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Solid TumorsPhase 1/2NCT02503423

Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

A Phase 1/2 study testing ASTX660 in people with Solid Tumors and Lymphoma, run by Taiho Oncology, Inc. at 68 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors, Lymphoma
What is being tested?
ASTX660
Could I receive a placebo?
No, everyone receives an active treatment
How many people
253 participants
Where
68 sitesin 8 countries
Study dates
14 Jul 2015to Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Able to understand and comply with the protocol and study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure is performed.
  • Men and women 18 years of age or older.
  • Participants with histologically or cytologically confirmed advanced solid tumors or lymphoma that is metastatic or unresectable, and for whom standard life-prolonging measures are not available. Specific tumor types that will be selected for study in Phase 2 are detailed in the protocol.
  • For Phase 2 Cohort 3, participants must have histologically confirmed PTCL (local pathology report) as defined by 2016 World Health Organization (WHO) classification. The following subtypes are eligible for the study: adult T-cell lymphoma/leukemia, extranodal natural killer (NK)/T-cell lymphoma nasal type, enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, nodal peripheral T-cell with T-follicular helper (THF) phenotype, and anaplastic large-cell lymphoma.
  • For Phase 2 Cohorts 3 and 4, participants must have evidence of documented progressive disease and must have received at least two prior systemic therapies.
  • Participants with CD30-positive lymphoma must have received, be ineligible for, or intolerant to brentuximab vedotin, provided that brentuximab vedotin is locally approved and available.
Show all 22Show fewer
  • Participants with mycosis fungoides or Sezary syndrome must have received, be ineligible or intolerant to mogamulizumab, provided that mogamulizumab is locally approved and available.
  • In the Phase 2 portion of the protocol only, participants must have measurable disease according to response criteria appropriate for their type of cancer.
  • For Phase 2 Cohort 3 (PTCL), measurable disease by contrast-enhanced diagnostic CT (at least 1 nodal lesion >1.5 cm or extranodal lesions >1.0 cm) is required.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Acceptable organ function, as evidenced by the following laboratory data:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.0 * upper limit of normal (ULN).
  • Total serum bilirubin <=1.5 * ULN
  • Absolute neutrophil count (ANC):
  • Phase 1 and 2 (except Phase 2 participants with known lymphoma; ie, not applicable for Cohorts 3 or 4) >=1500 cells/mm3
  • Phase 2 participants with known lymphoma: >=1000 cells/mm3 (>750 cell/mm3 for participants with lymphoma in bone marrow)
  • Platelet count:
  • Phase 1 and 2 (except Phase 2 participant with known lymphoma; ie, not applicable for Cohorts 3 or 4) >=100,000 cells/mm3
  • Phase 2 participants with known lymphoma: >= 50,000 cells/mm3; >=25,000 cells/mm3 for participants with lymphoma in bone marrow
  • Serum creatinine levels <= 1.5 * ULN, or calculated (by Cockcroft-Gault formula or other accepted formula) or measure creatinine clearance >=50 mL/min.
  • Amylase and lipase <=ULN.
  • Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]; see protocol for details) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures of birth control (as described in the protocol) and must agree not to become pregnant or father a child while receiving treatment with study drug and for at least 3 months after completing treatment. Contraceptive measures which may be considered highly effective comprise combined hormonal contraception (oral, vaginal, or transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, sexual abstinence, and surgically successful vasectomy. Abstinence is acceptable only if it is consistent with the preferred and usual lifestyle of the participant. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of birth control.

