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A Phase I/II Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer

Phase 1/Phase 2
21 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

A Phase I/II Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer

Inclusion Criteria:

- To be included in this study, patients should be eligible for enrollment into
protocol 11-016 (therapy with the DSTP3086S ADC) or meet all of the following

- Patients meeting the criteria for enrollment on research protocol 11-016 to receive
DSTP3086S ADC (therapeutic ADC based on MSTP2109A) will be the preferred patients for
this study. Patients that are to receive DSTP3086S will not be injected with
DSTP2086S until imaging with 89Zr-DFOMSTP2109A is finished, approximately 1 week.

- Adult male > 21years of age

- Visible lesions by either CT, bone scan or MRI consistent with metastatic disease

- Metastatic progressive disease

- Imaging modalities:

- Bone scan: new osseous lesion and/or MRI or CT: An increase in measurable soft tissue
disease or the appearance of new sites of disease.


- PSA changes over range of value 26%

- Patients with histologically confirmed prostate cancer at MSKCC

- STEAP1 antigen positive tissue known from prior IHC testing or if STEAP1 status is
not known archival sample will be sent to Genentech for IHC. Samples need to be
positive, when feasible metastatic lesions will be tested preferentially rather than
the primary.

- Performance status of 60 or higher (Karnofsky scale) (Appendix A)

- Ability to understand and willingness to sign a written informed consent document

- PSA levels to be taken within 2 weeks of antibody administration.

Exclusion Criteria:

- Patients meeting any of the following exclusion criteria will not be eligible for
study entry:

- Previous anaphylactic reaction to human, humanized or chimeric antibody

- Hematologic

- Platelets <75K/mcL

- ANC <1.0 K/mcL

- Hepatic laboratory values

- AST/ALT >2.5 x ULN

- Renal laboratory values

- Bilirubin >1.5 x ULN (institutional upper limits of normal)

- eGFR < 30mL/min/1.73m2

- Patients with history of hypersensitivity reaction to any component of
89Zr-DFOMSTP2109A, including DFO

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:


Outcome Description:

Antibody imaging will be considered feasible if 75% of the patients are antibody-imaging-positive. We will enroll 6 patients (cohort 1A) at the 10mg dose level for an initial decision on feasibility. If 4 or more of these patients have 20% or more of their active lesions detectable by 89Zr-DFO-MSTP2109A then we will consider the agent feasible for imaging, otherwise we will proceed to cohort 1B. If the true feasibility rate is 40%, this rule will affords more than 82% chance that cohort 1B will be opened for enrollment; this probability is less than 17% if the true feasibility is 75%.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jorge Carrasquillo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2013

Completion Date:

January 2015

Related Keywords:

  • Prostate Cancer
  • 89Zr-DFO-MSTP2109A
  • tracer
  • pet scan
  • 12-178
  • Prostatic Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021