Solid TumorsPhase 1/2NCT02661542

Study of FF-10502-01 in Patients With Advanced Solid Tumors and Lymphomas

A Phase 1/2 study testing FF-10502-01 in people with Solid Tumors and Lymphomas, run by Fujifilm Pharmaceuticals U.S.A., Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Phase 1/2a, dose-escalation study of FF-10502-01 in Patients with Advanced Solid Tumors and Lymphomas. A total of up to 9 cohorts will be enrolled in Phase 1 to establish the Maximum Tolerated Dose (MTD). Phase 2 will consist of 2 cohorts: Cohort 1 will include subjects with Pancreatic Cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors, Lymphomas
What is being tested?: FF-10502-01
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 2 sitesUnited States
Study dates: Jan 2016to 5 Nov 2020
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females ≥ 18 years of age
Histologically or cytologically confirmed advanced or metastatic solid tumor or l lymphoma, that is refractory to standard therapy, relapsed after standard therapy, or for which no standard therapy available that is expected to improve survival by at least three months
At least 4 weeks beyond the last chemotherapy (or ≥ 5 half-lives for targeted agents, whichever is shorter), radiotherapy, major surgery or experimental treatment and recovered from all acute toxicities (≤ Grade 1)
Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2
Life expectancy of ≥ 3 months
Adequate hematologic parameters without ongoing transfusional support:

Show all 16Show fewer

Hemoglobin (Hb) ≥ 9 g/dL
Absolute neutrophil count (ANC) ≥ 1.0 x 109 cells/L
Platelets ≥ 100 x 109 cells/L
Adequate renal and hepatic function:
Creatinine ≤ 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 mL/minute x 1.73 m2 per the Cockcroft-Gault formula
Total bilirubin ≤ 2 times the upper limit of normal (ULN) unless due to Gilbert's disease
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ( ≤ 2.5 times ULN, or < 5 times ULN for subjects with liver metastases
QT interval corrected for rate (QTc) ≤ 480 msec on the electrocardiogram (ECG) obtained at Screening
Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 28 days after the completion of study treatment.
Ability to provide written informed consent

Who cannot join

Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV
Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care
Active central nervous system (CNS) malignant disease in subjects with a history of CNS malignancy. Subjects with stable, prior or currently treated brain metastases are allowed.
Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
Active infection requiring intravenous (IV) antibiotic usage within the last week prior to study treatment
Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results
Pregnant or breast-feeding

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Sarah Cannon Research Institute at HealthOne
Denver, Colorado, 80218
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase 1/2a, Dose-escalation Study of FF-10502-01 for the Treatment of Advanced Solid Tumors and Lymphomas

Read the detailed description

Subjects will receive doses of FF-10502-01 intravenously (IV) weekly for three weeks, repeated every 28 days (= 1 cycle). Disease assessments, based on computed tomography (CT), magnetic resonance image (MRI), and, for lymphoma, [18F]-fluorodeoxyglucose positron emission tomography (FDG-PET) scans, will be obtained at Week 8 and every 8 weeks thereafter until documented progression of disease (PD). Subjects who demonstrate clinical benefit will be allowed to continue therapy with FF-10502-01 until progression of disease, observation of unacceptable adverse events, intercurrent illness or changes in the subject's condition that prevents further study participation.

Conditions: Solid Tumors, Lymphomas
Being tested: FF-10502-01
Medical subject headings: Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FF-10502-01Drug

Study groups in NCT02661542
Study group	Role	What they receive
Phase 1, Cohorts 1-9	Experimental	FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing by cohort: Cohort 1, 8mg/m2; Cohort 2, 12mg/m2; Cohort 3, 18mg/m2, Cohort 4, 27mg/m2; Cohort 5, 40mg/m2; Cohort 6, 60mg/m2; Cohort 7, 90mg/m2; Cohort 8, 135mg/m2; Cohort 9, 100mg/m2. Receives: Drug: FF-10502-01
Phase 2a, Cohort 10, Advanced solid tumors	Experimental	FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. Receives: Drug: FF-10502-01
Phase 2a, Cohort 11, Cholangiocarcinoma	Experimental	FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. Receives: Drug: FF-10502-01
Phase 2a, Cohort 12, Gall bladder carcinoma	Experimental	FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. Receives: Drug: FF-10502-01
Phase 2a, Cohort 13, Urothelial carcinoma	Experimental	FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. Receives: Drug: FF-10502-01

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Safety and tolerability assessed by number of subjects with adverse events (AEs), and serious adverse events. (SAEs)
Measured: Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.