Who cannot join

  • Hypersensitivity to ASTX660, excipients of the drug product, or other components of the study treatment regimen.
  • Poor medical risk because of systemic diseases (e.g. active uncontrolled infections) in addition to the qualifying disease under study.
  • Life-threatening illness, significant organ system dysfunction, or other condition that, in the investigator's opinion, could compromise participant safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of ASTX660.
  • History of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions:
  • Abnormal left ventricular ejection fraction (LVEF; <50%) or echocardiogram ECHO or multiple gated acquisition scan (MUGA).
  • Congestive cardiac failure of >= Grade 3 severity according to New York Heart Association (NYHA) functional classification defined as participants with marked limitation of activity and who are comfortable only at rest.
Show all 26Show fewer
  • Unstable cardiac disease including angina or hypertension as defined by the need for overnight hospital admission within the last 3 months (90 days).
  • History or presence of complete left bundle branch block, heart block, cardiac pacemaker or significant arrhythmia.
  • Concurrent treatment with any medical that prolongs QT interval and may induce torsades de pointes, and which cannot be discontinued at least 2 weeks before treatment with ASTX660. [Applies to Phase 1 only].
  • Personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy.
  • Screening 12-lead ECG with measurable QTc interval (according to either Fridericia's or Bazett's correction) of >=470 msec).
  • Any other condition that, in the opinion of the investigator, could put the participant at increased cardiac risk.
  • Known history of human immunodeficiency virus (HIV) infection, or seropositive results consistent with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
  • Grade 2 or greater neuropathy [Applies to Phase 1]. Grade 3 or greater neuropathy [Applies to Phase 2].
  • Known brain metastases, unless stable or previously treated.
  • Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the participant to high risk of noncompliance with the protocol treatment or assessments.
  • Prior anticancer treatments or therapies within the indicated time window prior to first dose of study treatment (ASTX660), as follows:
  • Cytotoxic chemotherapy or radiotherapy within 3 weeks prior and any encountered treatment-related toxicities (excepting alopecia) not resolved to Grade 1 or less [Phase 1] or Grade 2 or less [Phase 2].
  • Skin directed treatments, including topicals and radiation within 2 weeks prior.
  • Monoclonal antibodies within 4 weeks prior and any encountered treatment-related toxicities not resolved to Grade 1 or less [Phase 1] or Grade 2 or less [Phase 2].
  • Small molecules or biologics (investigational or approved) within the longer of 2 weeks or 5 half-lives prior to study treatment and any encountered treatment-related toxicities not resolved to Grade 1 or less [Phase 1] or Grade 2 or less [Phase 2].
  • At least 6 weeks must have elapsed since CAR-T infusion and participants must have experienced disease progression, and not have residual circulating CAR-T cells in peripheral blood (based on local assessment). Any encountered treatment-related toxicities must have resolved to Grade ≤1.
  • Concurrent second malignancy currently requiring active therapy, except breast or prostate cancer stable on or responding to endocrine therapy or superficial bladder cancer [Phase 2].
  • Known central nervous system (CNS) lymphoma [Phase 2].
  • Participants with a history of allogenic transplant must not have ≥Grade 3 graft-versus-host disease (GVHD) or any clinically significant GVHD requiring systemic immunosuppression [Phase 2].
  • Systemic corticosteroids >20 mg prednisone equivalent (unless participant has been taking a continuous dose for >3 weeks prior to study entry and there is documented radiological progression) [Phase 2]. Stable dose of medium or low potency topical corticosteroids for at least 3 weeks prior to study entry are permitted [Phase 2].

Trial locations and contacts

68 sites in 8 countries.

68 sites in 8 countries

United States31 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University winship Cancer Institute

    Atlanta, Georgia, 30322

  • The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

  • The Ohio State University and Wexner Medical Center, James Cancer Hospital

    Columbus, Ohio, 43210

  • Summit Medical Group - Florham Park Campus/Atlantic Health

    Florham Park, New Jersey, 07932

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • CliniCore Texas

    Houston, Texas, 77079

  • Dartmouth-Hitchcock Medical Center (DHMC)

    Lebanon, New Hampshire, 03766

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37212

  • Simlow Cancer Hospital at Yale

    New Haven, Connecticut, 06510

  • New York University Langone Medical Center

    New York, New York, 10016

  • New York Presbyterian Hospital Columbia University Medical Center

    New York, New York, 10019

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • University of Oklahoma Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Virgina Commonwealth University

    Richmond, Virginia, 23298

  • Rochester Skin Lymphoma Medical Group

    Rochester, New York, 14450

  • UC Davis Medical Center

    Sacramento, California, 95817

  • START- South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

  • HonorHealth Research Institute

    Scottsdale, Arizona, 852558

  • University of Washington, Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

United Kingdom9 sites

  • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Beatson Cancer Center and University of Glasgow

    Glasgow, G12 0XL

  • University Hospitals of Leicester NHS Trust

    Leicester, East Midlands, LE1 5WW

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

  • Guy's and Saint Thomas' NHS Foundation Trust

    London, SE1 9RT

  • The Christie NHS Foundation Trust, Christie Hospital

    Manchester, M20 4BX

  • Churchill Hospital, Oxford University Hospital NHS Trust

    Oxford, Oxfordshire, OX3 7LE

  • University Hospital Southhampton NHS Foundation Trust - Somers Cancer Research

    Southampton, Hampshire, SO16 6YD

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Canada7 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta

  • Nova Scotia Health Athority-Qeii HSC

    Halifax, Nova Scotia, B3H 2Y9

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M56 2M9

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

France7 sites

  • Institut Bergonié, Unicancer

    Bordeaux, 33000

  • Centre Antoine Lacassagne, Oncologie Médicale

    Nice, 06189

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Lyon, 69310

  • Centre Henri Becquerel, Hematology

    Rouen, 1,76-38

  • Institut Universitaire du Cancer - Oncopôle, Department d'Hématologie

    Toulouse, 31059

  • CRU de Tours - Hôpital Bretonneau, Hématologie -Thérapy Cellulaire

    Tours, 37044

  • Gustave Roussy Cancer Campus (IGR)

