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CompletedNCT03315754Updated Sep 10, 2026Results posted

Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer.

A Phase 2 interventional study of TOOKAD Soluble 4 mg/kg in Localized Prostate Cancer, sponsored by Steba Biotech S.A.. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Steba Biotech S.A. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

Single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial. Men with localized prostate cancer will receive TOOKAD® Soluble VTP under general anesthesia.

To evaluate the absence of biopsy detectable Gleason grade 4 or 5 prostate cancer tumors anywhere in the prostate gland on 12-month, post-treatment biopsy following TOOKAD® Soluble-VTP in men with prostate cancer Gleason score 7(3+4).

Read the detailed description

This is a single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial. The primary objective of the study is to evaluate the absence of biopsy detectable Gleason grade 4 or 5 prostate cancer tumors anywhere in the prostate gland on 12-month, post-treatment biopsy following TOOKAD® Soluble-VTP. Men with Gleason score 7 (3+4) prostate cancer on one half of the prostate will receive TOOKAD® Soluble VTP under general anesthesia. Treatment will consist in hemiablation procedure designed to destroy the lobe of the prostate gland that contains the Gleason score 7 (3+4) cancer. Afterwards, patients will be followed for 5 years (60 months) with clinical evaluation, questionnaires on QOL, erectile and urinary functions, and PSA testing. In addition, treatment outcomes will be assessed based on prostate biopsy results at 3, 12, 24, 36, 48 and 60 months after the TOOKAD® Soluble treatment. All patients will undergo biopsy at 3 and 12 months. If the Month 3 biopsy is positive for any cancer, patients will be allowed a single re-treatment by TOOKAD® Soluble VTP to one or both lobes.

02

Conditions studied

  • Localized Prostate Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. Men over 18 years of age.
  2. Patients who have had a multiparametric MRI of the prostate performed and have undergone transrectal systematic biopsy plus biopsy of any volumes considered suspicious per the MRI (PIRADS version 2 score of 4 or 5) within 6 months before signing consent.
  3. Histologic diagnosis of prostate cancer identifying Gleason score of 3+4 on one half of the prostate gland in no more than 2 sextants of the prostate gland and not present in more than 50% of any one core taken systematically. The involvement criterion does not apply to cores taken from MRI suspicious volumes.
  4. Patients with concomitant Gleason score 3+3 prostate cancer in less than 50% of any core at any site will be considered eligible.
  5. Prostate cancer stage up to cT2a - N0/Nx - M0/Mx.
  6. Prostate volume ≥25 mL and ≤70 mL.
  7. Serum PSA ≤10 ng/mL.
  8. Men who are sexually active with women of childbearing potential must use contraceptive method with a failure rate of less than 1% per year. Contraception should be continued for a period of 90 days after the VTP procedure. The individual methods of contraception may be determined in consultation
  9. Signed Informed Consent Form.

Exclusion criteria

Exclusion Criteria:

  1. Unwillingness to accept the treatment;
  2. Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy;
  3. Any surgical intervention for benign prostatic hypertrophy;
  4. Any condition or history of illness or surgery that might pose an additional risk to men undergoing the VTP procedure;
  5. Life expectancy less than 10 years;
  6. Participation in another clinical study involving an investigational product within 1 month before study entry;
  7. Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks, especially inability to understand and fulfill the health-related QOL questionnaire;
  8. Subjects in custody and or residing in a nursing home or rehabilitation facility;
  9. Biopsy proven locally advanced or metastatic prostate cancer.
  10. Any condition or history of illness or surgery that in the opinion of the investigator might affect the conduct and results of the study or pose additional risks to the subject (e.g., cardiac or respiratory disease precluding general anesthesia; anticoagulant treatment which cannot be temporarily withdrawn for the procedure).
  11. Medical conditions that preclude the use of general anesthesia;
  12. Any condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of fistula formation;
  13. Hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production within the previous 6 months;
  14. History of urethral stricture disease;
  15. History of acute urinary retention within 6 months of study entry;
  16. Condition requiring medication with potential photosensitizing effects (tetracyclines, quinolones, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin, and amiodarone) if these treatments could not be stopped at least 10 days before and for 3 days after the VTP procedure or replaced by treatments without photosensitizing properties;
  17. Anticoagulant drugs (e.g., warfarin) that could not be withdrawn during the 10 days prior to the VTP procedure or antiplatelet drugs (e.g. aspirin) that could not be withdrawn during the 10 days prior to the VTP procedure and 3 days after VTP;
  18. Renal and hepatic disorders with values of >1.5 times the upper limit of normal (ULN) or blood disorders (upon clinician judgment);
  19. A history of sun hypersensitivity or photosensitive dermatitis.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    TOOKAD Soluble 4 mg/kg

    TOOKAD® Soluble VTP treatment consist of the combination of a single, 10-minute IV infusion of TOOKAD® Soluble at the dose of 4 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds.

