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Skin and Connective Tissue Diseases

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Stomach Neoplasms

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Carcinoma, Merkel Cell

Neoplasms, Second Primary

Neoplastic Processes

Stomach Cancer

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Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Merkel Cell Carcinoma

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Aldesleukin

Immunomodulating Agents

Immunoglobulins

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

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

AU-007 (Q2w) will be administered at a fixed dose in combination with a single dose of aldesleukin with the initial AU-007 dose. The aldesleukin dose will be escalated with each Dose Escalation Cohort

AU-007 will be administered at a fixed dose in combination with a aldesleukin, both administered Q2w. The aldesleukin dose will be escalated with each Dose Escalation Cohort

AU-007

John Powderly, MD

Meredith McKean

George Blumenschein

Drew Rasco

Siwen Hu-Lieskovan

Paul DeSouza

Elizabeth Ahern

Andrew Weickhardt

Andrew Haydon, MD

Catherine Oakman

James Vasselli, MD

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)

This is a first in human, multicenter, open-label Phase 1-2 study evaluating the safety, tolerability, and initial efficacy of AU-007 with or without aldesleukin, in patients with unresectable locally advanced or metastatic cancer. Patients must either be ineligible for or have progressed on prior standard of care therapy. Phase 1 consists of 3 escalation Arms, each starting with a single 1+2 escalation cohort followed by 3+3 escalation cohorts to define the recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD). The study begins in Arm A evaluating escalating doses of AU-007 (Q2w) in sequential escalation cohorts to define the recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD). In Arm B, AU-007 (Q2w) is evaluated in combination with a single dose of aldesleukin given with the first AU-007 dose. AU-007 is administered at a fixed dose (Q2w) with an escalating single aldesleukin dose in sequential escalation cohorts. In Arm C, AU-007 is evaluated in combination with aldesleukin both given Q2w. AU-007 will be administered at a fixed dose with an escalating dose of aldesleukin in each sequential Arm C escalation cohort. The Phase 2, cohort expansion portion of the study consists of three expansion Arms evaluating the initial efficacy of the RP2D from corresponding dose escalation Arms A, B, and C in selected solid tumor types. Initially, melanoma and renal cell cancer will be evaluated in each Arm. Other eligible cancers include but not limited to Merkel Cell Carcinoma, non-small cell lung cancer and urothelial cancer.

Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

Measured by the frequency of DLTs (Dose limiting Toxicity) and safety profile

With AU-007 alone or in combination with aldesleukin measured by PK, PD, and Biomarkers

The AUC of AU-007 will be measured at different timepoints after AU-007 administration

The Cmax of AU-007 will be measured at different timepoints after AU-007 administration

The Tmax of AU-007 will be measured at different timepoints after AU-007 administration

The T1/2 of AU-007 will be measured at different timepoints after AU-007 administration

Assessed by summarizing the number of patients who develop detectable anti-drug antibodies (ADAs) at different timepoints after AU-007 alone or in combination with aldesleukin

Clinical anti-tumor activity will be evaluated using conventional Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and modified RECIST v1.1.

Aulos Bioscience, Inc.

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Etoposide

Carboplatin

Etoposide phosphate

Enzyme Inhibitors

Conventional radical radiotherapy in this trial means that those patients with microscopic disease receive a dose of 50Gy using daily incremental fractions of 2Gy over 25 fractions and those with macroscopic disease receive 54Gy in 27 fractions.

During radiotherapy: Carboplatin (AUC2) commences on day 1 of radiation and is repeated at weekly intervals on days 8, 15, 22 and 29 (of radiation).

After radiotherapy: 3 weeks after completing radiotherapy, 3 cycles of 3 weekly carboplatin (AUC4.5) intravenously on day 1.

After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3

Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions

Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions

Radiotherapy

Michael Poulsen

A Phase II Study designed to evaluate the efficacy of Chemo-Radiotherapy in achieving loco-regional control in patients with Merkel Cell Carcinoma (MCC) of the skin. Patients will undergo PET scans to assist in staging and planning the patient's treatment as well as assessing response at the conclusion of treatment.

Merkel Positron Emission Tomography (PET) Protocol

A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin

Trans Tasman Radiation Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer	NCT05267626	Advanced Solid ... Metastatic Canc...	AU-007 Aldesleukin	18 Years -	Aulos Bioscience, Inc.
Merkel Positron Emission Tomography (PET) Protocol	NCT01013779	Merkel Cell Car...	Carboplatin Etoposide Radiotherapy	18 Years -	Trans Tasman Radiation Oncology Group

Spots Global Cancer Trial Database for merkel cell cancer