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Anti-microtubule Agent
AP160-Complex for Advanced Cancer
Phase 1
Recruiting
Led By Matthew S. Block, M.D., Ph.D.
Research Sponsored by Mayo Clinic
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 from the start of the treatment until disease progression/recurrence, assessed up to 2 years
Awards & highlights
Study Summary
This trial tests if AP160-complex, a combination of chemo and immunotherapy, is safe & effective for treating advanced/metastatic solid tumors.
Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, including melanoma, who have already tried at least one systemic therapy. Participants must provide consent and a tissue sample for research. There's no limit to prior treatments but the cancer should be non-neurological and without curative options.Check my eligibility
What is being tested?
The trial tests the safety and optimal dose of AP160-complex, a new drug combining chemotherapy (nab-paclitaxel) and immunotherapy (STI-3031). It aims to see if this complex can better halt tumor growth compared to standard therapies in patients with advanced or metastatic solid tumors.See study design
What are the potential side effects?
Potential side effects may include those typical of chemotherapy such as nausea, hair loss, fatigue, increased risk of infection; plus immunotherapy-related reactions like allergies or autoimmune-like symptoms where the body attacks its own cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of the treatment until disease progression/recurrence, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of the treatment until disease progression/recurrence, assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximally tolerated dose (MTD)
Secondary outcome measures
Best response
Incidence of adverse events
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (AP160-complex)Experimental Treatment5 Interventions
Patients receive AP160-complex IV on study. Patients in the dose-escalation cohort undergo computed tomography/magnetic resonance imaging (MRI) scans, tissue biopsies, and collection of blood samples throughout the trial. Patients in the dose-expansion cohort undergo MRI scan during screening, collection of blood samples during screening and on study, and tissue biopsies throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,294 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,766,820 Total Patients Enrolled
Matthew S. Block, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester
5 Previous Clinical Trials
159 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My melanoma cannot be removed with surgery and is stage IV.I am not willing to use birth control during the study.I am willing to visit the hospital for follow-up after stopping the treatment.I have not fully recovered from my last surgery.I have had a severe reaction to immune therapy before.I am immunocompromised or HIV positive and on antiretroviral therapy.I still have side effects from my last chemotherapy.My nerve damage from previous treatments is mild or none.I am able to care for myself and perform daily activities.I haven't taken any cancer treatment or experimental drugs in the last 4 weeks.I have cancer that has spread to my brain.I am 18 years old or older.I have not used corticosteroids in the last 14 days.My side effects from previous immune treatments are mild or gone.There is a known treatment that could cure or extend my life.I haven't received anti-PD(L)1 therapy in the last 4 weeks.My hemoglobin level is at least 9.0 g/dL.I do not have nerve damage that affects my muscles.I haven't had any other cancer treatments in the last 3 years.My cancer shows minimal PDL1 presence, with at least 1% of cells testing positive.I have had at least one treatment for cancer that has spread.My cancer is advanced, cannot be cured by surgery or other treatments, and is not a brain tumor.My kidney function, measured by creatinine levels, is within the required range.I have had a heart attack in the last 6 months or have heart failure needing constant treatment.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have an autoimmune disease that needed strong medication in the last 2 years.My cancer progressed after treatment with anti-PD1/PDL1 in the advanced stage.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (AP160-complex)
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.
How likely is Treatment (AP160-complex) to harm or detriment patients?
"Our team at Power ranked the safety of Treatment (AP160-complex) with a 1 due to limited evidence from Phase 1 trials, indicating that its efficacy and safety still need to be established."
Answered by AI
Is this trial accepting applicants at the present time?
"According to records on clinicaltrials.gov, this trial is not currently recruiting patients; the study was posted on December 30th 2022 and last updated on the 8th of December that year. However, there are 2461 other medical trials actively searching for participants at this time."
Answered by AI
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