MelanomaPhase 1PRESERVE-009NCT05858736
Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
A Phase 1 study testing AI-061 in people with Melanoma and Non Small Cell Lung Cancer, run by OncoC4, Inc. at 5 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- AI-061
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesAustralia
- Study dates
- 11 Jul 2023to 31 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Cancer Research SA
Adelaide, South Australia, 5000
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 5042
Mater Misericordiae Ltd.
Brisbane, Queensland, 4006
St. Vincent's Private Hospital
Darlinghurst, New South Wales, 2010
Tasman Oncology Research
Southport, Queensland, 4120
About this study
Official 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
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).
Read the detailed description
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. Both CTLA-4 and PD-1 are known targets for immunotherapy. This Phase I study will test 3 fixed doses of AI-061 given as intravenous (IV) infusion, once every 21 days (q3w): 200 mg (consists of 100 mg ONC-392 and 100 mg AI-025), 400 mg and 600 mg. The target population is patient with advanced or metastatic solid tumors that progressed on standard care systemic therapy or intolerable to standard of care systemic therapy. The primary objective is to determine the maximum toxicity dose (MTD) or the Recommended Phase 2 dose (RP2D). The study design follows the classical 3+3 design for Phase 1 study that will enroll up to 18 subjects. The treatment will be terminated when patient has intolerable toxicity, or death, or disease progression, or complete of 17 cycles of treatment in approximate 1 year, whichever come first.
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, High Grade Serous Adenocarcinoma of Ovary, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- Being tested
- AI-061
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Fallopian Tube Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Renal Cell, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-061Drug
Also called Anti-PD-1 and anti-CTLA-4 in 1:1 co-formulation
A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC- 392 (Anti-CTLA-4) Antibodies.
| Study group | Role | What they receive |
|---|---|---|
| Level 1 | Experimental | AI-061, 200 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year. Receives: Drug: AI-061 |
| Level 2 | Experimental | AI-061, 400 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year. Receives: Drug: AI-061 |
| Level 3 | Experimental | AI-061, 600 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year. Receives: Drug: AI-061 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 21 days after first treatment
Incidence of treatment emergent adverse events (TEAE)
Incidence of treatment emergent adverse events (TEAE) according to CTCAE v5.0.
Measured: From the day with first treatment to 90 days after the last treatment.
Secondary outcomes (5)
Cmax of AI-061
The highest Serum concentration of AI-061 after IV infusion at cycle 1 and cycle 3 dosings from different timepoints after drug administration.
Measured: 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
To determine the drug concentration in serum samples that are taken in various timepoints during the treatment in order to calculate drug half life.
Measured: 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)
Objective Response Rate (ORR), evaluated by investigators on radiological images according to RECIST 1.1.
Measured: Up to 1 year.
Progression free survival (PFS)
Progression free survival (PFS), the event is the time that diseased progressed evaluated by investigators or death occurs.
Measured: Up to 1 year.
Overall survival (OS),
Overall survival (OS), the event is the time that all cause death occurs.
Measured: Up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start11 Jul 2023
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Three dose levels will be tested sequentially.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoC4, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OncoC4 AU Pty Ltd, Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Rohit Joshi, MD, Principal investigator, Cancer Research South Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858736
- Sponsor's protocol ID
- AI-061-AU-01
- Acronym
- PRESERVE-009
- Status last verified
- Sep 2026
- First submitted
- 3 May 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05858736
- Acronym / sponsor ID
- PRESERVE-009 / AI-061-AU-01
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, High Grade Serous Adenocarcinoma of Ovary, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- OncoC4, Inc.Industry (pharma, biotech, devices)
- Collaborators
- OncoC4 AU Pty Ltd, Avance Clinical Pty Ltd.
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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. Both CTLA-4 and PD-1 are known targets for immunotherapy. This Phase I study will test 3 fixed doses of AI-061 given as intravenous (IV) infusion, once every 21 days (q3w): 200 mg (consists of 100 mg ONC-392 and 100 mg AI-025), 400 mg and 600 mg. The target population is patient with advanced or metastatic solid tumors that progressed on standard care systemic therapy or intolerable to standard of care systemic therapy. The primary objective is to determine the maximum toxicity dose (MTD) or the Recommended Phase 2 dose (RP2D). The study design follows the classical 3+3 design for Phase 1 study that will enroll up to 18 subjects. The treatment will be terminated when patient has intolerable toxicity, or death, or disease progression, or complete of 17 cycles of treatment in approximate 1 year, whichever come first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three dose levels will be tested sequentially.
| Arm | Type | Receives |
|---|---|---|
| Level 1 | Experimental | Drug: AI-061AI-061, 200 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year. |
| Level 2 | Experimental | Drug: AI-061AI-061, 400 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year. |
| Level 3 | Experimental | Drug: AI-061AI-061, 600 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-061Also: Anti-PD-1 and anti-CTLA-4 in 1:1 co-formulationA 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC- 392 (Anti-CTLA-4) Antibodies. | Drug | Level 1, Level 2, Level 3 |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: 21 days after first treatment
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.
Maximum Toxicity Dose (MTD)
Time frame: 21 day after first treatment
Maximal tolerable dose (MTD), the study drug, AI-061, dose level that has two out of six subjects who have DLT.
Recommended Phase II Dose (RP2D)
Time frame: 21 days after first treatment
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.
Incidence of treatment emergent adverse events (TEAE)
Time frame: From the day with first treatment to 90 days after the last treatment.
Incidence of treatment emergent adverse events (TEAE) according to CTCAE v5.0.
5 secondary outcomes
Cmax of AI-061
Time frame: 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
Time frame: 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)
Time frame: Up to 1 year.
Progression free survival (PFS)
Time frame: Up to 1 year.
Overall survival (OS),
Time frame: Up to 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohit Joshi, MD principal investigator
Cancer Research South Australia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AI-061 in people with Melanoma and Non Small Cell Lung Cancer, run by OncoC4, Inc. at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: 21 days after first treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.