Zanzalintinib + Eribulin for Soft Tissue Sarcoma

Recruiting at 1 trial location

Overseen By Mia C Weiss, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Washington University School of Medicine

Must not be taking: Oral anticoagulants, CYP inhibitors

Disqualifiers: Untreated brain metastases, Uncontrolled hypertension, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 24 months

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two drugs, eribulin and zanzalintinib, to determine if they work better together for treating certain types of advanced soft tissue sarcoma, a rare cancer affecting tissues like muscles and fat. Researchers aim to find out if this combination can help patients live longer without their cancer worsening compared to using eribulin alone. Suitable participants have a specific type of sarcoma that hasn't responded to one or more treatments and is causing ongoing issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain medications like oral anticoagulants, some complementary medicines, or certain investigational agents close to the start of the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found eribulin effective in treating advanced liposarcoma, a type of soft tissue cancer. It extended patients' lives compared to another drug. Eribulin is generally considered safe and is already used for this cancer type.

Research suggests that combining eribulin with zanzalintinib might be safe for patients. Although detailed safety information for this combination is not yet available, eribulin's approval for a similar condition provides some confidence in its safety. As this is an early-phase trial, the main goal is to ensure the combination's safety and determine the right dose. Participants might experience some side effects, but the trial will closely monitor and manage these. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Zanzalintinib and Eribulin for treating soft tissue sarcoma because it offers a new approach by combining two different mechanisms of action. Eribulin is a well-known chemotherapy drug that works by inhibiting cell division, while Zanzalintinib is a newer agent that targets specific kinases involved in tumor growth and survival. This combination aims to enhance the treatment effectiveness by attacking the cancer cells in multiple ways, potentially leading to better outcomes than current treatments like doxorubicin, which primarily use a single mechanism. Additionally, the oral administration of Zanzalintinib offers a more convenient option for patients compared to traditional intravenous chemotherapy.

What evidence suggests that this trial's treatments could be effective for soft tissue sarcoma?

Studies have shown that eribulin can help treat advanced soft tissue sarcoma, particularly liposarcoma, by extending patient survival compared to other treatments. One study found that 46.9% of patients with liposarcoma did not experience cancer progression for at least 12 weeks. This trial will evaluate the combination of eribulin with another drug, zanzalintinib, to determine if it can extend progression-free survival even further. This combination may also be more tolerable and effective than eribulin alone. Early results are promising, but further research is needed to confirm these benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

Mia C Weiss, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Adults with advanced liposarcoma or leiomyosarcoma who have measurable disease, good performance status, and adequate organ function. They must have tried at least one prior therapy but no more than two. Participants need to use effective contraception and cannot be pregnant or breastfeeding. Those with certain serious health conditions, recent major cardiovascular events, uncontrolled illnesses, or allergies to study drugs are excluded.

Inclusion Criteria

Measurable disease per RECIST 1.1

I am fully active or have some restrictions but can still carry out light work.

I agree to use birth control during and after the study as required.

Exclusion Criteria

Currently receiving any other investigational agents

I have been treated with zanzalintinib before.

Other conditions which, in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zanzalintinib and eribulin in 21-day cycles, with dose escalation to determine the maximum tolerated dose

24 months

Visits on Days 1 and 8 of each 21-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 years

What Are the Treatments Tested in This Trial?

Interventions

• Eribulin
• Zanzalintinib

Trial Overview The trial is testing the combination of Zanzalintinib and Eribulin versus Eribulin alone in patients with specific sarcomas. The goal is to see if this drug combo can extend the time patients live without their disease getting worse compared to historical data on Eribulin only.

How Is the Trial Designed?

Group I: Dose Level 2: Zanzalintinib + Eribulin Experimental Treatment 2 Interventions

Patients will receive zanzalintinib 60 mg by mouth once daily on Days 1 through 21 and eribulin intravenously on Days 1 and 8 of a 21-day cycle.

Group II: Dose Level 1 (starting dose): Zanzalintinib + Eribulin Experimental Treatment 2 Interventions

Patients will receive zanzalintinib 40 mg by mouth once daily on Days 1 through 21 and eribulin intravenously on Days 1 and 8 of a 21-day cycle.

Group III: Dose Level -1: Zanzalintinib + Eribulin Experimental Treatment 2 Interventions

Patients will receive zanzalintinib 20 mg by mouth once daily on Days 1 through 21 and eribulin intravenously on Days 1 and 8 of a 21-day cycle.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Exelixis

Industry Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Citations

1. withpower.com withpower.com/trial/phase-1-sarcoma-6-2025-c73c1

Zanzalintinib + Eribulin for Soft Tissue Sarcoma Eribulin has shown effectiveness in treating advanced liposarcoma, a type of soft tissue sarcoma, by improving overall survival compared to another drug, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06957431?cond=Cancer&aggFilters=funderType%3Aindustry%2CstudyType%3Aint

Study Details | Zanzalintinib Combined With Eribulin in ... The investigators hypothesize that the combination of eribulin and zanzalintinib will be tolerable and lead to improved progression-free survival (PFS) as ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.11577

Efficacy and safety of eribulin in the treatment of advanced ... The results originally stated: “10 out of 33 (30.3%) patients with L-type sarcomas had achieved PR and the median PFS was 2.67 months, 1 out of ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06957431/zanzalintinib-combined-with-eribulin-in-advanced-liposarcoma-and-leiomyosarcoma

Zanzalintinib Combined With Eribulin in Advanced ... The investigators hypothesize that the combination of eribulin and zanzalintinib will be tolerable and lead to improved progression-free ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9014307/

Efficacy of Eribulin in Soft Tissue Sarcomas - PMC The best results were found in the LPS group, with 15 patients (46.9%) being progression free at 12 weeks. This was followed by 12 (31.6%) in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11337792/

PMC - PubMed Central However, the objective response rate (ORR) ranges only from 5 to 20%, with a poor median progression-free survival (mPFS) of 4.2 months [3].