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Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-07-11
Primary completion: 2024-12-31
Study completion finish: 2025-06-15
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05858736
Intervention or treatment
DRUG: AI-061
Conditions
- • Melanoma
- • Non Small Cell Lung Cancer
- • Head and Neck Squamous Cell Carcinoma
- • Fallopian Tube Cancer
- • Endometrial Cancer
- • Cervical Cancer
- • Renal Cell Carcinoma
- • Bladder Cancer
- • Esophageal Cancer
- • Gastric Cancer
- • Colorectal Cancer
- • Hepatocellular Carcinoma
- • High Grade Serous Adenocarcinoma of Ovary
- • Primary Peritoneal Carcinoma
- • Gastroesophageal-junction Cancer
- • Anal Cancer
- • Bile Duct Cancer
Find a site
Closest Location:
Tasman Oncology Research
Research sites nearby
Select from list below to view details:
Tasman Oncology Research
Southport, Queensland, Australia
Cancer Research SA
Adelaide, South Australia, Australia
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
St. Vincent's Private Hospital
Darlinghurst, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Level 1
| DRUG: AI-061
|
EXPERIMENTAL: Level 2
| DRUG: AI-061
|
EXPERIMENTAL: Level 3
| DRUG: AI-061
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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. | 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. | 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. | 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. | Up to 1 year. |
Overall survival (OS), | Overall survival (OS), the event is the time that all cause death occurs. | Up to 1 year. |
Frequently Asked Questions
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