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Monoclonal Antibody
AU-007 for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Aulos Bioscience, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- No concurrent leptomeningeal disease or cord compression
- No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids ≥ 10 mg prednisone/day or equivalent)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 thru eot visit (28 days after last dose)
Awards & highlights
Study Summary
This trial is testing a new drug, AU-007, to see if it is safe and effective in treating people with advanced solid tumors.
Who is the study for?
This trial is for adults with advanced solid tumors who've tried standard treatments without success, can't tolerate them, or have refused them. They must not be pregnant and agree to use contraception. Those previously treated with immune checkpoint inhibitors need resolved side effects except controlled hypothyroidism.Check my eligibility
What is being tested?
The study tests AU-007 alone or combined with aldesleukin in patients with unresectable locally advanced or metastatic cancer. It's a Phase 1/2 trial assessing safety, tolerability, and initial effectiveness of the drugs administered every two weeks.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to monoclonal antibody therapy (like AU-007) and cytokine treatment (aldesleukin), which could range from mild allergic responses to more severe organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have cancer spread to the lining of my brain or spinal cord.
Select...
I am not currently receiving treatment for brain disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 thru eot visit (28 days after last dose)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 thru eot visit (28 days after last dose)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Establish the maximum tolerated dose (MTD) and or/ recommended Phase 2 dose (RP2D)
Evaluate the safety and tolerability of AU-007
Secondary outcome measures
Evaluate the preliminary anti-tumor activity of AU-007 alone or in combination with aldesleukin in patients with unresectable locally advanced or metastatic cancer
Magnitude of Pharmacokinetic changes in the blood after dosing determined by Half-life (T1/2) of AU-007
Magnitude of Pharmacokinetic changes in the blood after dosing determined by area under the curve (AUC) of AU-007
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: AU-007 combined with an aldesleukin loading doseExperimental Treatment2 Interventions
AU-007 (Q2w) will be administered at a fixed dose in combination with a single dose of aldesleukin with the initial AU-007 dose. The aldesleukin dose will be escalated with each Dose Escalation Cohort
Group II: AU-007 combined with aldesleukin given concomitantlyExperimental Treatment2 Interventions
AU-007 will be administered at a fixed dose in combination with a aldesleukin, both administered Q2w. The aldesleukin dose will be escalated with each Dose Escalation Cohort
Group III: AU-007 MonotherapyExperimental Treatment1 Intervention
AU-007 (Q2w) will be administered as a monotherapy sequential ascending doses with each Dose Escalation Cohort
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
2012
Completed Phase 4
~1620
Find a Location
Who is running the clinical trial?
Aulos Bioscience, Inc.Lead Sponsor
James Vasselli, MDStudy ChairAulos Bioscience, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am experiencing hair loss.I haven't taken more than 10 mg of prednisone or similar drugs in the last week.I have had an ongoing inflammation for more than 4 weeks.My brain metastases have been treated and I've had no symptoms for over 14 days.I still have side effects from previous cancer treatments.I have a skin condition like psoriasis but don't need strong medication for it.I have had another cancer, but it's been in remission for over a year, or it was a minor type that didn't need treatment.I have wounds from surgery or injury that have not healed.I have had cancer treatment before starting AU-007.I am a male and will use contraception, and ensure my partner does too, while on AU-007 and for 60 days after.I have not had major surgery or serious injuries in the last 8 weeks.My arthritis is managed with just over-the-counter pain meds.My cancer can be measured or seen on scans.I am still experiencing side effects from my recent radiotherapy.I have had severe side effects from IL-2 therapy, such as heart issues or bleeding.My cancer has worsened after standard treatment, or I cannot tolerate or refused it.I had immune therapy side effects, but they're mostly gone or treated, except for thyroid issues which are under control.I am using hormones for prostate cancer or other conditions, and may be taking bisphosphonates.I do not have cancer spread to the lining of my brain or spinal cord.I am not pregnant and agree to use two forms of birth control or practice abstinence during the study.I had Graves' disease but have been stable without symptoms for over 4 weeks.I have vitiligo.I am not currently receiving treatment for brain disease.My underactive thyroid is treated with hormone replacement.
Research Study Groups:
This trial has the following groups:- Group 1: AU-007 Monotherapy
- Group 2: AU-007 combined with an aldesleukin loading dose
- Group 3: AU-007 combined with aldesleukin given concomitantly
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.
Is enrollment for this research project currently available to participants?
"As evidenced by the clinicaltrials.gov listing, this research endeavour is actively enrolling participants. The study was initially posted on April 4th 2022 and recently updated on November 28th 2022."
Answered by AI
How many locations have been identified for the execution of this trial?
"Four medical institutions are currently enrolling patients in this trial, including Tennessee Oncology in Nashville, START South Texas Accelerated Research Therapeutics in Grand Rapids and Carolina Biooncology Institute. Additionally, there is representation from other locations as well."
Answered by AI
What is the recruitment number of participants for this trial?
"To ensure that the trial is adequately powered, Aulos Bioscience Inc. requires 69 participants who meet the criteria for inclusion. Enrollment will take place across two sites: Tennessee Oncology in Nashville and START South Texas Accelerated Research Therapeutics situated in Grand Rapids."
Answered by AI
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