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Adjusted LOA
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YS5 antibody · 1 trial · 2 indications
For Cohort A, the optimal time point will be selected based on optimal maximun Standardized uptake value (SUVmax) of metastatic lesions, and ratio of SUVmax to blood pool. Due to the limited samples, the investigator will use all available lesions without considering the location of the lesions or the possible intra-correlation of the lesions from the same participant.
For Cohort B, the optimal dose of antibody will be selected based on the optimal SUVmax of metastatic lesions, and ratio of SUVmax to blood pool. Due to the limited samples, the investigator will use all available lesions without considering the location of the lesions or the possible intra-correlation of the lesions from the same participant.
Sensitivity is the probability that a test will indicate disease among those with the actual disease: True Positive / (True Positive + False Negative). Lesions will be graded on a semi-quantitative scale ranging from 1-5 as is common for 89Zr-antibody human imaging studies (1 = no uptake, 2 = probably no uptake, 3 = equivocal, 4 = probably positive, 5 = definitely positive). Using as a cut-off to 4 or 5 on the semi-quantitative scale, the sensitivity of 89Zr-DFO-YS5 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan. The sensitivity estimate will be based on lesion level without considering the location of the lesions or the possible intra-correlation of the lesions from the same patient.
The median and range of SUVmax across all metastatic lesions per participant will be descriptively reported using mediastinal blood pool and normal organ as background uptake values will be reported with range of SUVmax.
The average SUVmax-ave across all metastatic lesions per participant will be descriptively reported using mediastinal blood pool and normal organ as background uptake values for all cohorts will be reported with 95% confidence intervals
| Arm | Type | Description |
|---|---|---|
| Cohort A: 89Zr-DFO-YS5 | EXPERIMENTAL | Participants receive one dose of 89Zr-DFO-YS5 up to 3 millicurie (mCi), and undergo a whole body PET performed at 1-4 hours, approximately 20-28 hours, 48-96 hours, and 120-168 hours post injection for up to 4 scans total. The optimized scan time will be used for imaging in cohorts B and C. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression. |
| Cohort B: 89Zr-DFO-YS5, YS5 antibody | EXPERIMENTAL | Participants receive either a 20mg or 50mg dose of YS5 prior to imaging and administration of one dose of up to 3 millicurie (mCi) 89Zr-DFO-YS5 and then complete a single whole body PET scan at the optimal time determined in Cohort A. The optimal dose of unmodified YS5 antibody will be used in the following cohorts C \& D. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression. |
| Cohort C: 89Zr-DFO-YS5, Optimal dose YS5 antibody | EXPERIMENTAL | Participants receive optimal dose of YS5 antibody prior to imaging and administration of one dose of up to 3 millicurie (mCi) 89Zr-DFO-YS5 and then complete a single whole body PET scan at the optimal time determined in Cohort A. Participants have the option to receive a repeat 89Zr-DFO-YS5 PET at the time of disease progression. |
| Name | Type | Description |
|---|---|---|
| 89Zr-DFO-YS5 | DRUG | 3 mCi will be administered intravenously |
| YS5 antibody | BIOLOGICAL | 20 or 50 mg administered intravenously |
| Positron Emission Tomography (PET)/Computerized tomography (CT) | PROCEDURE | Imaging which combines a CT scan and a PET scan |
| Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI) | PROCEDURE | Imaging which combines an MRI scan and a PET scan |
Inclusion Criteria: 1. Participants must have histologically or cytologically confirmed metastatic, castration resistant prostate cancer (mCRPC). 2. Age \>=18 years 3. Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Karnofsky \>60%). 4. Demonstrates adequate organ function as def...
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YS5 antibody is an investigational monoclonal antibody being studied for use in prostate cancer, specifically in men with metastatic castration-resistant prostate cancer. It is currently in Phase 1 clinical development as a PET imaging agent to visualize tumors. The drug is being evaluated in a clinical trial in the United States.
YS5 antibody is a monoclonal antibody designed to bind to a target on prostate cancer cells, enabling PET imaging of tumors. The specific molecular target is not disclosed in the available information. The antibody is conjugated with a radioactive tracer, 89Zr-DFO, to allow visualization of cancer lesions during imaging.
YS5 antibody is being developed by United Therapeutics Corporation, a biopharmaceutical company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting a Phase 1 clinical trial of this investigational antibody for prostate cancer imaging in the United States.
YS5 antibody is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is active but not recruiting participants, with a planned enrollment of 30 patients with prostate cancer.
YS5 antibody is being evaluated in one active Phase 1 clinical trial with the identifier NCT05245006. The study, titled "PET Imaging Study of 89Zr-DFO-YS5 in Men With Prostate Cancer," is enrolling 30 participants with prostate cancer or metastatic castration-resistant prostate cancer in the United States. The trial is not randomized or double-blinded.
YS5 antibody is the investigational drug being studied, and in the clinical trial it is administered as the radiolabeled conjugate 89Zr-DFO-YS5. The 89Zr-DFO portion is a radioactive tracer attached to the antibody for PET imaging purposes. The trial specifically evaluates this conjugated form for imaging prostate cancer.