Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05267626
Registration number
NCT05267626
Ethics application status
Date submitted
10/02/2022
Date registered
4/03/2022
Date last updated
31/05/2024
Titles & IDs
Public title
Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Ra Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer
Query!
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-2Ra Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer
Query!
Secondary ID [1]
0
0
CP-AU-007-01
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor
0
0
Query!
Metastatic Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - AU-007
Treatment: Drugs - Aldesleukin
Experimental: AU-007 Monotherapy - AU-007 (Q2w) will be administered as a monotherapy sequential ascending doses with each Dose Escalation Cohort
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
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
Treatment: Drugs: AU-007
Monoclonal Antibody Targeting IL-2
Treatment: Drugs: Aldesleukin
IL-2
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Evaluate the safety and tolerability of AU-007
Query!
Assessment method [1]
0
0
Measured by the frequency of DLTs (Dose limiting Toxicity) and safety profile
Query!
Timepoint [1]
0
0
Day 1 thru EOT visit (28 days after last dose)
Query!
Primary outcome [2]
0
0
Establish the maximum tolerated dose (MTD) and or/ recommended Phase 2 dose (RP2D)
Query!
Assessment method [2]
0
0
With AU-007 alone or in combination with aldesleukin measured by PK, PD, and Biomarkers
Query!
Timepoint [2]
0
0
Day 1 thru EOT visit (28 days after last dose)
Query!
Secondary outcome [1]
0
0
Magnitude of Pharmacokinetic changes in the blood after dosing determined by area under the curve (AUC) of AU-007
Query!
Assessment method [1]
0
0
The AUC of AU-007 will be measured at different timepoints after AU-007 administration
Query!
Timepoint [1]
0
0
Day 1 thru EOT visit (28 days after last dose)
Query!
Secondary outcome [2]
0
0
Magnitude of Pharmacokinetic changes in the blood after dosing determined by maximum concentration (Cmax) of AU-007
Query!
Assessment method [2]
0
0
The Cmax of AU-007 will be measured at different timepoints after AU-007 administration
Query!
Timepoint [2]
0
0
Day 1 thru EOT visit (28 days after last dose)
Query!
Secondary outcome [3]
0
0
Magnitude of Pharmacokinetic changes in the blood after dosing determined by time of maximum concentration (Tmax)
Query!
Assessment method [3]
0
0
The Tmax of AU-007 will be measured at different timepoints after AU-007 administration
Query!
Timepoint [3]
0
0
Day 1 thru EOT visit (28 days after last dose)
Query!
Secondary outcome [4]
0
0
Magnitude of Pharmacokinetic changes in the blood after dosing determined by Half-life (T1/2) of AU-007
Query!
Assessment method [4]
0
0
The T1/2 of AU-007 will be measured at different timepoints after AU-007 administration
Query!
Timepoint [4]
0
0
Day 1 thru EOT visit (28 days after last dose)
Query!
Secondary outcome [5]
0
0
Magnitude of cytokine changes in the blood after dosing
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Day 1 thru EOT visit (28 days after last dose)
Query!
Secondary outcome [6]
0
0
Magnitude of immunogenicity after dosing with AU-007 alone or in combination with aldesleukin
Query!
Assessment method [6]
0
0
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
Query!
Timepoint [6]
0
0
Day 1 thru EOT visit (28 days after last dose)
Query!
Secondary outcome [7]
0
0
Evaluate the preliminary anti-tumor activity of AU-007 alone or in combination with aldesleukin in patients with unresectable locally advanced or metastatic cancer
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Day 1 thru EOT visit (28 days after last dose)
Query!
Eligibility
Key inclusion criteria
Selected
- 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 study drug. 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
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
- 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1/Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/04/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/09/2025
Query!
Actual
Query!
Sample size
Target
136
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
Southside Cancer Care Centre - Miranda
Query!
Recruitment hospital [2]
0
0
Mark Oliphant Building - Bedford Park
Query!
Recruitment hospital [3]
0
0
Monash Health - Clayton
Query!
Recruitment hospital [4]
0
0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Query!
Recruitment hospital [5]
0
0
Austin Health - Heidelberg
Query!
Recruitment hospital [6]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment hospital [7]
0
0
Sunshine Hospital - Saint Albans
Query!
Recruitment postcode(s) [1]
0
0
2228 - Miranda
Query!
Recruitment postcode(s) [2]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [3]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [4]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [5]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [6]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [7]
0
0
3021 - Saint Albans
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
North Carolina
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Tennessee
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Texas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Utah
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Aulos Bioscience, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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)
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05267626
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
James Vasselli, MD
Query!
Address
0
0
Aulos Bioscience, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05267626
Download to PDF