What side effects are associated with this type of intervention?

Common treatments for Chronic Lymphocytic Leukemia (CLL) include antibody-drug conjugates (ADCs) like Zilovertamab Vedotin, BTK inhibitors (ibrutinib, acalabrutinib), BCL-2 inhibitors (venetoclax), and chemoimmunotherapy (FCR, BR). ADCs can cause side effects such as infusion reactions, cytopenias, and peripheral neuropathy. BTK inhibitors are associated with atrial fibrillation, hypertension, and increased risk of infections. Venetoclax can lead to tumor lysis syndrome, neutropenia, and gastrointestinal issues. Chemoimmunotherapy regimens like FCR and BR often result in myelosuppression, increased infection risk, and gastrointestinal symptoms.

What prior FDA approvals exist?

FDA-approved treatments for Chronic Lymphocytic Leukemia (CLL) include several targeted therapies. While specific antibody-drug conjugates (ADCs) like Zilovertamab Vedotin are not mentioned, other targeted agents such as Bruton tyrosine kinase (BTK) inhibitors (ibrutinib, acalabrutinib, zanubrutinib) and BCL-2 inhibitors (venetoclax) have been approved. These therapies target specific pathways in cancer cells, similar to the mechanism of ADCs. Additionally, combinations like venetoclax plus obinutuzumab and ibrutinib plus obinutuzumab have shown efficacy in treating CLL.

What other types of research exist?

Promising novel alternatives to Zilovertamab Vedotin for CLL patients include: 1) Acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, known for its efficacy and better tolerability compared to Ibrutinib. 2) Zanubrutinib, another BTK inhibitor, which has shown less cardiac toxicity and is undergoing regulatory review in the United States. 3) Venetoclax in combination with Obinutuzumab, which offers a fixed-duration treatment and has shown high rates of undetectable minimal residual disease (uMRD). These alternatives provide effective options with varying profiles of efficacy, tolerability, and treatment duration.

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Antibody-drug conjugate

Zilovertamab vedotin for Waldenstrom Macroglobulinemia

Phase 1

Waitlist Available

Research Sponsored by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medication called zilovertamab vedotin, which is given through a drip. It is aimed at patients with different types of blood cancers who have already tried other treatments. The medication works by attaching to cancer cells and delivering a substance that helps to destroy them.

Who is the study for?

Adults (≥18 years) with certain types of blood cancers that have progressed after treatment can join this trial. They must have measurable cancer, resolved side effects from previous treatments, and proper organ function. Pregnant or breastfeeding individuals, those with significant heart disease, CNS malignancies, uncontrolled infections, liver cirrhosis, or recent major surgery cannot participate.

What is being tested?

The study is testing Zilovertamab vedotin given intravenously to people with various hematological cancers like leukemia and lymphoma. It aims to assess the drug's safety and effectiveness at different doses in patients who've had prior treatments but need more due to progressing disease.

What are the potential side effects?

Potential side effects of Zilovertamab vedotin may include reactions at the infusion site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems. Organ-specific inflammation could also occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3.5 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

Maximum tolerated dose (MTD) of zilovertamab vedotin

Recommended Dosing Regimen (RDR)

Secondary study objectives

AUC of MMAE

AUC of total UC-961 antibody

Apparent terminal half-life (t½) of plasma concentration of zilovertamab vedotin

+34 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Zilovertamab vedotin Schedule 3: Q3/4WExperimental Treatment1 Intervention

Participants will be administered escalating doses of zilovertamab vedotin at 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, and 2.25 mg/kg IV on Day 1, 8, and 15 of repeated 21-day cycles (Q3/4W).

Group II: Zilovertamab vedotin Schedule 2: Q2/3WExperimental Treatment1 Intervention

Participants will be administered escalating doses of zilovertamab vedotin at 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, and 2.25 mg/kg IV on Day 1 and 8 of repeated 21-day cycles (Q2/3W).

Group III: Zilovertamab vedotin Schedule 1: Q1/3WExperimental Treatment1 Intervention

Participants will be administered escalating doses of zilovertamab vedotin at 0.50, 1.00, 1.50, 2.25, 2.50, 2.75, and 3.00 mg/kg IV on Day 1 of repeated 21-day cycles (Q1/3W).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zilovertamab vedotin

2019

Completed Phase 1

~100

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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

The most common treatments for Chronic Lymphocytic Leukemia (CLL) include targeted therapies and antibody-drug conjugates (ADCs). Targeted therapies, such as Bruton tyrosine kinase (BTK) inhibitors (e.g., ibrutinib, acalabrutinib) and BCL2 inhibitors (e.g., venetoclax), work by interfering with specific proteins that promote cancer cell survival and proliferation. ADCs, like Zilovertamab Vedotin, combine an antibody specific to cancer cells with a cytotoxic drug, delivering the drug directly to the cancer cells and minimizing damage to healthy cells. This targeted approach is crucial for CLL patients as it offers more effective treatment with potentially fewer side effects compared to traditional chemotherapy. Other treatments include monoclonal antibodies (e.g., rituximab, obinutuzumab) that target specific antigens on cancer cells, and chemoimmunotherapy, which combines chemotherapy with immunotherapy to enhance the immune system's ability to fight cancer.

Targeted therapy in the treatment of chronic lymphocytic leukemia: facts, shortcomings and hopes for the future.New angles of attack in the fight against chronic lymphocytic leukemia: the advent of novel non-chemotherapeutic agents.