    Villejuif, Cedex, 94805

Other trials in France

Italy4 sites

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

    Bologna, 40138

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia, 25123

  • Instituto Europeo di Oncologia

    Milan

  • Azienda Socio Santaria Territoriale Monza- Osperdale San Gerado

    Monza

Other trials in Italy

Spain4 sites

  • Institut Catala d'Oncologia

    Girona, Giona

  • Hospital Universitario Fundacion Jimenez Diaz Preview

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • imCORE - Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

Belgium3 sites

  • Intitut Jules Boredt

    Brussels, 1000

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen, 9000

  • Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

    Yvoir, Namur, B-5530

Other trials in Belgium

Hungary3 sites

  • Semmelweis Egyetem - I. sz. Belgyógyászati Klinika

    Budapest, 1083

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032

  • Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház

    Nyíregyháza

Other trials in Hungary

About this study

Official title: Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available.

Read the detailed description

ASTX660 is a synthetic small molecule dual antagonist of cellular inhibitor of apoptosis protein (cIAP) 1 and X-linked inhibitor of apoptosis protein (XIAP) that has been shown to have potent proapoptotic and tumor growth inhibitory activity in nonclinical models. The Phase 1 portion of the study (completed) will determine the MTD, RP2D, and recommended dosing regimen. The Phase 2 portion will evaluate activity in selected tumor types. Subjects will continue to receive their assigned treatment throughout the study until the occurrence of disease progression, death, or unacceptable treatment-related toxicity, or until the study is closed by the sponsor.

Being tested
ASTX660
Keywords
cervical cancer, HNSCC, CTCL, PTCL, DLBCL
Medical subject headings
Lymphoma, Uterine Cervical Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • ASTX660Drug

    Also called Treatment of ASTX660 for advanced solid tumors and lymphomas

    described above

Study groups in NCT02503423
Study groupRoleWhat they receive
Phase 1 - Part 1 (completed)ExperimentalDose-escalation stage to identify the MTD and the RP2D, defined as either the MTD or a dose below the MTD that the Data and Safety Review Committee (DSRC) agree shows adequate pharmacological evidence of target engagement and/or clinical activity. Subjects will receive ASTX660 once a day for 7 consecutive days every other week of each 28-day cycle (ie, [7 days on/ 7 days off] ×2; daily dosing on Days 1-7 and 15-21). The starting dose will be escalated stepwise in successive cohorts of 3 to 6 evaluable subjects each (standard 3+3 study design), until the RP2D is determined.
Receives: Drug: ASTX660
Phase 1 - Part 2 (completed)ExperimentalDose-expansion stage to confirm tolerability of ASTX660 at the RP2D using the every-other-week daily dosing regimen. Up to a total of 12 subjects (including the 3 or 6 subjects treated at the RP2D in Part 1) will be treated at the RP2D.
Receives: Drug: ASTX660
Phase 1 - Part 3 (optional)ExperimentalThe purpose of the optional Part 3 is to allow for exploration of an alternative dosing regimen of ASTX660 based on emerging safety, PK, and pharmacodynamic (PD) data from Parts 1 and 2 (using the original every-other-week dosing regimen), with agreement of the DSRC. If Part 3 is conducted, the plan is to enroll up to 18 evaluable subjects in 1 or more cohorts using a standard 3+3 study design.
Receives: Drug: ASTX660
Phase 2 - Cohort 1ExperimentalTreatment with ASTX660 for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) not responsive or relapsed after standard therapy.
Receives: Drug: ASTX660
Phase 2 - Cohort 2ExperimentalTreatment with ASTX660 for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Receives: Drug: ASTX660
Phase 2 - Cohort 3ExperimentalTreatment with ASTX660 for progressive or relapsed peripheral T-cell lymphoma (PTCL).
Receives: Drug: ASTX660
Phase 2 - Cohort 4ExperimentalTreatment with ASTX660 for relapsed or refractory cutaneous T-cell lymphoma (CTCL).
Receives: Drug: ASTX660
Phase 2 - Cohort 5ExperimentalTreatment with ASTX660 for other tumor types that are characterized by a molecular feature that may confer sensitivity to ASTX660 (eg, oncogenic activation of the NF-κB pathway or documented amplification of the gene loci encoding c-IAP1 or c-IAP2), pending confirmation in writing by the Astex medical monitor.
Receives: Drug: ASTX660
Phase 2 - Cohort 6ExperimentalTreatment with ASTX660 for cervical carcinoma not responsive or relapsed after standard therapy.
Receives: Drug: ASTX660

