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Monoclonal Antibodies

APX005M + Doxorubicin for Soft Tissue Sarcoma

Phase 2

Waitlist Available

Led By Shaheer Khan, MD

Research Sponsored by Alexander Z. Wei, MD

Eligibility Criteria Checklist

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

Must have

Acceptable laboratory parameters: Absolute neutrophil count (ANC) ≥ 1,500/mm3, Hemoglobin ≥ 9 g/dL, Platelets ≥ 100,000/mm3, Creatinine ≤ 1.5 times upper limit of normal OR Calculated creatinine clearance > 45 mL/min, Total bilirubin ≤ upper limit of normal, AST/ALT ≤ 1.5 times upper limit of normal, Patients must have normal left ventricular systolic function, as demonstrated by a transthoracic echocardiogram or MUGA scan at screening, showing a normal left ventricular ejection fraction as defined by the laboratory performing the test

Disease must be locally advanced and unresectable or metastatic (that is, considered not amenable to curative surgery or radiation)

Must not have

Patients may not have any clinically serious, active infection requiring treatment with antibiotics within 14 days prior to registration

Patients may not have received prior treatment with: any anthracycline chemotherapy, CD40 agonist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether adding APX005M to doxorubicin can help treat advanced soft tissue sarcomas.

Who is the study for?

This trial is for adults with advanced soft tissue sarcoma that can't be removed by surgery or cured with radiation. They should have measurable disease, no prior anthracycline chemotherapy or CD40 agonist treatment, and must not have had certain heart conditions recently. Participants need to agree to use contraception and have acceptable blood counts and organ function.

What is being tested?

The study tests the combination of APX005M (an immunotherapy drug) with doxorubicin (a standard cancer treatment) in patients with advanced sarcomas. The goal is to see if adding APX005M improves the effectiveness of doxorubicin without causing unacceptable side effects.

What are the potential side effects?

Potential side effects include those commonly associated with chemotherapy like nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, as well as possible immune-related reactions from APX005M such as inflammation in various organs.

Eligibility Criteria

Inclusion Criteria

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

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My disease cannot be cured with surgery or radiation.

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My sarcoma is advanced and doxorubicin is a suitable treatment.

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My liposarcoma has a dedifferentiated component.

Exclusion Criteria

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

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I haven't needed antibiotics for a serious infection in the last 14 days.

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I have not been treated with anthracycline chemotherapy or CD40 agonist.

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I haven't had recent serious heart problems or procedures.

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I am not on high doses of steroids or any immunosuppressive drugs.

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I do not have any severe illnesses like heart failure or uncontrolled diabetes that would stop me from following the study's requirements.

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I have not had radiation therapy to my chest or pelvic area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective Response Rate

Secondary study objectives

Evaluation of Side Effects from APXO05M and Doxorubicin Treatment

Objective Response Rate (ORR)

Progression Free Survival

+1 more

Other study objectives

Changes in Immune Cell Infiltrates in Baseline and On-Study Biopsies

Expression of CD40 in Baseline Study Biopsies

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: Doxorubicin/APX005MExperimental Treatment2 Interventions

Patients will be treated with doxorubicin and APX005M in 21 day cycles. All patients receive the same treatment (there is no "placebo" arm). After completing 8 cycles of study treatment, patients without evidence of disease progression or unacceptable toxicity may continue treatment with APX005M alone. Doxorubicin will not be continued beyond cycle 8 due to the risk for cardiac toxicity from cumulative dosing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

2012

Completed Phase 3

~8030

APX005M

2017

Completed Phase 2

~390