Emavusertib + Zanubrutinib for Chronic Lymphocytic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of combining two drugs, emavusertib and zanubrutinib, in treating chronic lymphocytic leukemia (CLL). Researchers aim to determine if adding emavusertib can enhance treatment outcomes for individuals already using zanubrutinib. The study includes two groups: one for participants who have had a partial response to zanubrutinib and another for those whose CLL returned after initially responding to the drug. Suitable candidates for this trial are those with CLL who are currently taking zanubrutinib and have either experienced a partial response or a recurrence of CLL. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that zanubrutinib is generally easy for people with chronic lymphocytic leukemia (CLL) to tolerate. Studies indicate it is safer compared to similar drugs. For example, patients taking zanubrutinib reported fewer heart-related side effects than those taking ibrutinib, another CLL medication.
When researchers combined emavusertib with ibrutinib (a drug similar to zanubrutinib), patients tolerated it well. This combination was safe for patients with a different type of cancer. Although emavusertib is still under study, these results suggest it might be safe when used with zanubrutinib.
Overall, current evidence suggests that both zanubrutinib and emavusertib are generally well-tolerated. However, since emavusertib is still being researched, some unknown risks may exist.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Emavusertib and Zanubrutinib for treating chronic lymphocytic leukemia (CLL) because they offer a novel approach compared to standard treatments like chemotherapy and other targeted therapies. Most CLL treatments focus on disrupting cancer cell growth, but Emavusertib is a unique investigational drug that targets specific cancer-related pathways, potentially offering more precise action against cancer cells. Zanubrutinib, a BTK inhibitor, is already known for its effectiveness, and when combined with Emavusertib, it may enhance the overall response in patients. This combination could be particularly beneficial for those who have not responded fully to Zanubrutinib alone, providing a new hope for better outcomes.
What evidence suggests that this trial's treatments could be effective for chronic lymphocytic leukemia?
Research shows that zanubrutinib effectively treats chronic lymphocytic leukemia (CLL), achieving high success rates, particularly in patients new to treatment or those who have relapsed. Additionally, studies on emavusertib, when combined with similar treatments, have shown promising results in shrinking tumors or stabilizing the disease for many patients. Emavusertib targets a protein called IRAK-4, which aids cancer cell survival, thereby improving patient outcomes. In this trial, participants in both Cohort 1 and Cohort 2 will receive a combination of emavusertib and zanubrutinib. This combination may enhance treatment effects, potentially leading to better control of CLL. Early studies suggest this approach could be promising for people with this type of leukemia.16789
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Chronic Lymphocytic Leukemia or other B-cell malignancies. Participants must have been on zanubrutinib for at least a year, have a life expectancy of more than 3 months, and be able to perform daily activities with minimal assistance. They should also have measurable disease but may not join if they still have standard treatment options available.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive one of two doses of emavusertib twice daily and an approved dose of zanubrutinib per label
Treatment Part B
Additional participants are enrolled in an expansion if pre-defined criteria for Part A are met, receiving one of two doses of emavusertib BID and an approved dose of zanubrutinib per label
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Emavusertib
- Zanubrutinib
Trial Overview
The study tests the effectiveness of combining Emavusertib with Zanubrutinib in treating CLL. It aims to see how well this combo works in patients who are already taking Zanubrutinib but need additional treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants in Cohort 2 include relapsed CLL participants who have directly progressed on zanubrutinib after a confirmed response (PR or better lasting 6 months or longer). In Part A, participants will receive one of two doses of emavusertib BID and an approved dose of zanubrutinib per label. In Part B, additional participants will be enrolled in an expansion if pre-defined criteria for Part A are met. Participants will receive one of two doses of emavusertib BID and an approved dose of zanubrutinib per label.
Participants in Cohort 1 include CLL participants who have been on zanubrutinib for at least 12 months and are currently in a partial response (PR) or partial response with lymphocytosis (PR-L) and measurable residual disease positive (MRD+). In Part A, participants will receive one of two doses of emavusertib twice daily (BID) and an approved dose of zanubrutinib per label. In Part B, additional participants will be enrolled in an expansion if pre-defined criteria for Part A are met. Participants will receive one of two doses of emavusertib BID and an approved dose of zanubrutinib per label.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Curis, Inc.
Lead Sponsor
Citations
Therapeutic Impact of Zanubrutinib in Chronic Lymphocytic ...
Conclusions: Zanubrutinib demonstrates favorable efficacy in CLL, achieving high ORR in both TN and R/R patients, with particularly durable ...
Analysis of genetic mutation profile and CNS ...
This study evaluates the molecular and pharmacokinetic (PK) data associated with responses to emavusertib + ibrutinib combination therapy in R/R PCNSL patients.
3.
curis.com
curis.com/wp-content/uploads/2024/05/TakeAim-Lymphoma-Clinical-Outcomes-ASH-2023-Poster.pdfTakeAim Lymphoma Clinical Outcomes ASH 2023 Poster
Majority of patients had decreases in tumor burden or stable disease over time. • The preliminary efficacy data of 16 evaluable patients in combination with ...
IRAK-4 inhibition: emavusertib for the treatment of ...
In a PCNSL xenograft model, treatment with 100mg/kg of the IRAK-4 kinase inhibitor emavusertib improved median survival by 68%, with 37.5% (n=3/ ...
5.
ad-hoc-news.de
ad-hoc-news.de/boerse/news/ueberblick/curis-advances-clinical-program-with-new-combination-therapy-trial/68494556Curis Advances Clinical Program with New Combination ...
The primary focus of this newly active study is to determine whether the combination therapy can deepen treatment responses or overcome ...
Zanubrutinib Safe, Effective in Real-World CLL/SLL Cohort
Cardiac adverse events were lower among patients taking zanubrutinib compared with ibrutinib in the real-world setting.
Emavusertib (CA-4948) in combination with ibrutinib ...
Conclusions: Emavusertib in combination with ibrutinib was well tolerated with an acceptable safety profile and promising efficacy in R/R PCNSL ...
Improved efficacy and safety of zanubrutinib versus ...
Zanubrutinib demonstrated improved ORR, PFS, and OS vs. ibrutinib and a more favorable safety profile in patients with R/R CLL/SLL in China.
9.
researchgate.net
researchgate.net/publication/391528921_Zanubrutinib_is_well_tolerated_and_effective_in_patients_with_CLLSLL_intolerant_of_ibrutinibacalabrutinib_updated_resultsZanubrutinib is well tolerated and effective in patients with ...
Of 67 efficacy-evaluable patients, 94% experienced disease control: 30% had a best response of stable disease and 64% had a partial or complete ...
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