Prostate CancerPhase 1NCT02552394
J591 in Patients With Advanced Prostate Cancer and Unfavorable Circulating Tumor Cell Counts
A Phase 1 study testing huJ591 in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This clinical trial is for men with advanced prostate cancer that may have spread to other parts of the body. Currently, once prostate cancer cells have spread from the prostate to other organs it is not treatable by surgery. The purpose of this study is to treat patients with an experimental antibody (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- huJ591
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 3 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic/Cytologic diagnosis of prostate carcinoma
- Subject must have progressive metastatic prostate cancer as defined as at least any one of the following:
- New lesions on bone scan
- Progression of disease on CT/MRI as defined by RECIST
- PSA progression defined by an absolute value 2 ng/mL with an increase in PSA determined by two separate measurements taken at least one week apart and confirmed by a third, and if necessary, a fourth measurement. If the third measurement is not greater than the second measurement, then a fourth measurement must be taken; the fourth measurement must be greater than the second measurement for the subject to be eligible for enrollment in the study. Furthermore, the confirmatory PSA measurement (i.e., the third or, if applicable, fourth PSA measurement) must be 2 ng/mL and ≥ 25% above the previous nadir.
- Increase in circulating tumor cell (CTC) count via CellSearch methodology in the absence of responding tumor by other criteria.
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- Subjects must remain on a stable hormonal therapy regimen.
- Subjects who have received traditional anti-androgen (i.e. bicalutamide, nilutamide, flutamide) therapy with a resulting PSA decline must continue anti-androgen therapy or demonstrate progression following discontinuation of anti-androgen therapy (not necessary for those who never responded to anti-androgen addition).
- Medical or surgical castration will be continued for the duration of the trial in all subjects.
- Subjects who have any measure of progression on androgen receptor signaling inhibitors (such as enzalutamide or apalutamide) or CYP17 inhibitors (such as abiraterone acetate) and wish to continue must remain on a stable regimen.
- CTCs ≥ 5 per 7.5ml of whole blood performed by CellSearch system within 1 month of enrollment (may be performed as part of screening).
- Subjects capable of fathering children must agree to use an effective method of contraception for the duration of the trial.
Who cannot join
- Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment
- AST or ALT > 2.5x ULN unless secondary to liver metastasis (then AST/ALT > 5x ULN is exclusionary provided subject meets bilirubin requirements)
- Bilirubin (total) > 1.5x ULN; subjects with known Gilbert's syndrome are eligible if direct bilirubin is within normal limits
- Serum Creatinine > 3x ULN
- Absolute Neutrophil Count <1000/µL
- Hemoglobin <8 g/dL
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- Platelet Count <50,000/µL
- ECOG Performance Status >2
- Life expectancy < 6 months
- Any serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which in the investigator's opinion might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study
- Prior investigational therapy (medications or devices) within 4 weeks of treatment. Furthermore, other investigational anti-cancer therapy is not permitted during the treatment phase.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody J591 in Patients With Advanced Prostate Cancer and Unfavorable Circulating Tumor Cell Counts
This clinical trial is for men with advanced prostate cancer that may have spread to other parts of the body.
Currently, once prostate cancer cells have spread from the prostate to other organs it is not treatable by surgery. The purpose of this study is to treat patients with an experimental antibody (i.e. that has not been FDA approved) called J591 that attaches itself to a special protein on cancer cells called PSMA to try to eliminate these cancer cells (called circulating tumor cells) from the circulation.
Read more
In the initial phase of the study, 6 participants will receive the experimental J591 treatment. Routine blood tests, research blood tests, physical exam will be performed at each visit. Participants will also be asked to complete a questionnaire about how they are feeling. Participants will have a radiographic scan every 3 months to check the status of their disease.
Participants who tolerate the treatment well may be re-treated at the same level every 3 months, and may continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.
