Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05858736




Registration number
NCT05858736
Ethics application status
Date submitted
3/05/2023
Date registered
15/05/2023
Date last updated
6/09/2023

Titles & IDs
Public title
Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
Scientific title
Safety, Pharmacokinetics (PK) and Efficacy of AI-061, A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC-392 (Anti-CTLA-4) Antibodies in Advanced Solid Tumors: An Open-Label Phase 1 Study
Secondary ID [1] 0 0
AI-061-AU-01
Universal Trial Number (UTN)
Trial acronym
PRESERVE-009
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Non Small Cell Lung Cancer 0 0
Head and Neck Squamous Cell Carcinoma 0 0
High Grade Serous Adenocarcinoma of Ovary 0 0
Primary Peritoneal Carcinoma 0 0
Fallopian Tube Cancer 0 0
Endometrial Cancer 0 0
Cervical Cancer 0 0
Renal Cell Carcinoma 0 0
Bladder Cancer 0 0
Esophageal Cancer 0 0
Gastric Cancer 0 0
Gastroesophageal-junction Cancer 0 0
Colorectal Cancer 0 0
Anal Cancer 0 0
Hepatocellular Carcinoma 0 0
Bile Duct Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Bowel - Anal
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AI-061

Experimental: Level 1 - AI-061, 200 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year.

Experimental: Level 2 - AI-061, 400 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year.

Experimental: Level 3 - AI-061, 600 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year.


Treatment: Drugs: AI-061
A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC- 392 (Anti-CTLA-4) Antibodies.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Limiting Toxicity (DLT)
Timepoint [1] 0 0
21 days after first treatment
Primary outcome [2] 0 0
Maximum Toxicity Dose (MTD)
Timepoint [2] 0 0
21 day after first treatment
Primary outcome [3] 0 0
Recommended Phase II Dose (RP2D)
Timepoint [3] 0 0
21 days after first treatment
Primary outcome [4] 0 0
Incidence of treatment emergent adverse events (TEAE)
Timepoint [4] 0 0
From the day with first treatment to 90 days after the last treatment.
Secondary outcome [1] 0 0
Cmax of AI-061
Timepoint [1] 0 0
Frequent PK samplings in cycle 1 and cycle 3, pre-dose and post-dose samples in other cycles and End of Treatment. Up to 1 year.
Secondary outcome [2] 0 0
The serum half-life of AI-061
Timepoint [2] 0 0
Frequent PK samplings in cycle 1 and cycle 3, pre-dose and post-dose samples in other cycles and End of Treatment. Up to 1 year.
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Up to 1 year.
Secondary outcome [4] 0 0
Progression free survival (PFS)
Timepoint [4] 0 0
Up to 1 year.
Secondary outcome [5] 0 0
Overall survival (OS),
Timepoint [5] 0 0
Up to 1 year.

Eligibility
Key inclusion criteria
1. Patient is greater or 18 years of age on the day of signing the informed consent.

2. All genders. Female subject with pregnancy potential must have a negative pregnancy
test.

3. Patient must have a performance status of less than or equal to 1 on the ECOG
Performance Scale.

4. Patients must have a histological or cytological diagnosis of solid tumors and have
progressive locally advanced or metastatic disease.

5. Measurable disease as determined by RECIST v1.1 (either tumor lesion or lymph node
lesion or both): Tumor mass: Must be accurately measurable in at least 1 dimension
(longest diameter to be recorded) with a minimum size of: 10 mm by computed tomography
(CT) scan (CT scan slide thickness must be less than 5 mm). Or: 20 mm by chest X-ray
(if clearly defined and surrounded by aerated lung).

Malignant lymph nodes: greater than or equal to 15 mm in short axis when assessed by
CT scan (CT scan slice thickness must be <5 mm). The measurement should be two
dimensions at axial plane. The short axis should be in perpendicular to long diameter.

6. Patient must have adequate organ function as indicated by the laboratory values. LDH
less than or equal to ULN.

7. Voluntary agreement to participate as evidenced by written informed consent.

8. Female patient: agreement on contraceptive methods.

9. Male patient: agreement on contraceptive methods.

10. Life expectancy greater than or equal to 12 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have not recovered to NCI CTCAE v5.0 less than or equal toGrade 1 from an
adverse event (AE) due to cancer therapeutics except endocrinopathy or the
chemotherapy-associated peripheral neuropathy (motor or sensory) that has recovered to
CTCAE v5.0 less than or equal to Grade 2 will be allowed. The washout period for cancer
therapeutic drugs should be 21 days prior to the first AI-061 dose for chemotherapy,
radiation, or targeted therapy or 28 days prior to the first AI-061 administration for
monoclonal antibody therapy. Best supportive care, such as thyroxine, insulin, steroid
replacement treatment, blood transfusion, and therapy for non-cancer conditions are
allowed.

2. Patients who are currently enrolled in any other clinical trial testing an
investigational agent or device, or with concurrent other systemic cancer therapeutics.

3. Patients who are on chronic systemic steroid therapy at doses higher than 10 mg/day
prednisone or equivalent within 7 days before the first treatment.

4. Patients who have active brain metastases or leptomeningeal metastases. 5. Patients who
have an active infection requiring systemic IV antibiotics within 14 days prior to
administration of AI-061. Regular treatment of urinary tract infection (UTI) and/or topical
treatment are allowed.

6. Patients who, in the opinion of the treating Investigator, have a history or current
evidence of any condition, therapy, or laboratory abnormality that might confound the
results of the study, interfere with the patient's participation for the full duration of
the study or make study participation not in the best interest of the patient. The
investigator should discuss this with the Sponsor.

7. Patients with known psychiatric or substance abuse disorders that in the opinion of the
investigator, would interfere with cooperation with the requirements of the trial.

8. Patients who are pregnant or breastfeeding.

9. Patients with active autoimmune diseases that require immunosuppressant treatment other
than 10 mg per day or lower prednisone. Patients with inflammatory bowel disease or
myasthenia gravis will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/06/2025
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
St. Vincent's Private Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Mater Misericordiae Ltd. - Brisbane
Recruitment hospital [3] 0 0
Tasman Oncology Research - Southport
Recruitment hospital [4] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [5] 0 0
Southern Oncology Clinical Research Unit - Bedford Park
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4006 - Brisbane
Recruitment postcode(s) [3] 0 0
4120 - Southport
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
OncoC4, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
OncoC4 AU Pty Ltd
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Avance Clinical Pty Ltd.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
AI-061 is a co-formulation drug product (DP) consisting of 1:1 ratio mix of AI-025, an
anti-PD-1 antibody, and ONC-392, an anti-CTLA-4 antibody. This is a dose escalation study to
identify the maximum toxicity dose (MTD) or the recommended phase 2 dose (RP2D).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05858736
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rohit Joshi, MD
Address 0 0
Cancer Research South Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pan Zheng, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
2027516823
Fax 0 0
Email 0 0
pzheng@oncoc4.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05858736