    Drug: TOOKAD Soluble 4 mg/kg

Interventions

  • DrugTOOKAD Soluble 4 mg/kg

    Vascular targeted photodynamic therapy using TOOKAD Soluble

    Also known as: WST11

05

What researchers measure

Primary outcomes

  1. Participants With Negative Biopsy for Gleason Score 7 (Gleason Grade 4 or 5) Prostate Cancer on 12-month Post-treatment

    This outcome reports the percent of participants with response to treatment defined as absence of high-grade cancer (Gleason score 7 (Gleason grade 4 or 5) on bilateral biopsy at 12-month post VTP treatment. The Gleason grading system is a histopathological scale used to evaluate the aggressiveness of prostate cancer. The Gleason score is determined by summing the two most predominant histological patterns observed in tumor tissue, each graded on a scale from 1 (well-differentiated) to 5 (poorly differentiated). The total Gleason score ranges from 2 to 10, with higher scores indicating more aggressive disease. PP (per protocol) is all participants who met all key eligibility criteria at baseline and did not have any major deviations that could invalidate eligibility or the integrity/timing of the 12-month biopsy (biopsy missing/out of window, or pre-12-month salvage therapy). ITT( intent-to treat) is all patients who undergo VTP procedure, regardless of protocol deviations

    Time frame: 12 months

Secondary outcomes

  1. Absence of Gleason Score 7 ( Gleason Grade 4 or 5) in Entire Prostate

    Binary response to treatment defined as the absence of Gleason score 7 ( Gleason grade 4 or 5 ) biopsy at or before months 3, 12, 24, 36, 48 and 60. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of Gleason grade 4 or 5, the subject will be considered to have responded.

    Time frame: 3, 12, 24,36,48, 60 months

  2. Absence of Any Prostate Cancer on Biopsy

    Binary response to treatment defined as the absence of any prostate cancer on biopsy on or before months 3, 12, 24, 36 and 60. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of any cancer, the subject will be considered to have responded

    Time frame: months 3, 12, 24, 36, 48 and 60

  3. Absence of Gleason Score 7 (Gleason Grade 4 or 5) in the Treated Lobe

    Binary response to treatment defined as the absence of Gleason score 7 (Gleason grade 4 or 5) biopsy at or before months 3,12, 24, 36, 48 and 60 in the treated lobe. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of Gleason grade 4 or 5, the subject will be considered to have responded;

    Time frame: months 3,12, 24, 36, 48 and 60

  4. Absence of Any Prostate Cancer on Biopsy in the Treated Lobe

    Binary response to treatment defined as the absence of any prostate cancer on biopsy on or before months 3, 12, 24, 36, 48 and 60 in the treated lobe. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of any cancer, the subject will be considered to have responded

    Time frame: months 3, 12, 24, 36, 48 and 60

  5. Changes in Biopsy Parameters (Gleason Score)

    Changes in biopsy parameters (Gleason score) between the baseline biopsy (Gleason score 7 (3+4) and months 3, 12, 24, 36, 48 , 60 biopsies. The Gleason grading system is a histopathological scale used to assess prostate cancer aggressiveness, with total scores ranging from 2 to 10 (sum of two predominant patterns graded 1-5). Higher scores indicate more aggressive disease. This outcome reports the proportion of participants with absence of high-grade cancer (no Gleason score \<7 (Gleason pattern \< 4 or 5) in the treated lobe at each time point

    Time frame: 3,12,24,36,48, 60 months

  6. The International Prostate Symptom Score (IPSS) Questionnaire

    The International Prostate Symptom Score (IPSS) is a 7 item questionnaire assessing lower urinary tract symptom severity. Each item is scored from 0 to 5, item scores are summed to give a total score ranging from 0 to 35. Higher scores indicate more severe symptoms and a worse outcome. Scores of 0-7 indicate mild, 8-19 moderate and 20-35 severe symptoms. Patient-reported outcome measures (PROMs) impairment: urinary symptoms using IPSS prior to treatment beginning and then 1, 3, 6, 12, 24, 36, 48 and 60 months after completing treatment

    Time frame: months 1, 3, 6, 12, 24, 36, 48 and 60

  7. International Index of Erectile Function (IIEF15) Questionnaire

    The International Index of Erectile Function (IIEF 15) is a 15 item questionnaire assessing male sexual function. Item scores are summed to obtain a total score ranging s from 5 to 75. Higher total scores indicate better sexual function and therefore a better outcome.