Secondary outcomes (9)

Number of Subjects With Overall Response Rates (ORR)
Number of subjects who had overall responses of Partial Response, Stable Disease, Progressive Disease or Not Evaluable
Measured: Responses assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug (every 28 days=1 cycle), up to 38 months
Number of Subjects With Objective Response (OR) Events
Number of subjects with objective response events, number of subjects with progressive disease or death events atter objective response and number of subjects censored after objective response
Measured: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Objective Response (OR)
Median duration of objective response in days for each cohort".
Measured: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Stable Disease (SD) Events
Number of subjects with stable disease, number of subjects with progressive disease or death after stable disease and number of subjects censored after stable disease
Measured: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Stable Disease (SD)
Median duration of stable disease (SD) in days for each cohort
Measured: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Progression-free Survival (PFS) Events
Number of subjects with progressive disease or death and number of subject censored.
Measured: Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Progression-free Survival (PFS)
This outcome measure shows the median number of days of progression-free survival (PFS) for each cohort
Measured: Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Overall Survival (OS) Events
Number of subjects with overall survival (OS) events in each cohort
Measured: Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Overall Survival (OS)
Median number of days of overall survival (OS) for each cohort
Measured: Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 20165 Nov 2020

First posted22 Jan 2016 (estimated)
Study startJan 2016
Primary completion5 Nov 2020
Study completion5 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Solid TumorsStudies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02661542
Sponsor's protocol ID: FF1050201US101
Status last verified: Apr 2026
First submitted: 13 Jan 2016
Last updated: 23 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2a, Dose-escalation Study of FF-10502-01 for the Treatment of Advanced Solid Tumors and Lymphomas
ClinicalTrials.gov ID: NCT02661542
Acronym / sponsor ID: FF1050201US101
Conditions: Solid Tumors, Lymphomas
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.Industry (pharma, biotech, devices)
Study start: Jan 2016 (actual)
Primary completion: 5 Nov 2020 (actual)
Study completion: 5 Nov 2020 (actual)
First posted: 22 Jan 2016 (estimated)
Results: Posted 23 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Phase 1, Cohorts 1-9	Experimental	Drug: FF-10502-01FF-10502-01 administered intravenously (IV) on Days 1, 8, and 15 of a 28-day cycle. Dosing by cohort: Cohort 1, 8mg/m2; Cohort 2, 12mg/m2; Cohort 3, 18mg/m2, Cohort 4, 27mg/m2; Cohort 5, 40mg/m2; Cohort 6, 60mg/m2; Cohort 7, 90mg/m2; Cohort 8, 135mg/m2; Cohort 9, 100mg/m2.
Phase 2a, Cohort 10, Advanced solid tumors	Experimental	Drug: FF-10502-01FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle.
Phase 2a, Cohort 11, Cholangiocarcinoma	Experimental	Drug: FF-10502-01FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle.
Phase 2a, Cohort 12, Gall bladder carcinoma	Experimental	Drug: FF-10502-01FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle.
Phase 2a, Cohort 13, Urothelial carcinoma	Experimental	Drug: FF-10502-01FF-10502-01 at 90mg/m2 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Males and females ≥ 18 years of age
Histologically or cytologically confirmed advanced or metastatic solid tumor or l lymphoma, that is refractory to standard therapy, relapsed after standard therapy, or for which no standard therapy available that is expected to improve survival by at least three months
At least 4 weeks beyond the last chemotherapy (or ≥ 5 half-lives for targeted agents, whichever is shorter), radiotherapy, major surgery or experimental treatment and recovered from all acute toxicities (≤ Grade 1)
Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2
Life expectancy of ≥ 3 months

Key exclusion criteria (7 listed)

Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV
Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care
Active central nervous system (CNS) malignant disease in subjects with a history of CNS malignancy. Subjects with stable, prior or currently treated brain metastases are allowed.
Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
Active infection requiring intravenous (IV) antibiotic usage within the last week prior to study treatment

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
FF-10502-01	Drug	Phase 1, Cohorts 1-9, Phase 2a, Cohort 10, Advanced solid tumors, Phase 2a, Cohort 11, Cholangiocarcinoma, Phase 2a, Cohort 12, Gall bladder carcinoma, Phase 2a, Cohort 13, Urothelial carcinoma

Primary outcome

Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Time frame: Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.
Safety and tolerability assessed by number of subjects with adverse events (AEs), and serious adverse events. (SAEs)

9 secondary outcomes

Number of Subjects With Overall Response Rates (ORR)
Time frame: Responses assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug (every 28 days=1 cycle), up to 38 months
Number of Subjects With Objective Response (OR) Events
Time frame: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Objective Response (OR)
Time frame: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Stable Disease (SD) Events
Time frame: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Stable Disease (SD)
Time frame: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Progression-free Survival (PFS) Events
Time frame: Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Progression-free Survival (PFS)
Time frame: Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Number of Subjects With Overall Survival (OS) Events
Time frame: Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months
Median Number of Days of Overall Survival (OS)
Time frame: Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug, up to 38 months