Read the detailed description
J591 is a de-immunized monoclonal antibody against the extracellular domain of prostate-specific membrane antigen (PSMA). Background data demonstrate that mAb Hu-J591 doses as low as 20 mg may lead to a decrease in CTCs and that doses up to 300 mg are safe. With a goal of establishing less frequent, potentially more convenient and cost-effective future therapy, the investigators propose a single-center, open-label, dose de-escalation study to determine the effect of mAb Hu-J591 on circulating tumor cells in subjects with metastatic PC. Four dose levels are planned with a minimum of 6 and maximum of 24 subject enrollment starting with a single infusion of 300 mg of mAb Hu-J591.
In the initial phase of the study a cohort of 6 subjects will receive 300 mg of mAb Hu-J591 and blood samples will be collected pre and post-infusion for the detection of CTCs, PSA and to assess hematological toxicity at screening, baseline, week 1, week 4, week 8, and week 12. In addition, patients will receive a dose of 89Zr-DFO-huJ591 (5 mCi) 2-4 weeks prior to treatment and will undergo 89Zr-DFO-huJ591 PET imaging 1-3 weeks pre-treatment (optional) as well as repeat 89Zr-DFO-huJ591 infusion (5 mCi) at 11 weeks and PET/CT imaging at 12 weeks (optional).
If less than four subjects respond by dropping their CTC counts from more than or equal to 5 CTCs/7.5 mL whole blood to less than 5 CTCs/7.5 mL whole blood in the initial cohort, the trial will be ended at this dose. If four or more subjects respond, an additional 6 subjects will be accrued to the second dose level (200 mg). The same decision rule will be applied to evaluate two additional lower dose levels (100 mg, 50 mg) with 6 subjects enrolled in each cohort. Imaging studies will be performed prior to treatment at screening and at 3 months or as clinically indicated to assess disease response.
Subjects who tolerate the initial infusion well (< grade 2 toxicities) may be re-treated every 3 months (12 weeks) at the same dose-level until progression.
- Conditions
- Prostate Cancer
- Being tested
- huJ591
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
huJ591Drug
Also called J591
HuJ591 will be administered as an intravenous infusion at a concentration of 5 mg/mL and rate of <5 mg/minute. Pre-medications prior to J591 infusion with diphenhydramine 25 - 50 mg p.o. or IV and acetaminophen 500 - 650 mg p.o.
| Study group | Role | What they receive |
|---|---|---|
| HuJ591 Administration | Experimental | 6 subjects will be treated at 300 mg dose. The decision about treating subjects at the lower dose will depend upon their response. If ≥4 of 6 subjects respond at the 300 mg level, then 6 more subjects will be recruited at the 200 mg level. If ≥4 of 6 subjects respond at the 200 mg level than 6 more subjects will be recruited at the next dose level of 100 mg. If ≥ 4/6 subjects respond at this level, then 6 subjects will be recruited at the last dose level of 50 mg. At any level, if the first four consecutive subjects respond, the next two subjects will be enrolled in the same dose-level cohort and further subjects will be recruited at the next dose level. Response at every dose level is defined by conversion from an unfavorable CTC count at baseline to a favorable CTC count. Receives: Drug: huJ591 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in frequency of achieving a decrease in Circulating tumor count (CTC)
Determine the effect of mAb Hu-J591 on reducing circulating tumor cells (CTCs) from > 5/7.5 mL of whole blood to < 5/7.5 mL of whole blood in metastatic prostate cancer (PC) with elevated baseline CTC count and to identify the least effective dose that clears CTCs.
Measured: CTCs will be measured on Day 1, Day 8, Day 29, Day 57, and Day 85, then monthly until the date of first documented progression, or death from any cause, whichever came first assessed up to 100 months
Secondary outcomes (3)
Changes in prostate specific antigen (PSA) measurable disease response
Dose cohort will report the proportion of subjects achieving declines of ≥ 30% confirmed by a second PSA value ≥ 2 weeks later. In addition, for subjects with measureable disease at baseline, the frequency of achieving an objective response as described by Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) will be presented by dose cohort. The distributions of the duration of both of these clinical outcomes will be presented by dose level.