    Time frame: months 1, 3, 6, 12, 24, 36, 48 and 60

  8. Severe Prostate Cancer Related Events

    Severe prostate cancer-related events defined as cancer extension to T3, metastasis or prostate cancer-related death

    Time frame: up to 60 months

  9. Secondary Prostate Cancer Treatment

    Use of secondary prostate cancer treatment following VTP will include surgical removal of the prostate gland, radiation treatment to the prostate gland, use of hormone or chemotherapies

    Time frame: Up to 60 months

  10. PSA

    Serum PSA measurements in ng/mL at visit 0 (baseline) and at follow up visits at 1, 3, 6,12,24,36,48 and 60 months.

    Time frame: Months 1, 3, 6, 12, 24, 36, 48, 60

06

Results

Posted Aug 2, 2023

Participant flow

Fifty men presenting with Gleason score 7 (3+4) prostate cancer in at least one lobe were enrolled in the study.

Participant flow — Overall Study
MilestoneTOOKAD Soluble 4 mg/kg
Started50
Completed48
Not completed2
Withdrew: Covid-19 complications leading to death1
Withdrew: Insurance coverage issue1

Outcome measures

PrimaryParticipants With Negative Biopsy for Gleason Score 7 (Gleason Grade 4 or 5) Prostate Cancer on 12-month Post-treatment

This outcome reports the percent of participants with response to treatment defined as absence of high-grade cancer (Gleason score 7 (Gleason grade 4 or 5) on bilateral biopsy at 12-month post VTP treatment. The Gleason grading system is a histopathological scale used to evaluate the aggressiveness of prostate cancer. The Gleason score is determined by summing the two most predominant histological patterns observed in tumor tissue, each graded on a scale from 1 (well-differentiated) to 5 (poorly differentiated). The total Gleason score ranges from 2 to 10, with higher scores indicating more aggressive disease. PP (per protocol) is all participants who met all key eligibility criteria at baseline and did not have any major deviations that could invalidate eligibility or the integrity/timing of the 12-month biopsy (biopsy missing/out of window, or pre-12-month salvage therapy). ITT( intent-to treat) is all patients who undergo VTP procedure, regardless of protocol deviations

Time frame:
12 months
Reported as:
Count of participants · Participants
Participants With Negative Biopsy for Gleason Score 7 (Gleason Grade 4 or 5) Prostate Cancer on 12-month Post-treatment
Participants12 Months Follow up PP Group12 Months Follow up ITT Group
Participants With Negative Biopsy for Gleason Score 7 (Gleason Grade 4 or 5) Prostate Cancer on 12-month Post-treatment37 (64.9 to 92.3)38
SecondaryAbsence of Gleason Score 7 ( Gleason Grade 4 or 5) in Entire Prostate

Binary response to treatment defined as the absence of Gleason score 7 ( Gleason grade 4 or 5 ) biopsy at or before months 3, 12, 24, 36, 48 and 60. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of Gleason grade 4 or 5, the subject will be considered to have responded.

Time frame:
3, 12, 24,36,48, 60 months
Reported as:
Count of participants · Participants
Absence of Gleason Score 7 ( Gleason Grade 4 or 5) in Entire Prostate
Participants3 Months Follow up12 Months Follow up24 Months Follow up36 Months Follow up48 Months Follow up60 Months Follow up
Absence of Gleason Score 7 ( Gleason Grade 4 or 5) in Entire Prostate37 (61.9 to 83.9)38 (64 to 85.5)5 (34.1 to 94.7)5 (25.1 to 83.1)12 (56.0 to 94.3)5 (28.9 to 88.9)
SecondaryAbsence of Any Prostate Cancer on Biopsy

Binary response to treatment defined as the absence of any prostate cancer on biopsy on or before months 3, 12, 24, 36 and 60. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of any cancer, the subject will be considered to have responded

Time frame:
months 3, 12, 24, 36, 48 and 60
Reported as:
Count of participants · Participants
Absence of Any Prostate Cancer on Biopsy
Participants3 Months Follow up12 Months Follow up24 Months Follow up36 Months Follow up48 Months Follow up60 Months Follow up
Absence of Any Prostate Cancer on Biopsy22 (32 to 56.6)27 (41.5 to 66.2)4 (22.5 to 87.1)1 (0.6 to 42.9)4 (9.7 to 51.1)3 (11.1 to 71.1)
SecondaryAbsence of Gleason Score 7 (Gleason Grade 4 or 5) in the Treated Lobe