Results and safety

Results posted to the registry on 23 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1, Cohort 1	3	3
Phase 1 Cohort 2	3	3
Phase 1, Cohort 3	3	3
Phase 1, Cohort 4	3	3
Phase 1, Cohort 5	7	7
Phase 1, Cohort 6	3	3
Phase 1, Cohort 7	9	9
Phase 1, Cohort 8	6	6
Phase 1, Cohort 9	3	3
Phase 2a, Cohort 10, Advanced Solid Tumors	19	19
Phase 2a, Cohort 11, Cholangiocarcinoma	36	36
Phase 2a, Cohort 12, Gall Bladder Carcinoma	10	10
Phase 2a, Cohort 13, Urothelial Carcinoma	1	1

Primary outcome: Number of Subjects With Treatment Emergent Adverse Events (TEAE)

Time frame: Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.. Number. Unit: participants

Measure	Phase 1, Cohort 1 n = 3	Phase 1, Cohort 2 n = 3	Phase 1, Cohort 3 n = 3	Phase 1, Cohort 4 n = 3	Phase 1, Cohort 5 n = 7	Phase 1, Cohort 6 n = 3	Phase 1, Cohort 7 n = 9	Phase 1, Cohort 8 n = 6	Phase 1, Cohort 9 n = 3	Phase 2a, Cohort 10, Advanced Solid Tumors n = 19	Phase 2a, Cohort 11, Cholangiocarcinoma n = 36	Phase 2a, Cohort 12, Gall Bladder Carcinoma n = 10
Any Treatment Emergent Adverse Events (TEAEs)	3	3	3	3	7	3	9	6	3	19	36	10
Any dose limiting toxicity (DLT)	0	0	0	0	1	0	0	2	2	0	0	0
Study drug-related Treatment Emergent Adverse Events (TEAEs)	3	3	3	2	7	3	8	5	3	14	36	10
Serious Treatment Emergent Adverse Events (TEAEs)	2	0	2	2	5	0	5	5	0	14	20	2
Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs)	2	1	2	2	4	2	5	5	1	17	20	5
Grade 3 or 4 drug-related Treatment Emergent Adverse Events (TEAEs)	1	0	0	0	1	0	3	2	1	6	6	2
Discontinuations due to Treatment Emergent Adverse Events (TEAEs)	0	0	0	1	0	0	1	0	0	4	5	1
Interruptions due to Treatment Emergent Adverse Events (TEAEs)	1	1	2	0	3	2	3	5	1	5	15	5

Population analysed: Safety Analysis Population

9 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
Phase 1, Cohort 1	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Phase 1, Cohort 2	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Phase 1, Cohort 3	2 of 3 (66.7%)	3 of 3 (100%)	2 of 3
Phase 1, Cohort 4	2 of 3 (66.7%)	3 of 3 (100%)	2 of 3
Phase 1, Cohort 5	5 of 7 (71.4%)	7 of 7 (100%)	1 of 7
Phase 1, Cohort 6	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Phase 1, Cohort 7	5 of 9 (55.6%)	9 of 9 (100%)	5 of 9
Phase 1, Cohort 8	5 of 6 (83.3%)	6 of 6 (100%)	0 of 6
Phase 1, Cohort 9	0 of 3 (0%)	3 of 3 (100%)	3 of 3
Phase 2a, Cohort 10, Advanced Solid Tumors	14 of 19 (73.7%)	19 of 19 (100%)	14 of 19
Phase 2a, Cohort 11, Cholangiocarcinoma	20 of 36 (55.6%)	36 of 36 (100%)	15 of 36
Phase 2a, Cohort 12, Gall Bladder Carcinoma	2 of 10 (20%)	10 of 10 (100%)	1 of 10
Phase 2a, Cohort 13, Urothelial Carcinoma	0 of 1 (0%)	1 of 1 (100%)	1 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Solid Tumors

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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.

Filip Janku, MD principal investigator

University of Texas MD Anderson Center

Gerald Falchook, MD principal investigator

Sarah Cannon Research Institute-Denver

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FF-10502-01 in people with Solid Tumors and Lymphomas, run by Fujifilm Pharmaceuticals U.S.A., Inc. at 2 sites 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 16 inclusion and 7 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects With Treatment Emergent Adverse Events (TEAE) (time frame: Each patient was followed from baseline through the treatment period (maximum treatment period up to 38 months) until long-term follow-up was completed (6 mos post end of study) or patient discontinued either by withdrawal, progressive disease or death.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02661542.

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 23 Apr 2026.