New cancer drug ASTX660 tested in patients with no other options

NCT ID NCT02503423

Disease control Sponsor: Taiho Oncology, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called ASTX660 in people with advanced solid tumors or lymphomas that have not responded to standard treatments. The trial has two phases: first, to find the safest dose and check for side effects, and second, to see if the drug can shrink tumors or control the disease. About 253 adults are taking part in this open-label study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ASTX660
What this could lead to: If successful, ASTX660 could offer a new treatment option for people with advanced solid tumors or lymphomas who have run out of standard therapies.
What could go wrong: This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects are possible and being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

253 people

The number who actually took part.

Started

Jul 2015

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Men and women 18 years of age or older. 3. 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. a. 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. 4. 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. 1. 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. 2. Participants with mycosis fungoides or Sezary syndrome must have received, be ineligible or intolerant to mogamulizumab, provided that mogamulizumab is locally approved and available. 5. In the Phase 2 portion of the protocol only, participants must have measurable disease according to response criteria appropriate for their type of cancer. a. 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. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 7. Acceptable organ function, as evidenced by the following laboratory data: 1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<=2.0 \* upper limit of normal (ULN). 2. Total serum bilirubin \<=1.5 \* ULN 3. 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) 4. 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 5. Serum creatinine levels \<= 1.5 \* ULN, or calculated (by Cockcroft-Gault formula or other accepted formula) or measure creatinine clearance \>=50 mL/min. 6. Amylase and lipase \<=ULN. 8. 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. Exclusion Criteria: 1. Hypersensitivity to ASTX660, excipients of the drug product, or other components of the study treatment regimen. 2. Poor medical risk because of systemic diseases (e.g. active uncontrolled infections) in addition to the qualifying disease under study. 3. 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. 4. History of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions: 1. Abnormal left ventricular ejection fraction (LVEF; \<50%) or echocardiogram ECHO or multiple gated acquisition scan (MUGA). 2. 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. 3. Unstable cardiac disease including angina or hypertension as defined by the need for overnight hospital admission within the last 3 months (90 days). 4. History or presence of complete left bundle branch block, heart block, cardiac pacemaker or significant arrhythmia. 5. 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. \[Applies to Phase 1 only\]. 6. Personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy. 7. Screening 12-lead ECG with measurable QTc interval (according to either Fridericia's or Bazett's correction) of \>=470 msec). 8. Any other condition that, in the opinion of the investigator, could put the participant at increased cardiac risk. 5. 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. 6. Grade 2 or greater neuropathy \[Applies to Phase 1\]. Grade 3 or greater neuropathy \[Applies to Phase 2\]. 7. Known brain metastases, unless stable or previously treated. 8. 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. 9. Prior anticancer treatments or therapies within the indicated time window prior to first dose of study treatment (ASTX660), as follows: 1. 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 \[Phase 2\]. 2. Skin directed treatments, including topicals and radiation within 2 weeks prior. 3. 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 \[Phase 2\]. 4. 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 \[Phase 2\]. 5. 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. 10. Concurrent second malignancy currently requiring active therapy, except breast or prostate cancer stable on or responding to endocrine therapy or superficial bladder cancer \[Phase 2\]. 11. Known central nervous system (CNS) lymphoma \[Phase 2\]. 12. 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 \[Phase 2\]. 13. 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 \[Phase 2\].

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Conditions

The condition(s) this trial relates to.

lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma neoplasm Squamous Cell Carcinoma of Head and Neck Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma Solid tumors

Contacts and locations

Locations

Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

Bologna, 40138, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, 25123, Italy
Azienda Socio Santaria Territoriale Monza- Osperdale San Gerado

Monza, Italy
Beatson Cancer Center and University of Glasgow

Glasgow, G12 0XL, United Kingdom
British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada
CRU de Tours - Hôpital Bretonneau, Hématologie -Thérapy Cellulaire

Tours, 37044, France
Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Centre Antoine Lacassagne, Oncologie Médicale

Nice, 06189, France
Centre Henri Becquerel, Hematology

Rouen, 1,76-38, France
Centre Hospitalier Lyon Sud

Pierre-Bénite, Lyon, 69310, France
Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

Yvoir, Namur, B-5530, Belgium
Churchill Hospital, Oxford University Hospital NHS Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom
CliniCore Texas

Houston, Texas, 77079, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Dartmouth-Hitchcock Medical Center (DHMC)

Lebanon, New Hampshire, 03766, United States
Debreceni Egyetem Klinikai Központ

Debrecen, 4032, Hungary
Emory University winship Cancer Institute

Atlanta, Georgia, 30322, United States
Gustave Roussy Cancer Campus (IGR)

Villejuif, Cedex, 94805, France
Guy's and Saint Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom
Hollings Cancer Center

Charleston, South Carolina, 29425, United States
HonorHealth Research Institute

Scottsdale, Arizona, 852558, United States
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario Fundacion Jimenez Diaz Preview

Madrid, 28040, Spain
Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States
Institut Bergonié, Unicancer

Bordeaux, 33000, France
Institut Catala d'Oncologia

Girona, Giona, Spain
Institut Universitaire du Cancer - Oncopôle, Department d'Hématologie

Toulouse, 31059, France
Instituto Europeo di Oncologia

Milan, Italy
Intitut Jules Boredt

Brussels, 1000, Belgium
Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada
MD Anderson Cancer Center

Houston, Texas, 77030, United States
New York Presbyterian Hospital Columbia University Medical Center

New York, New York, 10019, United States
New York University Langone Medical Center

New York, New York, 10016, United States
Nova Scotia Health Athority-Qeii HSC

Halifax, Nova Scotia, B3H 2Y9, Canada
Oregon Health and Science University

Portland, Oregon, 97239, United States
Princess Margaret Cancer Centre

Toronto, Ontario, M56 2M9, Canada
Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611, United States
Rochester Skin Lymphoma Medical Group

Rochester, New York, 14450, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
START- South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States
Semmelweis Egyetem - I. sz. Belgyógyászati Klinika

Budapest, 1083, Hungary
Simlow Cancer Hospital at Yale

New Haven, Connecticut, 06510, United States
Summit Medical Group - Florham Park Campus/Atlantic Health

Florham Park, New Jersey, 07932, United States
Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada
Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház

Nyíregyháza, Hungary
The Christie NHS Foundation Trust, Christie Hospital

Manchester, M20 4BX, United Kingdom
The Ohio State University and Wexner Medical Center, James Cancer Hospital

Columbus, Ohio, 43210, United States
The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

Baltimore, Maryland, 21287, United States
Tom Baker Cancer Centre

Calgary, Alberta, Canada
Tufts Medical Center

Boston, Massachusetts, 02111, United States
UC Davis Medical Center

Sacramento, California, 95817, United States
USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, 9000, Belgium
University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom
University Hospital Southhampton NHS Foundation Trust - Somers Cancer Research

Southampton, Hampshire, SO16 6YD, United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom
University Hospitals of Leicester NHS Trust

Leicester, East Midlands, LE1 5WW, United Kingdom
University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Oklahoma Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States
University of Washington, Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States
Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37212, United States
Virgina Commonwealth University

Richmond, Virginia, 23298, United States
Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States
West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States
imCORE - Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

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