top of page

I'm A

AU-007 Solid Tumour Study Patients Image.png

Are you living with advanced solid cancer?

If so, you may be interested in the AU-007 solid tumour study. Eligible participants include people diagnosed with unresectable locally advanced or metastatic cancer, including skin cancer, kidney cancer, Merkel cell carcinoma, non-small cell lung cancer, gastric cancer and bladder cancer. If you have tried and not benefited from anti-PD-1 or anti-PD-L1 therapy, you may still be eligible for the AU-007 study.

What is a clinical trial?

Clinical research studies (also known as “clinical trials” or “research studies”) explore the potential benefit of a medical treatment for a disease and illness. The AU-007 solid tumour study is a first-in-human Phase 1/2 trial that will look at how safe and tolerable AU-007 is in humans. AU-007 is a potential new immune therapy for the treatment of solid tumour cancers.

How do I know if I qualify?

Every clinical trial has inclusion and exclusion criteria. The AU-007 solid tumour study has its own requirements that you can review below. These guidelines can help you determine if you may be eligible for the study. If you think you could be eligible for this study, please contact a participating research centre and they can help schedule a screening test.

Study eligibility includes, but is not limited to:

You are a male or female over 18 years old

Have a selected solid tumour type and have progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment

Have tried anti-PD-1 or anti-PD-L1 therapy and that therapy has failed or hasn’t worked

Eligible participants CANNOT:

Have a history of known autoimmune disease*

Have major surgery or traumatic injury within 8 weeks before the first dose of AU-007

Have unhealed wounds from surgery or injury

Have had radiation therapy < 2 weeks before starting treatment with AU-007

*With the exception of vitiligo; psoriasis, atopic dermatitis, or other autoimmune skin condition not requiring systemic treatment; Graves' disease in patients now euthyroid for > 4 weeks; hypothyroidism managed by thyroid hormone replacement; alopecia; and arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.

Have received treatment with > 10 mg per day of immune-suppressive drugs within the 7 days prior to starting treatment with AU-007.

*Steroids for topical, ophthalmic, inhaled or nasal administration are allowed.

Have had prior therapy within the following timeframe before the planned start of AU-007 as follows:

Cytotoxic chemotherapy, small molecule inhibitors, radiation, interventional radiology procedure or similar investigational therapies: ≤ 2 weeks or 5 half-lives, whichever is shorter.

Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates or similar investigational therapies: ≤ 4 weeks.

Concurrent use of hormones either to maintain castrate levels of testosterone in patients with castration-sensitive prostate cancer or for non-cancer-related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable. Bisphosphonates are permitted.

Have had an inflammatory process that has not resolved for ≥ 4 weeks from the date of the first study dose of AU-007. Patients with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of duration.

Have a second primary invasive malignancy not in remission for ≥ 1 year.

Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ or any malignancy considered to be indolent and never required therapy, with the exception of indolent lymphomas.

Where is the study?

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

How does it work?

The Phase 1/2 trial is a two-part, open label, first-in-human study evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007, a computationally designed, human IgG1 monoclonal antibody.

bottom of page