What side effects are associated with this type of intervention?

Common treatments for Diffuse Large B-Cell Lymphoma (DLBCL) include chemotherapy regimens such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Side effects of these treatments can include myelosuppression (leading to increased risk of infection), nausea, vomiting, hair loss, fatigue, and cardiotoxicity. For investigational treatments like EZH1/2 inhibitors (e.g., MAK683), side effects may include gastrointestinal disturbances, fatigue, and hematologic toxicities, although specific data on MAK683 is still being evaluated in clinical trials.

What prior FDA approvals exist?

The FDA has approved several treatments for Diffuse Large B-Cell Lymphoma (DLBCL). These include traditional chemotherapy regimens like R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) and targeted therapies such as CAR-T cell therapies (e.g., axicabtagene ciloleucel and tisagenlecleucel). Additionally, the FDA has approved monoclonal antibodies like polatuzumab vedotin and tafasitamab, as well as small molecule inhibitors like ibrutinib. While specific information on EZH1/2 inhibitors like MAK683 is limited, these approvals highlight the range of therapeutic strategies available for DLBCL.

What other types of research exist?

E7123 is a promising novel alternative for DLBCL patients. It has shown effectiveness in both in vitro and in vivo studies, with a unique mechanism of action compared to current therapies. Further preclinical evaluation is supported.

← Back to Search

Other

MAK683 for Diffuse Large B-Cell Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Relapsed or refractory diffuse large B cell lymphoma with measurable disease as determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014)

Advanced or recurrent/metastatic solid tumor, including nasopharyngeal carcinoma, castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma and sarcoma, with measurable disease as determined by RECIST 1.1.

Must not have

Symptomatic central nervous system (CNS) involvement which are neurologically unstable or requiring increasing doses of steroids to control

B-cell lymphoma patients who have received prior allogeneic stem cell transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing MAK683, a new drug, in patients with advanced cancers that haven't responded to other treatments. The study aims to find the safest dose and see if the drug can shrink or stop tumor growth.

Who is the study for?

This trial is for adults with advanced cancers like Diffuse Large B-Cell Lymphoma or solid tumors without standard treatment options left. Participants should be fairly active and able to care for themselves (ECOG 0-2) and have measurable disease. They can't join if they've had certain recent cancer treatments, unstable brain involvement, a prior stem cell transplant, or blood, liver, and kidney values outside specific ranges.

What is being tested?

The study tests MAK683's safety and effectiveness in treating advanced malignancies. It aims to find the highest dose patients can tolerate without severe side effects (MTD) and suggest a phase 2 dose (RP2D), while also studying how the body processes the drug.

What are the potential side effects?

While not explicitly listed here, potential side effects of MAK683 may include typical reactions seen with cancer therapies such as fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding tendencies, liver function alterations, and possibly others based on its mechanism of action.

Eligibility Criteria

Inclusion Criteria

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

Select...

My large B cell lymphoma has returned or didn't respond to treatment, and it can be measured.

Select...

My cancer has spread or returned and can be measured by scans.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My brain or spinal cord cancer symptoms are getting worse, needing more medication.

Select...

I have B-cell lymphoma and have had a stem cell transplant from a donor.

Select...

I do not have any cancer other than the one being treated in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities (DLTs)

Safety and tolerability

Secondary study objectives

Area Under the Plasma Concentration (AUC) Time Curve of MAK683

Tromethamine

Half-Life of MAK683

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase I - AllExperimental Treatment1 Intervention

advanced stage (relapsed/refractory or recurrent/metastatic) malignancy limited to the following malignancies; DLBCL, nasopharyngeal carcinoma, gastric cancer, ovarian cancer, prostate cancer and sarcoma.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Diffuse Large B-Cell Lymphoma (DLBCL) treatments often target pathways critical for cancer cell growth and survival. Chemotherapy kills rapidly dividing cells, including cancer cells, while immunotherapy enhances the immune system's ability to recognize and destroy these cells. Targeted therapies, such as BTK inhibitors, block specific proteins essential for cancer cell growth. EZH1/2 inhibitors like MAK683 target epigenetic regulators involved in gene expression, potentially reprogramming cancer cells to a less aggressive state. This approach is significant for DLBCL patients as it offers a novel mechanism to combat the disease, potentially improving treatment outcomes.