Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
  • Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.

Bottom line

NCT07664397 provides a focused lens on Advanced Malignant Solid Neoplasm development. Its value will be determined by whether [89Zr]DFO-YS5 can convert the current Phase 1 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

Ready to reproduce this analysis? Explore PatSnap MCP Servers and combine Clinical Trials, Drug & Asset, and Company & Deal Intelligence as reusable building blocks for trial monitoring and SEO-ready clinical reports.

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