What is being measured

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

  1. Safety (Phase 1) - number of subjects with AEs, DLTs, abnormal clinical laboratory values or physical exam results

    Incidence of dose-limiting toxicities (DLTs) and other adverse events (AEs)

    Measured: Up to 78 months

  2. Efficacy (Phase 2) - antitumor activity assessed by objective response rate (ORR)

    Antitumor activity by objective response rate

    Measured: Up to 84 months

  3. Efficacy (Phase 2) - antitumor activity assessed by disease control rate (DCR)

    Antitumor activity by disease control rate

    Measured: Up to 84 months

Secondary outcomes (11)

  1. Pharmacokinetic outcome of concentration-time curve (AUC)

    Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).

    Measured: First 9 weeks of study treatment

  2. Pharmacokinetic outcome of maximum concentration (Cmax)

    Assessment of pharmacokinetic parameter maximum concentration (Cmax).

    Measured: First 9 weeks of study treatment

  3. Pharmacokinetic outcome of minimum concentration (Cmin)

    Assessment of pharmacokinetic parameter minimum concentration (Cmin).

    Measured: First 9 weeks of study treatment

  4. Pharmacokinetic outcome of time to maximum concentration (Tmax)

    Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)

    Measured: First 9 weeks of study treatment

  5. Pharmacokinetic outcome of samples over time

    Assessment of pharmacokinetic parameter elimination half life (t½).

    Measured: First 9 weeks of study treatment

  6. Pharmacokinetic outcome of samples over time

    Assessment of pharmacokinetic parameter of other secondary PK parameters of ASTX660 if data permit.

    Measured: First 9 weeks of study treatment

  7. Pharmacokinetic outcome of analysis of ASTX660 metabolites if applicable

    Assessment of pharmacokinetic parameter analysis of ASTX660 metabolites if applicable.

    Measured: First 9 weeks of study treatment

  8. Duration of antitumor response

    Time from the date of the earliest assessment of complete response or partial response to the date of relapse or death, whichever occurs earlier, or the last efficacy assessment date for subjects without a relapse or death.

    Measured: Up to 84 months

  9. Progression-free survival

    Number of days from the start of the study treatment to disease progression or death, whichever occurs first.

    Measured: Up to 84 months

  10. Overall survival

    Number of days from the day the subject received the first study treatment to the date of death, regardless of cause.

    Measured: Up to 84 months

  11. Assessment of target (cIAP1) engagement

    Percentage degradation of cIAP1 protein in PBMCs from baseline, in response to ASTX660 treatment.

    Measured: Up to 84 months

Timeline

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

  1. First posted21 Jul 2015 (estimated)
  2. Study start14 Jul 2015
  3. Primary completionOct 2022
  4. Study completionDec 2027 (estimated)

Resources

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
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02503423
Sponsor's protocol ID
ASTX660-01
Other IDs
2016-005039-34, HC6-24-c206781, 2016
Status last verified
Mar 2026
First submitted
2 Jul 2015
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Johnson CN, Ahn JS, Buck IM, Chiarparin E, Day JEH, Hopkins A, Howard S, Lewis EJ, Martins V, Millemaggi A, Munck JM, Page LW, Peakman T, Reader M, Rich SJ, Saxty G, Smyth T, Thompson NT, Ward GA, Williams PA, Wilsher NE, Chessari G. A Fragment-Derived Clinical Candidate for Antagonism of X-Linked and Cellular Inhibitor of Apoptosis Proteins: 1-(6-[(4-Fluorophenyl)methyl]-5-(hydroxymethyl)-3,3-dimethyl-1 H,2 H,3 H-pyrrolo[3,2- b]pyridin-1-yl)-2-[(2 R,5 R)-5-methyl-2-([(3R)-3-methylmorpholin-4-yl]methyl)piperazin-1-yl]ethan-1-one (ASTX660). J Med Chem. 2018 Aug 23;61(16):7314-7329. doi: 10.1021/acs.jmedchem.8b00900. Epub 2018 Aug 9.

    PubMed 30091600

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ASTX660 in people with Solid Tumors and Lymphoma, run by Taiho Oncology, Inc. at 68 sites in 8 countries.

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 22 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, United Kingdom, Canada, France, Italy and 3 more countries. 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?

This study is still under way. Results are not available in the source record yet.

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?

Safety (Phase 1) - number of subjects with AEs, DLTs, abnormal clinical laboratory values or physical exam results (time frame: Up to 78 months). The study lists 3 primary outcomes in all. 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 NCT02503423, which also lists 1 linked publication.

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 20 Mar 2026.

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