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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My disease cannot be cured with surgery or radiation.
Select...
My sarcoma is advanced and doxorubicin is a suitable treatment.
Select...
My liposarcoma has a dedifferentiated component.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
Evaluation of Side Effects from APXO05M and Doxorubicin Treatment
Objective Response Rate (ORR)
Progression Free Survival
+1 moreOther outcome measures
Changes in Immune Cell Infiltrates in Baseline and On-Study Biopsies
Expression of CD40 in Baseline Study Biopsies
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
~7940
APX005M
2017
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
Apexigen America, Inc.Industry Sponsor
11 Previous Clinical Trials
613 Total Patients Enrolled
Alexander Z. Wei, MDLead Sponsor
Apexigen, Inc.Industry Sponsor
11 Previous Clinical Trials
613 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have symptoms from brain metastases and if present, they are stable and untreated with no plans for immediate treatment.My disease cannot be cured with surgery or radiation.I do not have HIV or hepatitis A, B, or C.I haven't needed antibiotics for a serious infection in the last 14 days.I haven't had recent serious heart problems or procedures.My liposarcoma has a dedifferentiated component.I can care for myself and am fit for strong chemotherapy.I have not had a blood clot in the past month.I am not on high doses of steroids or any immunosuppressive drugs.I don't have active autoimmune diseases except for controlled asthma, allergies, vitiligo, type 1 diabetes, psoriasis, or hypothyroidism.I agree to use birth control or abstain from sex during and for 4 months after the study.I haven't had cancer treatment or experimental drugs in the last 3 weeks and any side effects are minimal.I have no other cancers except for certain treated ones or those not requiring treatment.I have not been treated with anthracycline chemotherapy or CD40 agonist.My sarcoma is advanced and doxorubicin is a suitable treatment.I am willing to undergo two tumor biopsies with minimal risk.I do not have any active blood clotting disorders.I have not had major surgery in the last 28 days.I do not have any severe illnesses like heart failure or uncontrolled diabetes that would stop me from following the study's requirements.I have not had radiation therapy to my chest or pelvic area.
Research Study Groups:
This trial has the following groups:- Group 1: Doxorubicin/APX005M
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the significance of this research?
"Presently, there are 387 studies involving APX005M being conducted in 1935 cities and 67 countries. The first trial for this drug was completed in 1997 by Alfacell. This initial study had 300 participants and reached Phase 3 of the approval process. In the years since 1997, 682 trials have been completed globally."
Answered by AI
How many individuals are being observed in this clinical trial?
"That is accurate. According to the most recent update on clinicaltrials.gov, this research study is looking for 32 individuals to participate at a single site. The posting went up on 3/20/2019 and was last edited on 11/12/2021."
Answered by AI
What are some common reasons why a doctor might prescribe APX005M?
"APX005M is an effective treatment for hodgkins lymphoma, non-hodgkins lymphoma, carcinomas, bronchogenic carcinomas, and neuroblastomas."
Answered by AI
Is APX005M deadly for human beings?
"While there is some evidence backing APX005M's safety from Phase 2 trials, these same studies failed to show any efficacy. Consequently, it received a score of 2."
Answered by AI
Are investigators looking for more participants at this time?
"Yes, the trial is still recruiting patients according to the information available on clinicaltrials.gov. The study was created on March 20th, 2019 and last updated on November 12th, 2021. They are looking for a total of 32 patients at 1 location."
Answered by AI
Are there other examples of research using APX005M?
"As of right now, there are a total of 387 clinical trials ongoing that are studying the effects of APX005M. Out of those, 120 studies are in Phase 3. Many of these investigations into APX005M's efficacy are based out of New york City, but there are 23776 locations running these sorts of tests worldwide."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Columbia University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
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