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Clinical Trials in the USA / NCT03328078
Recruiting Phase 1/2

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)

NCT03328078 · tracked via the Priya Life Science USA tracker
Sponsor
Curis, Inc.
Phase
Phase 1/2
Started
2017-12-28
Last updated
2026-04-16

Condition(s) studied

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

Investigational drug(s) / intervention(s)

EmavusertibIbrutinib

Emavusertib: Emavusertib will be provided as a tablet dosage form to be taken BID.

Ibrutinib: Ibrutinib will be provided as a tablet or capsule dosage form to be taken QD.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
St. Joseph's Hospital and Medical Center Phoenix Arizona Recruiting
Mayo Clinic Phoenix Arizona Completed
City of Hope Duarte California Recruiting
Providence St. John's Health Center Santa Monica California Recruiting
UCLA Department of Medicine - Hematology/Oncology Santa Monica California Withdrawn
Smilow Cancer Hospital at Yale-New Haven New Haven Connecticut Completed
Mayo Clinic Jacksonville Florida Recruiting
Northwestern Memorial Hospital Chicago Illinois Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Fred and Pamela Buffett Cancer Center Omaha Nebraska Recruiting
Hackensack University Medical Center Hackensack New Jersey Completed
Roswell Park Comprehensive Cancer Center Buffalo New York Recruiting
Mt Sinai New York New York Recruiting
Columbia University Irving Medical Center New York New York Withdrawn
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Duke University Medical Center, Duke Cancer Center Durham North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Providence Neurological Specialties West Portland Oregon Recruiting
Hospital of the University of Pennsylvania Philadelphia Pennsylvania Completed
UPMC Hilman Cancer Center Pittsburgh Pennsylvania Recruiting
University of Tennessee Medical Center Knoxville Tennessee Completed
UT Southwestern Medical Center Dallas Texas Active Not Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Huntsman Cancer Institute, University of Utah Salt Lake City Utah Recruiting
Swedish Cancer Institute Seattle Washington Completed
University of Washington Medical Center Seattle Washington Recruiting
Všeobecná fakultní nemocnice v Praze Prague Czechia Recruiting
Institut Bergonie Bordeaux France Recruiting
Hopital de la Timone Marseille France Recruiting
Hospital Pitie Salpetriere Paris France Recruiting
Institut Curie Hospital Paris France Recruiting
Hematology Department Soroka UMC / Heanatology Department Beersheba Israel Recruiting
Rambam Medical Center Haifa Israel Recruiting
Hadassah Medical Center / Ein-Carem Jerusalem Israel Recruiting
Università di Torino Croce e Carle Cuneo Italy Recruiting
SODc Ematologia Azienda Ospedaliera Universitaria Careggi Florence Italy Recruiting
IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola Italy Recruiting
IRCCS San Raffaele Scientific Institute Milan Italy Recruiting
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz Gdansk Poland Recruiting

+ 5 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03328078 on ClinicalTrials.gov ↗ ← All trials in the USA