Measured: Response will be measured by performing CT scans every 3 months from baseline until the date of first documented progression, or death from any cause, whichever came first assessed up to 100 months
Change in duration of Circulating tumor count (CTC) response
Descriptive statistics (e.g. means, proportions, medians, range) will be calculated to summarize the baseline CTC values and the change at 12 weeks and presented by dose level. This will include calculating the frequency of CTC responders, the proportion of responders, the percent change in CTC count, the duration of CTC count remaining <5/7.5mL if it occurs, the duration of time to first measurement of CTC count <5/7.5mL.
Measured: Labs will be collected at Screening, Day 1, Day 8, Day 29, Day 57 and Day 85
Change in disease response through the optional (but recommended) prostate specific membrane antigen (PSMA) PET/CT imaging
Measurable disease response will be calculated using Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) with Prostate Cancer Clinical Trials Working Group 3 (PCWG3) modifications.
Measured: Performed prior to treatment at screening and at 3 months/12 weeks or as clinically indicated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startJul 2015
- Primary completion14 Nov 2019
- Study completion3 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Tagawa, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552394
- Sponsor's protocol ID
- 1503015998
- Status last verified
- Apr 2023
- First submitted
- 3 Aug 2015
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody J591 in Patients With Advanced Prostate Cancer and Unfavorable Circulating Tumor Cell Counts
- ClinicalTrials.gov ID
- NCT02552394
- Acronym / sponsor ID
- 1503015998
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 3 Jan 2021 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is for men with advanced prostate cancer that may have spread to other parts of the body.
Currently, once prostate cancer cells have spread from the prostate to other organs it is not treatable by surgery. The purpose of this study is to treat patients with an experimental antibody (i.e. that has not been FDA approved) called J591 that attaches itself to a special protein on cancer cells called PSMA to try to eliminate these cancer cells (called circulating tumor cells) from the circulation.
In the initial phase of the study, 6 participants will receive the experimental J591 treatment. Routine blood tests, research blood tests, physical exam will be performed at each visit. Participants will also be asked to complete a questionnaire about how they are feeling. Participants will have a radiographic scan every 3 months to check the status of their disease.
Participants who tolerate the treatment well may be re-treated at the same level every 3 months, and may continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.
Detailed description
J591 is a de-immunized monoclonal antibody against the extracellular domain of prostate-specific membrane antigen (PSMA). Background data demonstrate that mAb Hu-J591 doses as low as 20 mg may lead to a decrease in CTCs and that doses up to 300 mg are safe. With a goal of establishing less frequent, potentially more convenient and cost-effective future therapy, the investigators propose a single-center, open-label, dose de-escalation study to determine the effect of mAb Hu-J591 on circulating tumor cells in subjects with metastatic PC. Four dose levels are planned with a minimum of 6 and maximum of 24 subject enrollment starting with a single infusion of 300 mg of mAb Hu-J591.
In the initial phase of the study a cohort of 6 subjects will receive 300 mg of mAb Hu-J591 and blood samples will be collected pre and post-infusion for the detection of CTCs, PSA and to assess hematological toxicity at screening, baseline, week 1, week 4, week 8, and week 12. In addition, patients will receive a dose of 89Zr-DFO-huJ591 (5 mCi) 2-4 weeks prior to treatment and will undergo 89Zr-DFO-huJ591 PET imaging 1-3 weeks pre-treatment (optional) as well as repeat 89Zr-DFO-huJ591 infusion (5 mCi) at 11 weeks and PET/CT imaging at 12 weeks (optional).
