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Monoclonal Antibodies
Batiraxcept + Paclitaxel for Uterine Cancer
Phase 1
Waitlist Available
Led By David G Mutch, M.D.
Research Sponsored by Washington University School of Medicine
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 through completion of follow-up (estimated to be 5 years and 27 weeks)
Awards & highlights
Study Summary
This trial tests a new drug for advanced uterine cancer. It includes a dose escalation and expansion phase, plus biopsy and metabolism testing. To identify potential response biomarkers, immunohistochemistry will be used.
Who is the study for?
This trial is for women or transgender men with a uterus, aged 18+, who have recurrent high-grade uterine cancer that's not treatable by standard methods. They must be relatively healthy, with specific blood counts and organ functions within normal ranges, and no severe heart disease or active infections. Participants need measurable cancer lesions and can't be pregnant; they must use contraception if possible.Check my eligibility
What is being tested?
The study tests the safety of AVB-500 (Batiraxcept) combined with Paclitaxel in patients with recurrent high-grade uterine cancer. It aims to understand how well patients tolerate this combination therapy.See study design
What are the potential side effects?
While the side effects are being studied, similar treatments often cause nausea, fatigue, hair loss due to chemotherapy (Paclitaxel), as well as potential allergic reactions. The exact side effects of AVB-500 will be determined during this trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 5 years and 27 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 5 years and 27 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and severity of treatment-emergent adverse events
Secondary outcome measures
Incidence of anti-drug antibodies (ADA)
Overall response rate (ORR)
Overall survival (OS)
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Paclitaxel + AVB-500Experimental Treatment2 Interventions
Patients will receive up to 9 21-day cycles of paclitaxel + AVB-500. Patients will receive AVB-500 via intravenous (IV) infusion at the assigned dose level on days 1, 8, and 15 of each cycle. Patients will receive IV paclitaxel at a dose of 175 mg/m^2 on day 1 of each cycle. After 3 cycles, patients will be assessed for disease response. Patients who have progression will not continue on treatment. Patients who have a partial response or stable disease will continue on treatment for another 3 cycles of paclitaxel + AVB-500 at the assigned dose. Patients will be assessed for response again at the end of 6 cycles and may continue on treatment if they have partial response (PR) or stable disease (SD). Up to 9 cycles of treatment with paclitaxel + AVB-500 may be given. At the end of the 9 cycles, patients with a SD or PR can continue on maintenance AVB-500 until progression. Patients with complete response will continue single agent AVB-500 as maintenance therapy until progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,944 Previous Clinical Trials
2,304,457 Total Patients Enrolled
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480 Patients Enrolled for Endometrial Cancer
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,328 Total Patients Enrolled
75 Trials studying Endometrial Cancer
73,374 Patients Enrolled for Endometrial Cancer
Aravive, Inc.Industry Sponsor
8 Previous Clinical Trials
588 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer that has spread to my brain.I have previously been treated with AVB-500.My blood tests for bone marrow and organ function are normal.My kidney function is within the required range.I have a wound, ulcer, or bone fracture that hasn’t healed.I do not have a history of serious heart conditions.I had cancer within the last 2 years but now show no signs of it.I have a history of or currently have a brain or spinal cord condition.My cancer has returned, is high-grade, and didn't respond well to platinum-based treatment.I have received targeted therapy for my dMMR, MSI-H, or HER2-altered tumor.My condition cannot be treated with surgery or radiation alone.I can take care of myself but might not be able to do heavy physical work.I have had severe gastrointestinal issues in the last 3 months.I have not had major surgery in the last 14 days.I have been treated with trastuzumab, pembrolizumab, or dostarlimab.I do not have an active hepatitis or ongoing serious infection.I haven't had chemotherapy, radiation, or immunotherapy in the last 4 weeks.I am a woman or a transgender man over 18 with a uterus.I do not have any uncontrolled illnesses.
Research Study Groups:
This trial has the following groups:- Group 1: Paclitaxel + AVB-500
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.
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