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A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057

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ClinicalTrials.gov Identifier: NCT02916537
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Cancer Targeted Technology

Tracking Information
First Submitted Date  ICMJE September 22, 2016
First Posted Date  ICMJE September 27, 2016
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE September 2016
Actual Primary Completion Date August 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2016)
Adverse event frequency as graded by Common Toxicity Criteria version 4.03 [ Time Frame: 7 days from time of injection ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2016)
  • Organ dosimetry/tissue uptake of CTT1057 as measured by PET/MR imaging of prostate cancer [ Time Frame: Up to six hours from time of injection ]
  • Pharmacokinetic profile of CTT1057 as measured by radiotracer detection in blood samples [ Time Frame: Up to four hours from time of injection ]
  • Level of CTT1057 uptake on PET/MR imaging of localized prostate cancer with PSMA protein expression by immunohistochemistry from subsequent radical prostatectomy specimens [ Time Frame: 12 weeks ]
  • Optimal Standardized Uptake Value (SUV) ratio threshold on CTT1057 PET/MR for discriminating tumor pathology from primary prostate cancer tissue [ Time Frame: 4 hours ]
  • Sensitivity and specificity of CTT1057 PET imaging on a lesion-by-lesion basis as compared with standard imaging in metastatic prostate cancer [ Time Frame: 4 hours ]
  • Number of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans [ Time Frame: 4 hours ]
  • Location of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans [ Time Frame: 4 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057
Official Title  ICMJE A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057, a Small Molecule Inhibitor of Prostate Specific Membrane Antigen (PSMA)
Brief Summary The purpose of this study is to test a novel diagnostic Positron Emission Tomography (PET) imaging agent for safety and biodistribution. The agent binds Prostate Specific Membrane Antigen (PSMA) and is designed to detect prostate tumors.
Detailed Description

The sponsor has developed a PET imaging agent, CTT1057, labeled with 18F, that is based on a small molecule core and targets an extracellular region of PSMA with high affinity. Although comparable to other inhibitors in terms of affinity for PSMA, this unique class of phosphoramidate agents are the only known irreversible PSMA inhibitors. Due to its irreversible binding to PSMA and rapid uptake by PSMA-expressing prostate cancer cells, accumulation at the cancer target is expected to be rapid, specific and sensitive.

Twenty patients will be enrolled in parallel in two cohorts:

  • (Cohort A) Patients with prostate cancer prior to radical prostatectomy (N = 5).
  • (Cohort B) Patients with evidence of metastatic castration-resistant prostate cancer (N = 15)

Participants receive a single intravenous (IV) dose (370 MBq, or 10 mCi) of CTT1057 in this first-in-human trial. Combined PET/MR imaging (prostate + whole body) will be performed following tracer injection. The 5 patients in the pre-prostatectomy cohort will comprise the dosimetry/pharmacokinetic (PK) cohort to establish organ dosimetry and PK profile. Patients in cohort A will undergo planned radical prostatectomy (plus lymph node dissection) within 12 weeks following CTT1057 PET/MR. Patients in cohort B (metastatic prostate cancer) will have the option for metastatic tumor biopsy following CTT1057 PET imaging.

The one-time nominal injected dose will be 370 MBq (10 mCi). Estimated mass dose is 20 µg of CTT1057. Dose will be in a volume of 3 - 5 mL, and will be injected intravenously as a bolus injection.

Vital signs, adverse event assessment, and 12 lead ECGs will be performed on day 1 before and after dosing.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: CTT1057
    Single IV dose (370 MBq, or 10 mCi) of CTT1057 followed by combined PET/MR imaging (prostate + whole body).
  • Procedure: Prostatectomy
    Radical prostatectomy with lymph node dissection
Study Arms  ICMJE
  • Experimental: Cohort A: Pre-prostatectomy patients
    Patients with prostate cancer prior to radical prostatectomy (N = 5). Single IV dose (370 MBq, or 10 mCi). Combined PET/MR imaging (prostate + whole body) will be performed following tracer injection. Patients in cohort A will undergo radical prostatectomy (plus lymph node dissection) within 12 weeks following CTT1057 PET/MR.
    Interventions:
    • Drug: CTT1057
    • Procedure: Prostatectomy
  • Experimental: Cohort B: Metastatic prostate cancer

    Patients with evidence of metastatic castration-resistant prostate cancer (N = 15).

    Single IV dose (370 MBq, or 10 mCi). Combined PET/MR imaging (prostate + whole body) will be performed following tracer injection. Patients in cohort B (metastatic prostate cancer) will have the option for metastatic tumor biopsy following CTT1057 PET imaging.

    Intervention: Drug: CTT1057
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 28, 2017
Actual Primary Completion Date August 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male patients age ≥18 years old
  • Histologically confirmed adenocarcinoma of the prostate
  • Adequate organ function including:
  • - Platelet count of > 50,000/mm3
  • - Neutrophil count of > 1000/mm3
  • - Serum Cr < 1.5 x ULN or estimated GFR > 60 ml/min based upon Cockroft-Gault equation
  • - Proteinuria < 1 g/24 hours based upon 24 hour urine collection or spot urine protein/creatinine ratio
  • - AST and ALT < 2.5 x ULN (< 5 x ULN in patients with known liver metastases)
  • - Total bilirubin < 1.5 x ULN (< 3 x ULN in patients with known/suspected Gilbert's disease)
  • ECOG performance status of 0 or 1
  • Able to provide written informed consent and willing to comply with protocol requirements
  • No contra-indication to MR including severe claustrophobia, incompatible aneurysm clips or cardiac pacemaker
  • For men of childbearing potential, the use of effective contraceptive methods during the trial and within 6 months following radiotracer injection
  • Cohort A only (N = 5 evaluable patients):- Planned radical prostatectomy within 12 weeks following protocol scan
  • - No androgen deprivation, anti-androgen therapy, chemotherapy, or investigational systemic therapy prior to CTT1057 PET imaging
  • Cohort B only:- Presence of at least three distinct metastatic lesions by standard imaging including whole body bone scan + cross-sectional imaging of the abdomen and pelvis obtained within 12 weeks prior to protocol scan
  • - Castration-resistant disease as defined by PCWG2 criteria
  • - Must remain on androgen deprivation therapy for duration of trial if no prior bilateral orchiectomy

Exclusion Criteria:

  • Inadequate venous access per assessment of treating health care provider
  • Receipt of radioisotope within 5 physical half lives prior to trial enrollment
  • Prior treatment with alpha radiation therapy (Radium Ra 223 chloride; Xofigo™) during the previous 60 days
  • Have a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial.
  • Histologic evidence of small cell prostate cancer or neuroendocrine differentiation in > 50% of biopsy tissue
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02916537
Other Study ID Numbers  ICMJE 1057-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cancer Targeted Technology
Study Sponsor  ICMJE Cancer Targeted Technology
Collaborators  ICMJE University of California, San Francisco
Investigators  ICMJE
Study Chair: Beatrice Langton-Webster, PhD Cancer Targeted Technology
PRS Account Cancer Targeted Technology
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP