A phase 1a/1b/2 study to assess the safety, tolerability and pharmacokinetics of OTL78, a PSMA-targeted fluorescent agent, for the intraoperative imaging of prostate cancer
- Conditions
- Prostate cancer10038597
- Registration Number
- NL-OMON49366
- Lead Sponsor
- OnTarget Laboratories
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 39
Healthy volunteers (part A)
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 procedures are 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 (part B)
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 obtained before any study-related procedures are performed.
3) Known or high clinical suspicion of (primary or recurrent) prostate cancer
scheduled to undergo a pelvic lymph node dissection for salvage or staging at
the LUMC.
4) 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
5) Chronic or acute medical illness that in the discretion of the investigator
may confound or complicate the findings in this study
6) Patients are clinically fit for surgery
7) Agree to use an effective method of contraception for 90 days after
administration
8) Absence of 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 (part C)
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 obtained before any study-related procedures are performed.
3) Known or high clinical suspicion of prostate cancer (Gleason score 7+)
planned for a prostatectomy at the NKI.
4) 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
5) Chronic or acute medical illness that in the discretion of the investigator
may confound or complicate the findings in this study
Protocol Version 1.5 / 17-Jan-2020 Page 22 of 68
6) Patients are clinically fit for surgery
7) Agree to use an effective method of contraception for 90 days after
administration
8) Absence of psychological familial, sociological or geographical condition
that at the discretion o
Healthy volunteers (part A)
1) Female subjects
2) Known acute or chronic disease, abnormal physical examination or blood tests
of clinical significance.
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
Investigator*s Brochure).
Patients (part B)
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
Investigator*s Brochure)
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
(excl. Gilbert*s syndrome)
6) Previous participation in an OTL study
Patients (part C)
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
Investigator*s Brochure)
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
(excl. Gilbert*s syndrome)
6) Previous participation in an OTL study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part A: healthy volunteers (n= up to 15)<br /><br>Primary/safety objective:<br /><br>- To assess the safety, tolerability and pharmacokinetics of a single IV<br /><br>dose of OTL78<br /><br><br /><br>Part B/part C: patients (n=24)<br /><br>Primary/safety objective:<br /><br>- To assess the safety, tolerability and pharmacokinetics of a single IV dose<br /><br>of OTL78 </p><br>
- Secondary Outcome Measures
Name Time Method