Prostate cancer
Conditions
Interventions
Product Name: OTL78
Product Code: OTL78
Pharmaceutical Form: Infusion
INN or Proposed INN: OTL0078
Current Sponsor code: OTL0078
Sponsors
OnTarget Laboratories
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy volunteers 1) Male and 18-65 years old at screening. 2) Able and willing to comply with study procedures, with signed and dated informed consent obtained before any study-related procedure is performed. 3) Agree to use an effective method of contraception for 90 days after administration. 4) A body mass index is =30 kg/m2. 5) The subject is healthy with no acute or chronic medical illnesses, has a normal physical examination, and normal vital signs findings at screening. 6) The subject’s screening 12-lead ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered clinically insignificant at the discretion of the Investigator 7) Negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus. 8) Negative test results for drug and alcohol screening. 9) Absence of any psychological, familial, sociological or geographical condition that at the discretion of the investigator could potentially hamper compliance with the study protocol and follow-up schedule; such conditions should be discussed with the patient during the prescreening period. Patients 1) Male patients > 18 years of age and older at screening 2) Able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedures are performed. 3) Known or high clinical suspicion of primary prostate cancer (Gleason score 7+) planned for a prostatectomy 4) Known or high clinical suspicion of prostate cancer scheduled to undergo a pelvic lymph node dissection 5) The 12-lead ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered clinically insignificant at the discretion of the investigator 6) Absence of any psychological, familial, sociological or geographical condition that at the discretion of the investigator could potentially hamper compliance with the study protocol and follow-up schedule; such conditions should be discussed with the patient during the prescreening period. 7) Chronic or acute medical illness that in the discretion of the investigator may confound or complicate the findings in this study 8) Patients are clinically fit for surgery 9) Agree to use an effective method of contraception for 90 days after administration 10) Absence of any psychological, familial, sociological or geographical condition that at the discretion of the investigator could potentially hamper compliance with the study protocol and follow-up schedule; such conditions should be discussed with the patient during the prescreening period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: Healthy volunteers 1) Female subjects 2) Known acute or chronic disease, abnormal physical examination or blood tests 3) The subject has previously been included in an OTL study. 4) Use of prescription drugs within 30 days of screening and during study participation 5) Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year. 6) History of clinically significant allergies or anaphylactic reactions. 7) History of allergy to any of the components of OTL78 or excipients (see Section 3.2 IB). Patients 1) Any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient 2) History of clinically significant allergies or anaphylactic reactions. 3) History of allergy to any of the components of OTL78 or excipients (see Section 3.2 IB) 4) Impaired renal function defined as eGFR<50 ml/min/1.73m2 5) Impaired liver function defined as values greater than 3x the upper limit of normal (ULN) for ALT, AST, or 2x the upper limit of normal for total bilirubin (unless due to Gilbert Syndrome) 6) Previous participation in an OTL study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the safety and tolerability of a single IV dosage of OTL78 ; Secondary Objective: Concordance between fluorescent signal and tumor status of resected tissue (PSA and PSAP and AMACR staining on tissue sections according to standard pathology protocol and assessment). • To assess the pharmacokinetics of a single IV dose of OTL78 • To estimate the Sensitivity (or True Positive rate, TP/TP+FN) of OTL78 for detection of tissues expressing PSMA during near infrared imaging (NIR) • To estimate the Sensitivity (or True Positive rate, TP/TP+FN) of OTL78 for detection of prostate cancer cells during near infrared imaging (NIR) • To estimate the False Positive rate (FP/FP+TP) of OTL78 for detection of tissues expressing PSMA during near infrared imaging (NIR) • To estimate the False Positive rate (FP/FP+TP) of OTL78 for detection of prostate cancer cells during near infrared imaging (NIR) • To evaluate the tumor to background ratio (TBR) ; Primary end point(s): - To assess the safety and tolerability of a single IV dosage of OTL78 - To assess the pharmacokinetics of a single IV dosage of OTL78 ; Timepoint(s) of evaluation of this end point: Safety = at the end of each cohort Pharmacokinetics = at the end of each cohort | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Concordance between fluorescent signal and tumor status of resected tissue (PSA and PSAP and AMACR staining on tissue sections according to standard pathology protocol and assessment). • To assess the pharmacokinetics of a single IV dose of OTL78 • To estimate the Sensitivity (or True Positive rate, TP/TP+FN) of OTL78 for detection of tissues expressing PSMA during near infrared imaging (NIR) • To estimate the Sensitivity (or True Positive rate, TP/TP+FN) of OTL78 for detection of prostate cancer cells during near infrared imaging (NIR) • To estimate the False Positive rate (FP/FP+TP) of OTL78 for detection of tissues expressing PSMA during near infrared imaging (NIR) • To estimate the False Positive rate (FP/FP+TP) of OTL78 for detection of prostate cancer cells during near infrared imaging (NIR) • To evaluate the tumor to background ratio (TBR) ;Timepoint(s) of evaluation of this end point: At the end of the study | — |
Countries
Netherlands
Contacts
Public ContactJ. Burggraaf
Centre for Human Drug Research
Outcome results
None listed