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NCT03328078 · ClinicalTrials.gov registry record · Phase 1

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)

A Phase 1 study of Relapsed Hematologic Malignancy and Refractory Primary Central Nervous System Lymphoma, sponsored by Curis.

Recruiting
Registry status
Phase 1
Development phase
152
Enrollment target
20
Study locations

NCT03328078 is a Phase 1 study of Relapsed Hematologic Malignancy and Refractory Primary Central Nervous System Lymphoma that is actively recruiting participants, run by Curis. The registered enrollment target is 152 participants, below the 383-participant average among 3 other Relapsed Hematologic Malignancy trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT03328078, a Phase 1 study of Relapsed Hematologic Malignancy and Refractory Primary Central Nervous System Lymphoma, is actively recruiting participants, sponsored by Curis.

RECRUITING
Registry status
Phase 1
Development phase
152 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Relapsed Hematologic Malignancy Refractory Primary Central Nervous System Lymphoma Refractory Hematologic Malignancy Relapsed Primary Central Nervous System Lymphoma

Interventions

  • DRUG Ibrutinib
  • DRUG Emavusertib

Study Locations (20)

New York

  • Roswell Park Comprehensive Cancer Center - Buffalo
  • Mt Sinai - New York
  • Columbia University Irving Medical Center - New York
  • Memorial Sloan Kettering Cancer Center - New York

California

  • City of Hope - Duarte
  • Providence St. John's Health Center - Santa Monica
  • UCLA Department of Medicine - Hematology/Oncology - Santa Monica

Arizona

  • St. Joseph's Hospital and Medical Center - Phoenix
  • Mayo Clinic - Phoenix

Connecticut

  • Smilow Cancer Hospital at Yale-New Haven - New Haven

Florida

  • Mayo Clinic - Jacksonville

Illinois

  • Northwestern Memorial Hospital - Chicago

Massachusetts

  • Dana Farber Cancer Institute - Boston

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 152 participants
Start Date 2017-12-28
Est. Completion 2026-10
Phase Phase 1

Sponsor

Curis

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03328078

The ClinicalTrials.gov registry entry for NCT03328078 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 383-participant average among 3 other Relapsed Hematologic Malignancy trials with a reported enrollment target (60% lower). The listed sponsor is Curis, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Relapsed Hematologic Malignancy appearing as the primary indexed condition, and to 2 interventions - of which Ibrutinib is the first listed.

NCT03328078 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT03328078 about?

NCT03328078 is a clinical study titled "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)". 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 complete...

What is the current status of trial NCT03328078?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 152 participants. The study started on 2017-12-28. Estimated completion is 2026-10.

What conditions does trial NCT03328078 study?

This clinical trial studies the following conditions: Relapsed Hematologic Malignancy, Refractory Primary Central Nervous System Lymphoma, Refractory Hematologic Malignancy, Relapsed Primary Central Nervous System Lymphoma.

What interventions are being tested in trial NCT03328078?

The interventions under investigation include: Ibrutinib (DRUG), Emavusertib (DRUG).

Who is sponsoring clinical trial NCT03328078?

This trial is sponsored by Curis, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03328078 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.