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Protein Kinase Inhibitor

Emavusertib +/- Ibrutinib for CNS Lymphoma

Phase 1 & 2

Recruiting

Research Sponsored by Curis, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Part A1: Diagnosis of histopathologically confirmed B-cell hematological malignancy (as per the World Health Organization [WHO] 2016 classification; Swedow 2016); eligible subtypes include follicular lymphoma, MZL, DLBCL, mantle cell lymphoma, and WM/LPL without the urgent need for treatment hyperviscosity.

Cohort 3: Primary CNS Lymphoma (PCNSL) only. If the MYD88 mutation status is unknown at baseline, the lymphoma will be tested for MYD88 mutations.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24- 36 months

Awards & highlights

Study Summary

This trial will evaluate the safety and efficacy of emavusertib given orally as monotherapy or in combination with ibrutinib for patients with relapsed/refractory hematologic malignancies.

Who is the study for?

Adults over 18 with certain types of B-cell blood cancers that have come back or haven't responded to treatment. They should be relatively healthy otherwise, with a life expectancy of at least 3 months and able to perform daily activities with minimal assistance (ECOG ≤1). Specific cancer types include marginal zone lymphoma, activated B-cell type diffuse large B-cell lymphoma, primary central nervous system lymphoma, and others resistant to the drug ibrutinib.Check my eligibility

What is being tested?

The trial is testing emavusertib alone or combined with ibrutinib in patients whose blood cancers have relapsed or are refractory. It's an open-label study which means everyone knows what treatment they're getting. The goal is to see how safe it is and how well it works against these cancers.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system, issues from combining drugs like emavusertib and ibrutinib, general discomforts such as fatigue or digestive problems, changes in blood tests reflecting organ function, but specifics will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a type of B-cell blood cancer but don't urgently need treatment for thickened blood.

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I have primary CNS lymphoma and may need testing for the MYD88 mutation.

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I have NHL with a known myddosome mutation.

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I have been diagnosed with a specific type of B-cell NHL according to WHO 2016.

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I am fully active or can carry out light work.

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I have been diagnosed with marginal zone lymphoma.

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My condition is listed for ibrutinib treatment by NCCN.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24- 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24- 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24- 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Maximum tolerated dose (MTD) of emavusertib as a monotherapy and in combination with ibrutinib measured by dose-limiting toxicities (DLTs)

Part A: Recommended Phase 2 Dose (RP2D) of emavusertib as a monotherapy and in combination with ibrutinib based on overall tolerability data

Part A: To determine the safety and tolerability of emavusertib as a monotherapy and in combination with ibrutinib: dose-limiting toxicity (DLT)

+1 more

Secondary outcome measures

Part B: To estimate the blood-brain barrier penetration in CNS lymphoma patients

Pharmacokinetic (PK) profile of emavusertib and ibrutinib measured by AUC

Pharmacokinetic (PK) profile of emavusertib and ibrutinib measured by Cmax

+8 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Emavusertib (CA-4948) dose escalationExperimental Treatment1 Intervention

Part A1: Dose-level cohorts with up to approximately 6 patients each will be used to define the Maximum Tolerated Dose (MTD) for emavusertib.

Group II: Emavusertib (CA-4948) and ibrutinib dose expansionExperimental Treatment2 Interventions

In two PCNSL Expansion Cohorts (Part B), emavusertib in combination with ibrutinib will be administered in patients with PCNSL. In Cohort 1, emavusertib 100 mg BID will be administered with ibrutinib 560 mg QD consecutively in a 28-day cycle in approximately 6 to 9 patients. In Cohort 2, CA-4948 200 mg BID will be administered with ibrutinib in at least 9 patients.

Group III: Emavusertib (CA-4948) and ibrutinib dose escalationExperimental Treatment2 Interventions

Part A2: Evaluate escalating dose levels of oral emavusertib in combination with 560 mg daily (QD) of oral ibrutinib. The starting dose of emavusertib to be used in combination will be 200 mg twice a day (BID). It is anticipated that 12 to 20 patients at a potential dose level will be required to establish optimal combination dosing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ibrutinib

2012

Completed Phase 3

~1390

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Curis, Inc.Lead Sponsor

16 Previous Clinical Trials

1,034 Total Patients Enrolled

Media Library

CA-4948 (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03328078 — Phase 1 & 2

Hematologic Malignancies Research Study Groups: Emavusertib (CA-4948) and ibrutinib dose expansion, Emavusertib (CA-4948) dose escalation, Emavusertib (CA-4948) and ibrutinib dose escalation

Hematologic Malignancies Clinical Trial 2023: CA-4948 Highlights & Side Effects. Trial Name: NCT03328078 — Phase 1 & 2

CA-4948 (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03328078 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any additional reports that have utilized CA-4948?

"CA-4948 was first investigated in 2011 by the National Institutes of Health Clinical Center located at 9000 Rockville Pike. There are currently 97 completed studies and 155 active trials, some of which are taking place in Knoxville, Tennessee."

Answered by AI

Is this trial being conducted in multiple locales within the city?

"For this medical trial, University of Tennessee Medical Center (Knoxville, TN), Smilow Cancer Hospital at Yale-New Haven (New Haven, CT), and Hackensack University Medical Center (Hackensack, NJ) are participating alongside 4 other sites."

Answered by AI

What is the uppermost limit of individuals involved in this trial?

"This clinical trial necessitates the enrollment of 221 participants who meet its specified inclusion criteria. Participants can take part in this research from different sites, including University of Tennessee Medical Center in Knoxville and Smilow Cancer Hospital at Yale-New Haven in New Haven."

Answered by AI

What is the aim of this experiment?

"Curis Inc., the trial sponsor, has announced that Part B: To assess overall response rate (ORR) of emavusertib in combination with ibrutinib will be monitored over a 12 month period to track efficacy. Furthermore, ancillary objectives include observing the Tmax and Cmin values of both drugs as well as CA-4948's respective Trough plasma concentration (Cmin)."

Answered by AI

Is there room for additional participants in this experiment?

"According to clinicaltrials.gov, this research endeavour is actively seeking out participants. This trial was first advertised on 28th December 2017 and modified most recently on 16th November 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of CA-4948 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma

2017. "A Study of CA-4948 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03328078.

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