Brief Summary
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 advancedat a late stage, far along solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dosethe amount of medication taken 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.
Intervention / Treatment
- Drug: AU-007
- Drug: Aldesleukin
- Drug: Avelumab
Inclusion Criteria
- Measurable or non-measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI. In Cohort Expansion, patients with truly non-measurable only disease (e.g., ascitesa buildup of fluid in the abdomen, pleural or pericardial effusionabnormal fluid build-up in the pericardium, organomegaly), are not eligible for enrollment
- In Dose Escalation patients must have selected tumor types and have progressed after standard of care treatment, or be intolerant to treatment, or refused standard treatment
- Part 2 includes but is not limited to:
- Renal cell cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs progressing during or following at least two approved therapeutic regimens (e.g., small molecule inhibitors, anti-PDx therapy)
- Cutaneous melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body) that is either locally unresectable or metastatic:
- BRAF wild type: progressed after receiving PD-1 containing therapy with or without an anti-CTLA-4
- BRAF mutation: patients who refused BRAF+MEK inhibitor
- NSCLC: Unresectable locally advanced or metastatic PD-L1-positive (≥ 1%) NSCLC not harboring an activating EGFR mutation or ALK rearrangement and has progressed during or following treatment with an anti-PDx and platinum-based chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells (unless ineligible for platinum therapy)
- Part 3: NSCLC as described above
- Female patients of childbearing potential must have a negative serum or urine pregnancy test performed within 72 hours prior to the initiation of study drug administration. Female patients of childbearing potential must be willing to use two forms of contraception throughout the study, starting with Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening through 60 days after the last dose of study drug. Abstinence is acceptable if this is the established and the preferred contraception method for the patient
- Male patients with partners of childbearing potential must use barrier contraception from the time of consent through 60 days after discontinuation of study drug and must not donate sperm during this period. In addition, male patients should have their partners use contraception (as documented for female patients) for the same period of time
- Patients who have previously received an immune checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have checkpoint inhibitor immune-related toxicity resolved to either Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells ≤ 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous checkpoint inhibitor-related hypothyroidisma condition that occurs when the thyroid doesn't produce enough thyroid hormones, also known as underactive thyroid are eligible for the study regardless of grade resolution if well controlled on thyroid hormone replacement therapymedication that increase the levels of certain hormones in the body
- Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:
- No concurrent treatment for CNS disease (e.g., surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence, radiation, corticosteroidsa type of anti-inflammatory medication that is used to treat inflammation ≥ 10 mg prednisone/day or equivalent)
- No concurrent leptomeningeal disease or cord compression