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New pill targets genetic weakness in Hard-to-Treat blood cancers

NCT ID NCT04603001

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study tests an experimental oral drug called LY3410738 in people with advanced blood cancers such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) that have specific IDH1 or IDH2 gene mutations. The drug is designed to block the mutated IDH proteins that help cancer grow. The trial aims to find the safest dose and measure how well the drug works, both alone and in combination with other treatments.

What this could mean

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

Active substance
LY3410738
What this could lead to
If successful, this could provide a new targeted treatment option for people with certain blood cancers that have IDH1 or IDH2 mutations.
What could go wrong
This is an early phase 1 trial, so the drug may not work as hoped or could have unexpected side effects. The results are preliminary and may not lead to a widely available treatment.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

May 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: * Advanced IDH mutant hematologic malignancy including: \-- For Dose Escalation Arm C and Dose Expansion Cohort 5: * Patients with newly diagnosed AML who are 75 years or older or have comorbidities that preclude the use of intensive chemotherapy * Patients with R/R AML (US only) * Patients must have received prior therapy * Blasts at least 5% in bone marrow. * Patients must have a qualifying IDH1 R132, IDH2 R140 or IDH2 R172 mutation * Eastern Cooperative Oncology Group (ECOG) 0 to 2 * Adequate organ function * Ability to swallow capsules or tablets * Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation * Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following the last dose of study treatment. Exclusion Criteria: * Investigational agent or anticancer therapy within 2 weeks or 5 half-lives, whichever is shorter; or investigational monoclonal antibody within 4 weeks prior to planned start of LY3410738 * For Dose Escalation Arm C and Dose Expansion Cohort 5: * Prior venetoclax treatment is not allowed. * Patients are allowed to receive up to 1 cycle of single agent azacitidine or azacitidine plus venetoclax while waiting for results of locally obtained molecular profiling, including IDH1/IDH2 mutational status, prior to starting on study. * Major surgery within 4 weeks prior to planned start of LY3410738. * Active, uncontrolled clinically significant systemic bacterial, viral, fungal or parasitic infection or an unexplained fever \> 38.5ºC during Screening or on the first day of study drug administration. * Another concurrent malignancy requiring active therapy. * Active central nervous system involvement * Any unresolved toxicities from prior therapy greater than CTCAE v5.0 Grade 2 at the time of starting study treatment except for alopecia. * History of hematopoietic stem cell transplant (HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 60 days of the first dose of LY3410738. * Clinically significant cardiovascular disease * Active hepatitis B virus (HBV) * Active hepatitis C virus (HCV) * Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug * Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or P- glycoprotein (P-gp) inhibitor, with the exception of patients being treated with allowed antifungal inhibitors of CYP3A4 * Treatment with proton pump inhibitor (PPIs) within 7 days of starting LY3410738 * Any serious underlying medical or psychiatric condition (e.g. alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to understand informed consent or that in the opinion of the Investigator would contraindicate the patient's participation in the study or confound the results of the study * Known human immunodeficiency virus (HIV), excluded due to potential drug-drug interactions between antiretroviral medications and LY3410738 * Pregnancy, lactation or plan to breastfeeding during the study or within 90 days of the last dose of study intervention * Known hypersensitivity to any of the components of LY3410738 or its formulation

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia chronic myelomonocytic leukemia myelodysplastic syndrome Myelodysplastic Syndromes Myeloproliferative Disorders myeloproliferative neoplasm

As listed by the trial registrant

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

Acute myeloid leukemia (AML) Chronic myelomonocytic leukemia (CMML) Myelodysplastic syndrome (MDS) Myeloproliferative neoplasms (MPNS)

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

  • BC Cancer Vancouver

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Centre hospitalier universitaire de Haut Leveque

    Pessac, 33604, France

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Clinico Y Provincial Barcelona

    Barcelona, 8036, Spain

  • Cliniques universitaires Saint-Luc

    Brussels, 1200, Belgium

  • H Lee Moffitt Cancer Center

    Tampa, Florida, 33612-9497, United States

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

    Helsinki, 00290, Finland

  • Hopital Saint Louis

    Paris, 75010, France

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026, Spain

  • Institut Claudius Regaud

    Toulouse, 31059, France

  • Institut Paoli-Calmettes

    Marseille, 13273, France

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Linear Clinical Research

    Nedlands, Western Australia, 6009, Australia

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medizinische Hochschule Hanover

    Hanover, Lower Saxony, 30625, Germany

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National University Cancer Institute

    Singapore, 119228, Singapore

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Hospital

    Toronto, Ontario, M5G2M9, Canada

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0002, United States

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Singapore General Hospital

    Singapore, 169608, Singapore

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

  • University of California, Davis - Health Systems

    Sacramento, California, 95817, United States

  • University of Chicago Hospital

    Chicago, Illinois, 60637, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.