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NCT03328078PHASE1, PHASE2Recruiting

CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)

Curis, Inc.

Start Date

12/28/2017

Completion Date

10/1/2026

Summary

This is a multi-center, open-label study to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib alone or in combination with ibrutinib in adult participants with relapsed or refractory (R/R) hematologic malignancies. This trial will be completed in four parts. In Part A1, emavusertib will be evaluated first in a dose escalating monotherapy setting to establish the safety and tolerability (complete). In Part A2, emavusertib will be evaluated in combination with ibrutinib at 560 milligrams (mg) once daily (QD) or 420 mg QD as indicated by disease (Part A2 complete). Part B will comprise 2 cohorts to assess safety and efficacy of emavusertib in combination with ibrutinib in participants with R/R primary central nervous system lymphoma (PCNSL) who have directly progressed on a bruton tyrosine kinase inhibitor (BTKi). In this part of the study, emavusertib will be dosed at 100 mg or 200 mg twice daily (BID) in combination with ibrutinib in 28-day treatment cycles. Part C will comprise 3 treatment arms in the second-line setting to assess the efficacy and safety of emavusertib monotherapy, ibrutinib monotherapy, and emavusertib in combination with ibrutinib in participants with R/R PCNSL who are naïve to BTKi treatment. In this part of the study, eligible second-line participants with R/R PCNSL who are naïve to BTKi treatment will be randomized 1:1:1 to 1 of 3 treatment arms: (1) emavusertib 200 mg BID, (2) ibrutinib 560 mg QD, or (3) emavusertib 200 mg BID in combination with ibrutinib 560 mg QD.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Males and females greater than or equal to 18 years of age 2. Life expectancy of at least 3 months 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 4. Histopathologically confirmed diagnosis of PCNSL (medical record is acceptable). Cerebral biopsies are not required if imaging reveals typical images of PCNSL. 1. Participants with parenchymal lesions must have unequivocal evidence of disease progression (e.g., presence of at least 1 measurable target lesion \[≥ 10 millimeters (mm) and ≤ 40 mm in the longest diameter on brain magnetic resonance imaging \[MRI\] or head computed tomography \[CT\] on imaging within 28 days prior to Cycle 1 Day 1\]). In cases where the tumor size is smaller but still measurable and located at a critical central nervous system (CNS) location, disabling the participant and/or causing symptoms, this participant may be eligible following a discussion with the Sponsor Medical Monitor. 2. For participants limited to leptomeningeal involvement, cerebrospinal fluid (CSF) analysis (cytology and/or flow cytometry) with or without additional imaging (MRI) of the spine as clinically indicated is required to document abnormal cells within 28 days prior to Cycle 1 Day 1. Exclusion Criteria for Part B and Part C 1. Participants with only intraocular PCNSL without brain lesion or CSF involvement, T-cell lymphoma, systemic presence of lymphoma, or non-CNS lymphoma metastatic to the CNS 2. Evidence of systemic lymphoma. This must be demonstrated by a positron emission tomography (PET) scan (or CT scan with contrast if applicable) of the chest, abdomen, and pelvis at Screening (testicular ultrasound may be considered to exclude a testicular lymphoma disseminated to the brain). 3. Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) or prior history of systemic lymphoma, unless the participant has been free of the disease for ≥ 3 years. 4. Active malignancy other than PCNSL requiring systemic therapy 5. Previous BTKi treatment (Part C only). 6. History of Grade ≥ 3 rhabdomyolysis without complete recovery 7. Requirement for urgent therapy due to uncontrolled tumor mass/edema effects. 8. Received external beam radiation therapy to the CNS within 28 days prior to Cycle 1 Day 1. 9. Received prior investigational drugs (including treatment in clinical research, unapproved combination products, and new dosage forms) within 28 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1; allogeneic hematopoietic stem cell transplant (HSCT) within 60 days prior to Cycle 1 Day 1; or had clinically significant graft-versus-host disease (GVHD) requiring ongoing up-titration of immunosuppressive medications prior to Screening (with the exception of a BTKi for Part B only). Note: The use of a stable or tapering dose of immunosuppressive therapy post-HSCT and/or topical steroids for ongoing skin GVHD is permitted with Sponsor Medical Monitor approval 10. Any prior systemic anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 14 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1 (with the exception of ibrutinib or other BTKi for Part B only, which may be continued until the day before Cycle 1 Day 1) 11. Prior history of hypersensitivity or anaphylaxis to emavusertib, ibrutinib or any of their excipients.

Interventions

DRUG

Emavusertib

DRUG

Ibrutinib

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Conditions

Relapsed Hematologic MalignancyRefractory Hematologic MalignancyRelapsed Primary Central Nervous System LymphomaRefractory Primary Central Nervous System Lymphoma

Locations

St. Joseph's Hospital and Medical Center

Phoenix, Arizona 85013

United States

Mayo Clinic

Phoenix, Arizona 85054

United States

City of Hope

Duarte, California 91010

United States

Providence St. John's Health Center

Santa Monica, California 90404

United States

UCLA Department of Medicine - Hematology/Oncology

Santa Monica, California 90404

United States

Smilow Cancer Hospital at Yale-New Haven

New Haven, Connecticut 06510

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Fred and Pamela Buffett Cancer Center

Omaha, Nebraska 68198

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York 14263

United States

Mt Sinai

New York, New York 10029

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Duke University Medical Center, Duke Cancer Center

Durham, North Carolina 27710

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Providence Neurological Specialties West

Portland, Oregon 97225

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

UPMC Hilman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

University of Tennessee Medical Center

Knoxville, Tennessee 37920

United States

UT Southwestern Medical Center

Dallas, Texas 75235

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah 84112

United States

Swedish Cancer Institute

Seattle, Washington 98104

United States

University of Washington Medical Center

Seattle, Washington 98195

United States

Všeobecná fakultní nemocnice v Praze

Prague,

Czechia

Institut Bergonie

Bordeaux,

France

Hopital de la Timone

Marseille,

France

Hospital Pitie Salpetriere

Paris,

France

Institut Curie Hospital

Paris,

France

Hematology Department Soroka UMC / Heanatology Department

Beersheba,

Israel

Rambam Medical Center

Haifa,

Israel

Hadassah Medical Center / Ein-Carem

Jerusalem,

Israel

Università di Torino Croce e Carle

Cuneo,

Italy

SODc Ematologia Azienda Ospedaliera Universitaria Careggi

Florence,

Italy

IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola,

Italy

IRCCS San Raffaele Scientific Institute

Milan,

Italy

Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz

Gdansk,

Poland

Oddzial Kliniczny Hematologii

Krakow,

Poland

NarodowyInstytutu Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytutu Badawczy

Warsaw,

Poland

University Hospital Vall d'Hebron

Barcelona,

Spain

MD Anderson Cancer Center Madrid

Madrid,

Spain

Hospital Universitario Virgen del Rocio

Seville,

Spain