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Trial record 1 of 1 for:    Aulos Bioscience
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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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ClinicalTrials.gov Identifier: NCT05267626
Recruitment Status : Recruiting
First Posted : March 4, 2022
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
Aulos Bioscience, Inc.

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)

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Metastatic Cancer Drug: AU-007 Drug: Aldesleukin Phase 1 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 4, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 31, 2024


Arm Intervention/treatment
Experimental: AU-007 Monotherapy
AU-007 (Q2w) will be administered as a monotherapy sequential ascending doses with each Dose Escalation Cohort
Drug: AU-007
Monoclonal Antibody Targeting IL-2

Experimental: AU-007 combined with an aldesleukin loading dose
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
Drug: AU-007
Monoclonal Antibody Targeting IL-2

Drug: Aldesleukin
IL-2

Experimental: AU-007 combined with aldesleukin given concomitantly
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
Drug: AU-007
Monoclonal Antibody Targeting IL-2

Drug: Aldesleukin
IL-2




Primary Outcome Measures :
  1. Evaluate the safety and tolerability of AU-007 [ Time Frame: Day 1 thru EOT visit (28 days after last dose) ]
    Measured by the frequency of DLTs (Dose limiting Toxicity) and safety profile

  2. Establish the maximum tolerated dose (MTD) and or/ recommended Phase 2 dose (RP2D) [ Time Frame: Day 1 thru EOT visit (28 days after last dose) ]
    With AU-007 alone or in combination with aldesleukin measured by PK, PD, and Biomarkers


Secondary Outcome Measures :
  1. Magnitude of Pharmacokinetic changes in the blood after dosing determined by area under the curve (AUC) of AU-007 [ Time Frame: Day 1 thru EOT visit (28 days after last dose) ]
    The AUC of AU-007 will be measured at different timepoints after AU-007 administration

  2. Magnitude of Pharmacokinetic changes in the blood after dosing determined by maximum concentration (Cmax) of AU-007 [ Time Frame: Day 1 thru EOT visit (28 days after last dose) ]
    The Cmax of AU-007 will be measured at different timepoints after AU-007 administration

  3. Magnitude of Pharmacokinetic changes in the blood after dosing determined by time of maximum concentration (Tmax) [ Time Frame: Day 1 thru EOT visit (28 days after last dose) ]
    The Tmax of AU-007 will be measured at different timepoints after AU-007 administration

  4. Magnitude of Pharmacokinetic changes in the blood after dosing determined by Half-life (T1/2) of AU-007 [ Time Frame: Day 1 thru EOT visit (28 days after last dose) ]
    The T1/2 of AU-007 will be measured at different timepoints after AU-007 administration

  5. Magnitude of cytokine changes in the blood after dosing [ Time Frame: Day 1 thru EOT visit (28 days after last dose) ]
  6. Magnitude of immunogenicity after dosing with AU-007 alone or in combination with aldesleukin [ Time Frame: Day 1 thru EOT visit (28 days after last dose) ]
    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

  7. Evaluate the preliminary anti-tumor activity of AU-007 alone or in combination with aldesleukin in patients with unresectable locally advanced or metastatic cancer [ Time Frame: Day 1 thru EOT visit (28 days after last dose) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Selected Inclusion Criteria:

  • Measurable or non-measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI.
  • 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
  • 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 AU-007. 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 AU-007 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 CTCAE 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

Exclusion Criteria:

  • 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 8 weeks before first dose of AU-007
  • Unhealed wounds from surgery or injury
  • Radiation therapy < 2 weeks prior to initiation of AU-007
  • 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 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05267626


Locations
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Australia, New South Wales
Southside Cancer Care Centre Recruiting
Miranda, New South Wales, Australia, 2228
Contact: Paul DeSouza    +61(02) 95539588    P.DeSouza@westernsydney.edu.au   
Australia, Victoria
Monash Health Recruiting
Clayton, Victoria, Australia, 3168
Contact: Sophia Frentzas    +61(03) 8572 2392    sophia.frentzas@monashhealth.org   
Austin Health Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Andrew Weickhardt    +61(03) 9496 9918    Andrew.WEICKHARDT@austin.org.au   
Sponsors and Collaborators
Aulos Bioscience, Inc.
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Responsible Party: Aulos Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT05267626    
Other Study ID Numbers: CP-AU-007-01
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aulos Bioscience, Inc.:
IL-2 CD25
IL-2Ra
Clear cell renal cell cancer
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
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Aldesleukin
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents