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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)
Must not have
- Alopecia
- Psoriasis, atopic dermatitis, or other autoimmune skin condition not requiring systemic treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 thru eot visit (28 days after last dose)
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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I am not currently receiving treatment for brain disease.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am experiencing hair loss.
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I have a skin condition like psoriasis but don't need strong medication for it.
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I have wounds from surgery or injury that have not healed.
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I have not had major surgery or serious injuries in the last 8 weeks.
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My arthritis is managed with just over-the-counter pain meds.
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I have had severe side effects from IL-2 therapy, such as heart issues or bleeding.
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I have vitiligo.
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My underactive thyroid is treated with hormone replacement.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Establish the maximum tolerated dose (MTD) and/or RP2D
Evaluate the safety and tolerability of AU-007
Secondary study objectives
Evaluate the preliminary anti-tumor activity of AU-007 alone, in combination with aldesleukin, and in combination with aldesleukin and avelumab in patients with unresectable locally advanced or metastatic cancer
Magnitude of PK changes in the blood after dosing determined by Half-life (T1/2) of AU-007
Magnitude of PK changes in the blood after dosing determined by area under the curve (AUC) of AU-007
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: AU-007 combined with an aldesleukin loading doseExperimental Treatment2 Interventions
AU-007 (Q2w) will be administered in combination with a single dose of aldesleukin with the initial AU-007 dose.
Group II: AU-007 combined with aldesleukin given concomitantlyExperimental Treatment2 Interventions
AU-007 will be administered in combination with aldesleukin, both administered Q2w.
Group III: AU-007 combined with aldesleukin and avelumab given concomitantlyExperimental Treatment3 Interventions
AU-007 and avelumab will be administered Q2w, with either a single loading dose or Q2w aldesleukin.
Group IV: 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
Avelumab
2017
Completed Phase 2
~2440
Aldesleukin
2012
Completed Phase 4
~1610
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 combined with aldesleukin and avelumab given concomitantly
- Group 2: AU-007 Monotherapy
- Group 3: AU-007 combined with an aldesleukin loading dose
- Group 4: 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.