Imaging Study of [89Zr]DFO-YS5 for Cancer Detection

NCT07664397 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 26921NCI-2026-04664
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer; Nerve Sheath Tumor; Nerve Sheath Tumors; Solid Tumor Malignancies; Solid Tumor Cancer; Solid Tumor Neoplasms; Advanced Solid Tumor; Bladder Neoplasm; Nerve Sheath Neoplasms; Nerve Sheath Tumor, Nos; Solid Tumor, Adult; Solid Carcinoma

Keywords

Imaging Study

Outcome Measures

Primary Outcomes (3)

• Mean maximum standard uptake value (SUVmax-avg) on Positron Emission Tomography (PET) scan

  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 five largest visceral/soft tissue metastases. Metastatic lesion location, size (bidimensional axial measurement), and SUVmax will be tabulated. This will be conducted for all lesions.

  Up to 8 days

• Median intra-tumoral SUVmax

  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.

  Up to 8 days

• Tumor-to-background signal (Ratio)

  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

  Up to 8 days

Secondary Outcomes (1)

• Proportion of participants with reported treatment-emergent adverse events

  Up to 8 days

Study Arms (1)

Treatment ([89Zr]DFO-YS5)

EXPERIMENTAL

Participants will be administered a single, intravenous microdose (1.0 - 3.0 mCi) of \[89Zr\]DFO-YS5, followed by whole-body positron emission tomography (PET) imaging conducted 120-168 hours after \[89Zr\]DFO-YS5 administration (i.e., on Day 6-8). Participants will be followed for treatment-emergent adverse events for up to 35 days.

Drug: [89Zr]DFO-YS5; Procedure: Positron Emission Tomography (PET)-Magnetic resonance imaging (MRI); Procedure: Positron Emission Tomography (PET)-Computerized tomography (CT)

Interventions

[89Zr]DFO-YS5 DRUG

Given intravenously (IV)

Also known as: 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody

Treatment ([89Zr]DFO-YS5)

Positron Emission Tomography (PET)-Magnetic resonance imaging (MRI) PROCEDURE

Participants may receive a whole-body PET-MRI or a whole body PET-CT

Also known as: PET/MRI, PET-MRI

Treatment ([89Zr]DFO-YS5)

Positron Emission Tomography (PET)-Computerized tomography (CT) PROCEDURE

Participants may receive a whole-body PET-CT or a whole-body PET-MRI

Also known as: PET/CT, PET-CT

Treatment ([89Zr]DFO-YS5)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm.
• At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)/CT (scan imaging as documented in the medical record). Exception: For participants with localized bladder cancer (pre-cystectomy), lesions smaller than 1 centimeter (cm) are permitted, provided there is cystoscopic confirmation of a bladder mass.
• Clinically able to undergo PET-CT imaging or PET-MRI.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50% (see Appendix 1).
• Adequate organ function as defined below:
• Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits).
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)): ≤ 3 x ULN.
• Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)): ≤ 3 x ULN.
• Estimated creatinine clearance: ≥ 60 mL/min, calculated using the Cockcroft-Gault equation.
• Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before administration of \[89Zr\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries). The result of the urine or serum pregnancy test must be negative in order to initiate the \[89Zr\]DFO-YS5 administration. If a urine pregnancy test is positive or equivocal, a confirmatory a serum pregnancy test is required. The individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is an unknown but potential risk for adverse effects in the unborn child secondary to treatment of the study participant with \[89Zr\]DFO-YS5.
• Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia) or PET-MRI (e.g., implanted devices, metallic objects, or other implants). Participants must be able to undergo either PET-CT or PET-MRI.
• Individuals who do not agree to follow the below contraception requirements:
• Females of reproductive potential (defined below) must agree to use two forms of contraception, consisting of a barrier method (such as condoms) in combination with a secondary complementary method (such as hormonal, Intrauterine device (IUD), etc.), or strict abstinence, for the duration of study participation and for 1 month after administration of \[89Zr\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).
• Hypersensitivity to \[89Zr\]DFO-YS5 or any of its excipients.
• Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.

Sponsors & Collaborators

• Robert Flavell, MD, PhD: lead
• Kyntra Bio: collaborator
• Fortis Therapeutics, Inc.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Nerve Sheath Neoplasms; Pyloric Stenosis, Hypertrophic

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Robert Flavell, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Aslam

CONTACT

877-827-3222; Maya.Aslam@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)