Binary response to treatment defined as the absence of Gleason score 7 (Gleason grade 4 or 5) biopsy at or before months 3,12, 24, 36, 48 and 60 in the treated lobe. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of Gleason grade 4 or 5, the subject will be considered to have responded;

Time frame:
months 3,12, 24, 36, 48 and 60
Reported as:
Count of participants · Participants
Absence of Gleason Score 7 (Gleason Grade 4 or 5) in the Treated Lobe
Participants3 Months Follow up12 Months Follow up24 Months Follow up36 Months Follow up48 Months Follow up60 Months Follow up
Absence of Gleason Score 7 (Gleason Grade 4 or 5) in the Treated Lobe39 (66.2 to 87.1)39 (66.2 to 87.1)5 (34.1 to 94.7)6 (34.5 to 90.2)13 (63.7 to 97.6)5 (28.9 to 88.9)
SecondaryAbsence of Any Prostate Cancer on Biopsy in the Treated Lobe

Binary response to treatment defined as the absence of any prostate cancer on biopsy on or before months 3, 12, 24, 36, 48 and 60 in the treated lobe. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of any cancer, the subject will be considered to have responded

Time frame:
months 3, 12, 24, 36, 48 and 60
Reported as:
Count of participants · Participants
Absence of Any Prostate Cancer on Biopsy in the Treated Lobe
Participants3 Months Follow up12 Months Follow up24 Months Follow up36 Months Follow up48 Months Follow up60 Months Follow up
Absence of Any Prostate Cancer on Biopsy in the Treated Lobe30 (47.4 to 71.7)33 (53.5 to 77.1)5 (34.1 to 94.7)4 (16.9 to 74.9)8 (30 to 75.6)5 (28.9 to 88.9)
SecondaryChanges in Biopsy Parameters (Gleason Score)

Changes in biopsy parameters (Gleason score) between the baseline biopsy (Gleason score 7 (3+4) and months 3, 12, 24, 36, 48 , 60 biopsies. The Gleason grading system is a histopathological scale used to assess prostate cancer aggressiveness, with total scores ranging from 2 to 10 (sum of two predominant patterns graded 1-5). Higher scores indicate more aggressive disease. This outcome reports the proportion of participants with absence of high-grade cancer (no Gleason score \<7 (Gleason pattern \< 4 or 5) in the treated lobe at each time point

Time frame:
3,12,24,36,48, 60 months
Reported as:
Count of participants · Participants
Changes in Biopsy Parameters (Gleason Score)
ParticipantsBiopsy Changes 3 Months Follow upBiopsy Changes 12 Months Follow upBiopsy Changes 24 Months Follow upBiopsy Changes 36 Months Follow upBiopsy Changes 48 Months Follow upBiopsy Changes 60 Months Follow up
responders with Gleason score <7393956135
non responders with Gleason score >711112323
SecondaryThe International Prostate Symptom Score (IPSS) Questionnaire

The International Prostate Symptom Score (IPSS) is a 7 item questionnaire assessing lower urinary tract symptom severity. Each item is scored from 0 to 5, item scores are summed to give a total score ranging from 0 to 35. Higher scores indicate more severe symptoms and a worse outcome. Scores of 0-7 indicate mild, 8-19 moderate and 20-35 severe symptoms. Patient-reported outcome measures (PROMs) impairment: urinary symptoms using IPSS prior to treatment beginning and then 1, 3, 6, 12, 24, 36, 48 and 60 months after completing treatment

Time frame:
months 1, 3, 6, 12, 24, 36, 48 and 60
Reported as:
Mean · scores on a scale
The International Prostate Symptom Score (IPSS) Questionnaire
scores on a scalePre Treatment Visit 01 Month Follow up3 Months Follow up6 Months Follow up12 Months Follow up24 Months Follow up36 Months Follow up48 Months Follow up60 Months Follow up
The International Prostate Symptom Score (IPSS) Questionnaire8.06 ± 5.4810.86 ± 5.296.92 ± 4.277.22 ± 4.676.6 ± 4.687.97 ± 5.578.48 ± 4.789.32 ± 5.147.97 ± 5.65
SecondaryInternational Index of Erectile Function (IIEF15) Questionnaire

The International Index of Erectile Function (IIEF 15) is a 15 item questionnaire assessing male sexual function. Item scores are summed to obtain a total score ranging s from 5 to 75. Higher total scores indicate better sexual function and therefore a better outcome.

