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 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CP-AU-007-01
• Study Type: interventional
• Target: 159
• Locations: 2 countries
• Sites: 18

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 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 was determined, (AU-007 Q2w plus a single loading dose of aldesleukin), AU-007 plus aldesleukin is also being administered with avelumab or nivolumab.

Conditions

Advanced Solid Tumor; Metastatic Cancer; Cutaneous Melanoma; Non-Small Cell Lung Cancer

Keywords

IL-2 CD25; IL-2Ra; Melanoma; Head and neck squamous cell carcinoma; Urothelial cancer; Gastric Cancer; Gastro-esophageal cancer; CD25; IL-2; NSCLC; Bladder Cancer; Merkel Cell Cancer; Proleukin; Immune Therapy; Immunotherapy; Cutaneous Squamous Cell Cancer; Cytokine; Anti-PD-L1; Non-small cell lung cancer; Clear cell renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Evaluate the safety and tolerability of AU-007

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

  Day 1 thru end of treatment (EOT) visit (28 days after last dose)

• Establish the maximum tolerated dose (MTD) and/or RP2D

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

  Day 1 thru EOT visit (28 days after last dose)

Secondary Outcomes (7)

• Magnitude of PK changes in the blood after dosing determined by area under the curve (AUC) of AU-007

  Day 1 thru EOT visit (28 days after last dose)

• Magnitude of PK changes in the blood after dosing determined by maximum concentration (Cmax) of AU-007

  Day 1 thru EOT visit (28 days after last dose)

• Magnitude of PK changes in the blood after dosing determined by time of maximum concentration (Tmax)

  Day 1 thru EOT visit (28 days after last dose)

• Magnitude of PK changes in the blood after dosing determined by Half-life (T1/2) of AU-007

  Day 1 thru EOT visit (28 days after last dose)

• Magnitude of cytokine changes in the blood after dosing

  Day 1 thru EOT visit (28 days after last dose)

Study Arms (5)

AU-007 Monotherapy

EXPERIMENTAL

AU-007 (Q2w) administered as a monotherapy sequential ascending doses with each Dose Escalation Cohort (Complete; no longer enrolling)

Drug: AU-007

AU-007 combined with a single dose of aldesleukin

EXPERIMENTAL

AU-007 (Q2w) administered in combination with a single dose of aldesleukin with the initial AU-007 dose.

Drug: AU-007; Drug: Aldesleukin

AU-007 combined with aldesleukin given concomitantly

EXPERIMENTAL

AU-007 administered in combination with aldesleukin, both administered Q2w (Complete; no longer enrolling)

Drug: AU-007; Drug: Aldesleukin

AU-007 plus aldesleukin in combination avelumab

EXPERIMENTAL

AU-007 and avelumab administered Q2w with a single dose of aldesleukin with the initial AU-007 dose

Drug: AU-007; Drug: Aldesleukin; Drug: Avelumab

AU-007 plus aldesleukin in combination with nivolumab

EXPERIMENTAL

AU-007 (Q2w) administered in combination with a single dose of aldesleukin with the initial AU-007 dose. Nivolumab will be administered Q4w.

Drug: AU-007; Drug: Aldesleukin; Drug: Nivolumab

Interventions

AU-007 DRUG

Monoclonal Antibody Targeting IL-2

AU-007 Monotherapy; AU-007 combined with a single dose of aldesleukin; AU-007 combined with aldesleukin given concomitantly; AU-007 plus aldesleukin in combination avelumab; AU-007 plus aldesleukin in combination with nivolumab

Aldesleukin DRUG

IL-2

AU-007 combined with a single dose of aldesleukin; AU-007 combined with aldesleukin given concomitantly; AU-007 plus aldesleukin in combination avelumab; AU-007 plus aldesleukin in combination with nivolumab

