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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~day 1 thru eot visit (28 days after last dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 thru eot visit (28 days after last dose) for reporting.

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 more

Awards & 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

AU-007 (Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT05267626 — Phase 1 & 2
Cancer Research Study Groups: AU-007 combined with aldesleukin and avelumab given concomitantly, AU-007 Monotherapy, AU-007 combined with an aldesleukin loading dose, AU-007 combined with aldesleukin given concomitantly
AU-007 (Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05267626 — Phase 1 & 2
~28 spots leftby Aug 2025