Time frame:
months 1, 3, 6, 12, 24, 36, 48 and 60
Reported as:
Mean · scores on a scale
International Index of Erectile Function (IIEF15) Questionnaire
scores on a scaleBefore Treatment Visit 01 Months Follow up3 Months Follow up6 Months Follow up12 Months Follow up24 Months Follow up36 Months Follow up48 Months Follow up60 Months Follow up
International Index of Erectile Function (IIEF15) Questionnaire38.98 ± 16.9338.45 ± 9.2639.9 ± 10.2842.3 ± 11.7240.9 ± 13.4341.31 ± 11.3637.31 ± 8.4837.13 ± 7.5736.56 ± 8.43
SecondarySevere Prostate Cancer Related Events

Severe prostate cancer-related events defined as cancer extension to T3, metastasis or prostate cancer-related death

Time frame:
up to 60 months
Reported as:
Count of participants · Participants
Severe Prostate Cancer Related Events
ParticipantsSevere Prostate Cancer Related Events
Severe Prostate Cancer Related Events0
SecondarySecondary Prostate Cancer Treatment

Use of secondary prostate cancer treatment following VTP will include surgical removal of the prostate gland, radiation treatment to the prostate gland, use of hormone or chemotherapies

Time frame:
Up to 60 months
Reported as:
Count of participants · Participants
Secondary Prostate Cancer Treatment
ParticipantsSecondary Prostate Cancer Treatment
Prostatectomy — Prostatectomy10
prostate ablation — Prostatectomy1
cryotherapy — Prostatectomy1
SecondaryPSA

Serum PSA measurements in ng/mL at visit 0 (baseline) and at follow up visits at 1, 3, 6,12,24,36,48 and 60 months.

Time frame:
Months 1, 3, 6, 12, 24, 36, 48, 60
Reported as:
Mean · ng/ml
PSA
ng/mlBaseline Visit 01 Month Follow up3 Months Follow up6 Months Follow up12 Months Follow up24 Months Follow up36 Months Follow up48 Months Follow up60 Months Follow up
PSA5.8 ± 2.04.69 ± 7.52.4 ± 1.552.5 ± 1.62.3 ± 1.52.4 ± 1.452.7 ± 2.02.9 ± 2.23.5 ± 2.8

Adverse events

Collected over 60 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
VTP Using TOOKAD Soluble1/50 (2%)9/50 (18%)50/50 (100%)
Most frequent serious events
Most frequent serious events
EventVTP Using TOOKAD Soluble
Total knee replacementSurgical and medical procedures2/9
NauseaGastrointestinal disorders1/9
VomitingGastrointestinal disorders1/9
ConstipationGastrointestinal disorders1/9
ChillsGeneral disorders1/9
COVID-19Infections and infestations1/9
Flank painMusculoskeletal and connective tissue disorders1/9
DizzinessNervous system disorders1/9
Most frequent other events
Showing 10 of 38
Most frequent other events
EventVTP Using TOOKAD Soluble
Micturition urgencyRenal and urinary disorders39/50
PollakiuriaRenal and urinary disorders39/50
HematuriaRenal and urinary disorders33/50
Urinary tract painRenal and urinary disorders31/50
Erectile dysfunctionReproductive system and breast disorders28/50
ConstipationGastrointestinal disorders23/50
PainGeneral disorders17/50
HaematospermiaReproductive system and breast disorders15/50
Infections and infestationsInfections and infestations12/50
Urinary incontinenceRenal and urinary disorders12/50

Baseline characteristics

Age, Customized
Age, Customized(years)TOOKAD Soluble 4 mg/kg
Age61.9 ± 5.8
Sex: Female, Male
Sex: Female, Male(Participants)TOOKAD Soluble 4 mg/kg
Female0
Male50
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)TOOKAD Soluble 4 mg/kg
Race, (%) — Unknown/Not Reported8
Race, (%) — White39
Race, (%) — African American1
Race, (%) — Asian1
Race, (%) — American Indian/Alaska Native1
Region of Enrollment
Region of Enrollment(Participants)TOOKAD Soluble 4 mg/kg
United States50
Number of Participants with Biopsy for Gleason score 7 (3+4) prostate cancer in at least one lobe
Number of Participants with Biopsy for Gleason score 7 (3+4) prostate cancer in at least one lobe(Participants)TOOKAD Soluble 4 mg/kg
Count of participants50
07

Study locations

1 site
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10021, United States
08

References and documents

Study documents

  • Study protocol · Sep 29, 2023
  • Statistical analysis plan · Jan 4, 2021

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03315754
Lead sponsor
Steba Biotech S.A.
Responsible party
Sponsor
First posted
Oct 20, 2017
Start date
Oct 2, 2017
Primary completion
Nov 2, 2020
Completion
Dec 31, 2024
Results posted
Aug 2, 2023
Last update
Sep 10, 2026

Study contacts

Jonathan Coleman, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
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