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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CTT1057

Prostatectomy

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, prostate specific membrane antigen, prostate neoplasms, metastatic prostate cancer, prostatic hyperplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort A: Pre-prostatectomy patients

Cohort B: Metastatic prostate cancer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adverse event frequency as graded by Common Toxicity Criteria version 4.03

Secondary Outcome Measures

Organ dosimetry/tissue uptake of CTT1057 as measured by PET/MR imaging of prostate cancer

Pharmacokinetic profile of CTT1057 as measured by radiotracer detection in blood samples

Level of CTT1057 uptake on PET/MR imaging of localized prostate cancer with PSMA protein expression by immunohistochemistry from subsequent radical prostatectomy specimens

Optimal Standardized Uptake Value (SUV) ratio threshold on CTT1057 PET/MR for discriminating tumor pathology from primary prostate cancer tissue

Sensitivity and specificity of CTT1057 PET imaging on a lesion-by-lesion basis as compared with standard imaging in metastatic prostate cancer

Number of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans

Location of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans

Full Information

NCT ID

NCT02916537

First Posted

September 22, 2016

Last Updated

November 1, 2017

Sponsor

Cancer Targeted Technology

Collaborators

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT02916537

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

September 2016 (undefined)

Primary Completion Date

August 28, 2017 (Actual)

Study Completion Date

August 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cancer Targeted Technology

Collaborators

University of California, San Francisco

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostate cancer, prostate specific membrane antigen, prostate neoplasms, metastatic prostate cancer, prostatic hyperplasia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A: Pre-prostatectomy patients

Arm Type

Experimental

Arm Description

Arm Title

Cohort B: Metastatic prostate cancer

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

CTT1057

Intervention Description

Single IV dose (370 MBq, or 10 mCi) of CTT1057 followed by combined PET/MR imaging (prostate + whole body).

Intervention Type

Procedure

Intervention Name(s)

Prostatectomy

Intervention Description

Radical prostatectomy with lymph node dissection

Primary Outcome Measure Information:

Title

Adverse event frequency as graded by Common Toxicity Criteria version 4.03

Time Frame

7 days from time of injection

Secondary Outcome Measure Information:

Title

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

Title

Pharmacokinetic profile of CTT1057 as measured by radiotracer detection in blood samples

Time Frame

Up to four hours from time of injection

Title

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

Title

Optimal Standardized Uptake Value (SUV) ratio threshold on CTT1057 PET/MR for discriminating tumor pathology from primary prostate cancer tissue

Time Frame

4 hours

Title

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

Title

Number of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans

Time Frame

4 hours

Title

Location of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans

Time Frame

4 hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beatrice Langton-Webster, PhD

Organizational Affiliation

Cancer Targeted Technology

Official's Role

Study Chair

Facility Information:

Facility Name

University of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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