RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-04

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05267626

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI * 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 * 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 * 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 * Patients must have no more than 1 prior line of systemic therapy for unresectable locally advanced or metastatic disease. Neo-adjuvant and adjuvant therapy do not count as a prior line of therapy * 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 Screening through 60 days after the last dose of study drug (or 5 months after the last dose of study drug for patients receiving nivolumab). 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 Grade ≤ 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous checkpoint inhibitor-related hypothyroidism are eligible for the study regardless of grade resolution if well controlled on thyroid hormone replacement therapy * 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., surgery, radiation, corticosteroids ≥ 10 mg prednisone/day or equivalent) * No concurrent leptomeningeal disease or cord compression	* 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). * Inflammatory process that has not resolved for ≥ 4 weeks from the date of first study dose. Patients with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of duration * 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

Inclusion Criteria

Exclusion Criteria

* Patients must have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI
* 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
* 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
* 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
* Patients must have no more than 1 prior line of systemic therapy for unresectable locally advanced or metastatic disease. Neo-adjuvant and adjuvant therapy do not count as a prior line of therapy
* 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 Screening through 60 days after the last dose of study drug (or 5 months after the last dose of study drug for patients receiving nivolumab). 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 Grade ≤ 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous checkpoint inhibitor-related hypothyroidism are eligible for the study regardless of grade resolution if well controlled on thyroid hormone replacement therapy
* 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., surgery, radiation, corticosteroids ≥ 10 mg prednisone/day or equivalent)
* No concurrent leptomeningeal disease or cord compression

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

Contacts and Locations

Study Contact

Jim Vasselli, MD

CONTACT

(707) 758-6776

james@aulosbio.com

Principal Investigator

James Vasselli, MD

STUDY_CHAIR

Aulos Bioscience, Inc.

Study Locations (Sites)

START Midwest

Grand Rapids, Michigan, 49503-2563

United States

Carolina Biooncology Institute

Huntersville, North Carolina, 28078

United States

Tennessee Oncology

Nashville, Tennessee, 37203-1619

United States

MD Anderson Cancer Center

Houston, Texas, 77030-4000

United States

START South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229

United States

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: Aulos Bioscience, Inc.

James Vasselli, MD, STUDY_CHAIR, Aulos Bioscience, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-04

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2022-04-04

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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

Conditions

Quick Navigation

Study Overview

Description

Official Title

Quick Facts

Study ID

Participation Criteria

Contacts and Locations

Study Contact

Principal Investigator

Study Locations (Sites)

Collaborators and Investigators

Study Record Dates

Study Registration Dates

Study Record Updates

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms