Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
PRESERVE-009
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
1 other identifier
interventional
18
1 country
5
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2023
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2023
CompletedFirst Posted
Study publicly available on registry
May 15, 2023
CompletedStudy Start
First participant enrolled
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
April 9, 2026
April 1, 2026
3.1 years
May 3, 2023
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Dose Limiting Toxicity (DLT)
The number of subjects who have Dose limiting toxicity (DLT) as defined by protocol DLT criteria during the first cycle of study drug, AI-061, administration.
21 days after first treatment
Maximum Toxicity Dose (MTD)
Maximal tolerable dose (MTD), the study drug, AI-061, dose level that has two out of six subjects who have DLT.
21 day after first treatment
Recommended Phase II Dose (RP2D)
Recommended Phase II Dose (RP2D), the study drug, AI-061, dose level that is one level below MTD, or an intermediate dose level that below MTD and pre-specified in protocol. This dose level will be the RP2D.
21 days after first treatment
Incidence of treatment emergent adverse events (TEAE)
Incidence of treatment emergent adverse events (TEAE) according to CTCAE v5.0.
From the day with first treatment to 90 days after the last treatment.
Secondary Outcomes (5)
Cmax of AI-061
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.
The serum half-life of AI-061
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.
Objective Response Rate (ORR)
Up to 1 year.
Progression free survival (PFS)
Up to 1 year.
Overall survival (OS),
Up to 1 year.
Study Arms (3)
Level 1
EXPERIMENTALAI-061, 200 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year.
Level 2
EXPERIMENTALAI-061, 400 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year.
Level 3
EXPERIMENTALAI-061, 600 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year.
Interventions
A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC- 392 (Anti-CTLA-4) Antibodies.
Eligibility Criteria
You may qualify if:
- Patient is greater or 18 years of age on the day of signing the informed consent.
- All genders. Female subject with pregnancy potential must have a negative pregnancy test.
- Patient must have a performance status of less than or equal to 1 on the ECOG Performance Scale.
- Patients must have a histological or cytological diagnosis of solid tumors and have progressive locally advanced or metastatic disease.
- 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.
- Patient must have adequate organ function as indicated by the laboratory values. LDH less than or equal to ULN.
- Voluntary agreement to participate as evidenced by written informed consent.
- Female patient: agreement on contraceptive methods.
- Male patient: agreement on contraceptive methods.
- Life expectancy greater than or equal to 12 weeks.
You may not qualify if:
- 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.
- \. Patients who are currently enrolled in any other clinical trial testing an investigational agent or device, or with concurrent other systemic cancer therapeutics.
- \. 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.
- \. 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.
- \. 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.
- \. 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.
- \. Patients who are pregnant or breastfeeding.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OncoC4, Inc.lead
- OncoC4 AU Pty Ltdcollaborator
- Avance Clinical Pty Ltd.collaborator
Study Sites (5)
St. Vincent's Private Hospital
Darlinghurst, New South Wales, 2010, Australia
Mater Misericordiae Ltd.
Brisbane, Queensland, 4006, Australia
Tasman Oncology Research
Southport, Queensland, 4120, Australia
Cancer Research SA
Adelaide, South Australia, 5000, Australia
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 5042, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rohit Joshi, MD
Cancer Research South Australia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2023
First Posted
May 15, 2023
Study Start
July 11, 2023
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share