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AU-007 is a novel investigational immune therapy being evaluated for the treatment of solid cancers.

 

The clinical trial is a first-in-human, open label, multi-centre Phase 1/2 study to evaluate the safety, tolerability and initial efficacy of AU-007 in patients with unresectable locally advanced or metastatic cancer. Eligible cancers include, but are not limited to, melanoma, renal cell carcinoma, Merkel cell carcinoma, non-small cell lung cancer, gastric cancer, gastro-esophageal cancer and urothelial cancer. Patients must either be ineligible for or have progressed on prior standard of care therapy. Potential study participants may be eligible if they have failed or progressed on anti-PD-1 or anti-PD-L1 therapy.

Does my patient qualify for this study?

Review the study criteria to see if your patient may be eligible for the AU-007 solid tumour study. All potential participants must complete screening at a study location prior to enrollment.

Study Details
 

Phase 1 consists of three dose escalation arms evaluating AU-007 either as a monotherapy, in combination with a single loading dose of subcutaneous, low dose human IL-2, or with both AU-007 and subcutaneous, low dose human IL-2 administered once every two weeks. The Phase 2 portion of the trial evaluates a dosing regimen selected from dose escalation for expansion in specified tumour types to further define the safety and initial efficacy of AU-007. For additional details, visit clinicaltrials.gov (NCT05267626).

Study Arms and Interventions
Arm
Intervention/Treatment

Experimental: AU-007 Monotherapy

AU-007 (Q2w) will be administered as a monotherapy in sequential ascending doses with each Dose Escalation Cohort.

Drug: AU-007

Monoclonal Antibody Targeting IL-2

Experimental: AU-007 combined with a subcutaneous, low dose of human IL-2

AU-007 (Q2w) will be administered at a fixed dose in combination with a single, subcutaneous, low dose of human IL-2 with the initial AU-007 dose. The subcutaneous, low dose human IL-2 dose will be escalated with each Dose Escalation Cohort.

Drug: AU-007

Monoclonal Antibody Targeting IL-2

Drug: Subcutaneous, low dose human IL-2

Experimental: AU-007 combined with subcutaneous, low dose human IL-2 given concomitantly

AU-007 will be administered at a fixed dose in combination with subcutaneous, low dose human IL-2, both administered Q2w. The subcutaneous, low dose human IL-2 dose will be escalated with each Dose Escalation Cohort.

Drug: AU-007

Monoclonal Antibody Targeting IL-2

Drug: Subcutaneous, low dose human IL-2

What is AU-007?

 

AU-007 is a computationally designed, human IgG1 monoclonal antibody. Preclinical studies have shown that it can bind human interleukin-2 (IL-2) with picomolar affinity and precisely block IL-2’s binding to CD25, without hindering IL-2’s binding to CD122/CD132. Through this unique mechanism of action, AU-007 has the potential to transform the IL-2 negative feedback loop into a positive one, tipping the balance toward immune activation and away from immune suppression. 

 

Learn more about AU-007 here.

Who can qualify?

Eligible participants can be males or females 18 years of age and older with refractory or resistant advanced solid tumour cancer who are interested in participating in a clinical trial to evaluate an investigational IL-2 therapeutic.

Where is the study?

The study is taking place at cancer care centres in Victoria and New South Wales. It is being led by seasoned oncologists with expertise in treating advanced cancers and conducting early phase cancer studies.

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