Avelumab DRUG

Monoclonal Antibody Targeting PD-L1

AU-007 plus aldesleukin in combination avelumab

Nivolumab DRUG

Monoclonal Antibody Targeting PD-1

AU-007 plus aldesleukin in combination with nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI
• Part 2 includes but is not limited to:
• Cutaneous melanoma 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
• Must have objective progression after receiving at least two cycles of prior doublet therapy (anti-PD-1/anti-CTLA-4 or anti-PD-1/anti-LAG-3)
• Radiographic progression ≥ 4 weeks prior to the first dose of study drug to rule out late response to most recent therapy. The requirement for documented radiologic progression may be waived after review by Medical Monitor (e.g., in the case of progression beyond 12 weeks after starting a doublet)
• LDH ≤ 2.5 x ULN
• NSCLC: Unresectable locally advanced or metastatic PD-L1-positive (tumor proportion score \[TPS\] ≥ 1%) NSCLC not harboring an activating EGFR mutation or ALK rearrangement and has progressed during or following treatment with an anti-PDx with or without platinum-based chemotherapy
• Part 3: NSCLC as described above
• Part 4: cutaneous melanoma
• Unresectable locally advanced or metastatic cutaneous melanoma that has progressed during or following treatment with an anti-PDx (unless ineligible for anti-PDx therapy)
• Patients with BRAF mutations must either be ineligible for or have refused a BRAF+MEK inhibitor
• Must have objective progression after receiving at least two cycles of prior doublet therapy (anti-PD-1/anti-CTLA-4 or anti-PD-1/anti-LAG-3).
• Radiographic progression ≥ 4 weeks prior to the first dose of study drug to rule out late response to most recent therapy. The requirement for documented radiologic progression may be waived after review by Medical Monitor (e.g., in the case of progression beyond 12 weeks after starting a doublet)

You may not qualify if:

• Patients with a history of known autoimmune disease with exceptions of
• Vitiligo
• Psoriasis, atopic dermatitis, or other autoimmune skin condition not requiring systemic treatment
• History of Graves' disease in patients now euthyroid for \> 4 weeks
• Hypothyroidism managed by thyroid hormone replacement
• Alopecia
• Arthritis managed without systemic therapy beyond oral nonsteroidal anti- inflammatory drugs
• Major surgery or traumatic injury within 3 weeks before first dose of AU-007
• Unhealed wounds from surgery or injury
• Treatment with \> 10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within the 7 days prior to the initiation of study drug. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed
• Prior anti-cancer therapy before the planned start of AU-007 as follows:
• Not recovered to baseline from toxicity of prior systemic cancer therapy(ies).
• Not recovered from toxicity of radiotherapy.
• 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.
• Patients who have experienced serious adverse events during prior IL-2 therapy (including but not limited to bowel perforation, gastrointestinal bleeding, arrythmias, myocardial infarction, repetitive seizures).

Sponsors & Collaborators

• Aulos Bioscience, Inc.: lead

Study Sites (18)

Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136-1002, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49503-2563, United States

RECRUITING

Minnesota Oncology and Hematology PA

Minneapolis, Minnesota, 55404-4526, United States

RECRUITING

Washington University

St Louis, Missouri, 63110-1010, United States

RECRUITING

Atlantic Healthcare System

Morristown, New Jersey, 07960, United States

RECRUITING

Carolina Biooncology Institute

Huntersville, North Carolina, 28078, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203-1619, United States

RECRUITING

Texas Oncology (Balcones) - SCRI

Austin, Texas, 78731-4214, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030-4000, United States

RECRUITING

START South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

RECRUITING

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

Southside Cancer Care Centre

Miranda, New South Wales, 2228, Australia

RECRUITING

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, 5042, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

RECRUITING

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, 3199, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Sunshine Hospital

Saint Albans, Victoria, 3021, Australia

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Melanoma; Carcinoma, Non-Small-Cell Lung; Diabetes Mellitus, Insulin-Dependent, 10; Squamous Cell Carcinoma of Head and Neck; Stomach Neoplasms; Urinary Bladder Neoplasms; Carcinoma, Merkel Cell; Carcinoma, Renal Cell

Interventions

aldesleukin; avelumab; Nivolumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Adenocarcinoma; Kidney Neoplasms; Kidney Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• James Vasselli, MD

  Aulos Bioscience, Inc.

  STUDY CHAIR

Central Study Contacts

Jim Vasselli, MD

CONTACT

(707) 758-6776; james@aulosbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 4, 2022
• Study Start: April 4, 2022
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): June 12, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (11); AU (7)