If less than four subjects respond by dropping their CTC counts from more than or equal to 5 CTCs/7.5 mL whole blood to less than 5 CTCs/7.5 mL whole blood in the initial cohort, the trial will be ended at this dose. If four or more subjects respond, an additional 6 subjects will be accrued to the second dose level (200 mg). The same decision rule will be applied to evaluate two additional lower dose levels (100 mg, 50 mg) with 6 subjects enrolled in each cohort. Imaging studies will be performed prior to treatment at screening and at 3 months or as clinically indicated to assess disease response.
Subjects who tolerate the initial infusion well (< grade 2 toxicities) may be re-treated every 3 months (12 weeks) at the same dose-level until progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HuJ591 Administration | Experimental | Drug: huJ5916 subjects will be treated at 300 mg dose. The decision about treating subjects at the lower dose will depend upon their response. If ≥4 of 6 subjects respond at the 300 mg level, then 6 more subjects will be recruited at the 200 mg level. If ≥4 of 6 subjects respond at the 200 mg level than 6 more subjects will be recruited at the next dose level of 100 mg. If ≥ 4/6 subjects respond at this level, then 6 subjects will be recruited at the last dose level of 50 mg. At any level, if the first four consecutive subjects respond, the next two subjects will be enrolled in the same dose-level cohort and further subjects will be recruited at the next dose level. Response at every dose level is defined by conversion from an unfavorable CTC count at baseline to a favorable CTC count. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologic/Cytologic diagnosis of prostate carcinoma
- Subject must have progressive metastatic prostate cancer as defined as at least any one of the following:
- Subjects must remain on a stable hormonal therapy regimen.
- CTCs ≥ 5 per 7.5ml of whole blood performed by CellSearch system within 1 month of enrollment (may be performed as part of screening).
- Subjects capable of fathering children must agree to use an effective method of contraception for the duration of the trial.
Key exclusion criteria (11 listed)
- Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment
- AST or ALT > 2.5x ULN unless secondary to liver metastasis (then AST/ALT > 5x ULN is exclusionary provided subject meets bilirubin requirements)
- Bilirubin (total) > 1.5x ULN; subjects with known Gilbert's syndrome are eligible if direct bilirubin is within normal limits
- Serum Creatinine > 3x ULN
- Absolute Neutrophil Count <1000/µL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| huJ591Also: J591HuJ591 will be administered as an intravenous infusion at a concentration of 5 mg/mL and rate of <5 mg/minute. Pre-medications prior to J591 infusion with diphenhydramine 25 - 50 mg p.o. or IV and acetaminophen 500 - 650 mg p.o. | Drug | HuJ591 Administration |
Primary outcome
Changes in frequency of achieving a decrease in Circulating tumor count (CTC)
Time frame: CTCs will be measured on Day 1, Day 8, Day 29, Day 57, and Day 85, then monthly until the date of first documented progression, or death from any cause, whichever came first assessed up to 100 months
Determine the effect of mAb Hu-J591 on reducing circulating tumor cells (CTCs) from > 5/7.5 mL of whole blood to < 5/7.5 mL of whole blood in metastatic prostate cancer (PC) with elevated baseline CTC count and to identify the least effective dose that clears CTCs.
3 secondary outcomes
Changes in prostate specific antigen (PSA) measurable disease response
Time frame: Response will be measured by performing CT scans every 3 months from baseline until the date of first documented progression, or death from any cause, whichever came first assessed up to 100 months
Change in duration of Circulating tumor count (CTC) response
Time frame: Labs will be collected at Screening, Day 1, Day 8, Day 29, Day 57 and Day 85
Change in disease response through the optional (but recommended) prostate specific membrane antigen (PSMA) PET/CT imaging
Time frame: Performed prior to treatment at screening and at 3 months/12 weeks or as clinically indicated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Tagawa, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing huJ591 in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in frequency of achieving a decrease in Circulating tumor count (CTC) (time frame: CTCs will be measured on Day 1, Day 8, Day 29, Day 57, and Day 85, then monthly until the date of first documented progression, or death from any cause, whichever came first assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.