Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Aulos Bioscience, Inc.
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007 in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin given every 2 weeks (Q2w). Once the recommended phase 2 dose (RP2D) of AU-007 plus aldesleukin is determined, AU-007 plus aldesleukin will also be administered with avelumab.
Is the treatment AU-007 for advanced cancer promising?Yes, AU-007 is promising because gold-based treatments have shown to effectively kill cancer cells, reduce tumor growth, and prevent cancer from spreading. They can also enhance the effects of other cancer therapies, making them more effective.56101113
What safety data exists for AU-007 (Aldesleukin, Interleukin-2, IL-2, Proleukin) in advanced cancer treatment?The provided research does not contain specific safety data for AU-007 or its related names (Aldesleukin, Interleukin-2, IL-2, Proleukin). The articles focus on the safety profiles of other immunotherapies and treatments, such as immune checkpoint inhibitors and platinum drugs, but do not mention AU-007 or its equivalents. Therefore, additional sources or specific clinical trial data would be needed to answer this question accurately.89121415
What data supports the idea that AU-007 for Advanced Cancer is an effective drug?The available research does not provide specific data on the effectiveness of AU-007 for Advanced Cancer. Instead, it discusses other treatments for advanced cancers, such as chemotherapy and targeted therapies, which have shown some benefits like improved survival and quality of life. However, these studies do not mention AU-007 directly, so we cannot conclude its effectiveness based on the provided information.12347
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you must stop taking your current medications. However, you cannot take more than 10 mg per day of prednisone or other immune-suppressive drugs within 7 days before starting the study drug. Hormones for non-cancer-related conditions and bisphosphonates are allowed.
Eligibility Criteria
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.Inclusion Criteria
I do not have cancer spread to the lining of my brain or spinal cord.
I am not currently receiving treatment for brain disease.
Exclusion Criteria
I am experiencing hair loss.
I have a skin condition like psoriasis but don't need strong medication for it.
I have wounds from surgery or injury that have not healed.
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.
I have had severe side effects from IL-2 therapy, such as heart issues or bleeding.
I have vitiligo.
My underactive thyroid is treated with hormone replacement.
Treatment Details
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.
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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Tennessee OncologyNashville, TN
Carolina Biooncology InstituteHuntersville, NC
Mayo Clinic JacksonvilleJacksonville, FL
University of Utah - Huntsman Cancer CenterSalt Lake City, UT
More Trial Locations
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Who is running the clinical trial?
Aulos Bioscience, Inc.Lead Sponsor
References
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Gold(III) porphyrin 1a inhibited nasopharyngeal carcinoma metastasis in vivo and inhibited cell migration and invasion in vitro. [2010]A physiologically stable gold compound, gold(III) meso-tetraphenylporphyrin (gold-1a), has been shown to be effective in inducing apoptosis and prolonging the survival of hepatocellular carcinoma (HCC)-bearing rats as well as inhibiting the tumor growth of mice bearing nasopharyngeal carcinoma (NPC), neuroblastoma and colon carcinoma. In this study, we showed that gold-1a prolonged the survival of NPC metastasis-bearing mice and inhibited intrahepatic and lung metastasis. Histologically, gold-1a markedly reduced tumor microvessel formation. Consistently, in in vitro studies, gold-1a inhibited migration and invasion of C666-1 human NPC cells. The data strongly support the use of gold(III) compounds to treat cancer metastasis.
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