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)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Part A: To determine the safety and tolerability of emavusertib as a monotherapy and in combination with ibrutinib: dose-limiting toxicity (DLT) — 12 months
The number of participants with a dose-limiting toxicity (DLT) in the first treatment cycle - Part A: Maximum tolerated dose (MTD) of emavusertib as a monotherapy and in combination with ibrutinib measured by dose-limiting toxicities (DLTs) — 12 months
MTD determined by the highest dose level studied at which fewer than 2 out of 6 subjects (\<33%) experience a dose limiting toxicity. - Part A: Recommended Phase 2 Dose (RP2D) of emavusertib as a monotherapy and in combination with ibrutinib based on overall tolerability data — 12 months
RP2D selected based on overall tolerability data from all participants treated at different dose levels and will not exceed the MTD. - Part B: Overall Response Rate (ORR) in participants with R/R PCNSL — 18 months
- Part C: ORR in participants with R/R PCNSL — 18 months
Trial sites (45)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
📄 Imbruvica (ibrutinib) drug profile →More Curis, Inc. trials in Italy
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 Italy