Study of Oral LOXO-338 in Patients With Advanced Blood Cancers

Completed · Phase 1

Conditions studied: Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-cell Marginal Zone, Lymphoma, Non-Hodgkin, Multiple Myeloma, B-cell Lymphoma, Waldenstrom Macroglobulinemia, Lymphoma, Mantle-Cell

In brief

The purpose of this study is to find out whether the study drug, LOXO-338, is safe and effective in patients with advanced blood cancer. Patients must have already received standard therapy. The study may last up to approximately 3 years.

Key facts

Study ID

NCT05024045

Run by

Eli Lilly and Company

People needed

27

Starts

2021-09-30

Expected to finish

2026-04-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• B-cell malignancy.
• Patients must have received prior therapy.
• Patients must have an objective indication for therapy.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
• Anticipated life expectancy of greater than or equal to (≥) 12 weeks.
• Adequate bone marrow function.
• Adequate hepatic function.
• Creatinine clearance of ≥ 60 milliliters (mL)/minute.
• Ability to swallow tablets.
• Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
• Prior treatment-related adverse events (AEs) must have recovered to grade less than or equal to (≤) 1 or pretreatment baseline, with the exception of alopecia.
• Men with partners of childbearing potential or women of childbearing potential (WOCBP) must agree to use highly effective birth control.
• WOCBP must not be pregnant.
• Additional Inclusion Criteria for Patients with AL Amyloidosis
• In Part 1 Dose Expansion, patients with AL amyloidosis are eligible based on prior detection of primary systemic light-chain amyloidosis.
• Must have measurable disease of AL amyloidosis.
• Prior local fluorescence in-situ hybridization (FISH) testing results for t(11;14) are required to be submitted prior to enrollment.

You may not qualify if…

• Prior to identification of an appropriate RP2D (Dose Expansion) of LOXO-338, a history of known, active or suspected:
• Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocyticleukemia, or Hodgkin lymphoma
• Transformed low grade lymphoma
• Burkitt or Burkitt-like lymphoma
• Diffuse large B-cell lymphoma
• AL amyloidosis
• Multiple myeloma
• Lymphoblastic lymphoma or leukemia
• Posttransplant lymphoproliferative disorder
• Known or suspected history of central nervous system (CNS) involvement.
• History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T cell (CAR-T) therapy within the past 60 days and with any of the following:
• Active graft versus host disease (GVHD)
• Cytopenias from incomplete blood cell count recovery post-transplant or CAR-T therapy
• Need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity Grade > 1 from CAR-T therapy
• Ongoing immunosuppressive therapy
• Known human immunodeficiency virus (HIV) positive, regardless of cluster of differentiation 4 (CD4) count. Unknown or negative status eligible.
• Inability to take necessary uric acid lowering agents (i.e., allopurinol, rasburicase, orfebuxostat).
• Concurrent anticancer therapy.
• Concurrent treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers that can include antifungals.
• Use of ≥ 20 milligrams (mg) prednisone once a day (QD) or equivalent dose of steroid per day, within 7 days of start of study treatment. Patients may not be on any dose of prednisone intended for antineoplastic use.
• Vaccination with a live vaccine within 28 days prior to start of study therapy.
• Major surgery within four weeks of planned start of study therapy Prolongation of the QT interval corrected by Fridericia's Formula for heart rate (QTcF) greater than (>) 470 milliseconds (msec).
• Clinically significant cardiovascular disease.
• Female patient who is pregnant or lactating.
• Active second malignancy which may preclude assessment of DLT.

Where it is running

• The University of Arizona Cancer Center — Tucson, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• University of California San Francisco, Medical Center at Paranassus — San Francisco, California, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana Blood & Marrow Transplantation (IBMT) — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Westwood, Kansas, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Swedish Medical Center — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• L'Institut Universitaire du Cancer de Toulouse Oncopole — Toulouse, Cedex 9, France
• Centre Hospitalier Lyon Sud — Pierre-Bénite, Cedex, France
• CHRU de Montpellier-Hopital St Eloi — Montpellier, France
• Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu — Nantes, France
• Institut Curie — Paris, France
• Centre hospitalier universitaire de Haut Leveque — Pessac, France
• IRCCS - AOU di Bologna — Bologna, Italy
• Centrum Medyczne Pratia Poznan — Skorzewo, Poznan, Poland
• Pratia MCM Krakow — Krakow, Poland
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy — Warsaw, Poland

Full record on ClinicalTrials.gov

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