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RecruitingLast updated: 3 April 2024

This phase I/II trial is trying to understand how safe, tolerable and effective a targeted therapy (AU-007), with or without immunotherapy (aldesleukin), is in people with advanced or metastatic solid cancerA 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

Clinical summary

Summary

This is a rose escalation and expansion study for people with unresectable locally advanced or metastatic cancer who are 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 (administered every 2 weeks) in sequential escalation cohorts to define the recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD).

In Arm B, AU-007 (administered every two weeks) 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 (administered every 2 weeks) with an escalating single aldesleukin dose in sequential escalation cohorts.

In Arm C, AU-007 is evaluated in combination with aldesleukin both given every two weeks. 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 cancer types.

Conditions

This trial is treating patients with advanced solid cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

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Trial sponsor

Aulos Bioscience, Inc

Scientific 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

Eligibility

Inclusion

  • 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., ascites, pleural or pericardial effusion, organomegaly), are not eligible for enrolment.
  • 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

  • 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
  • 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 SAEs during prior IL-2 therapy (including but not limited to bowel perforation, GI bleeding, arrythmias, MI, 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

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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