Trial Title:
Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
NCT ID:
NCT05858736
Condition:
Melanoma
Non Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
High Grade Serous Adenocarcinoma of Ovary
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Endometrial Cancer
Cervical Cancer
Renal Cell Carcinoma
Bladder Cancer
Esophageal Cancer
Gastric Cancer
Gastroesophageal-junction Cancer
Colorectal Cancer
Anal Cancer
Hepatocellular Carcinoma
Bile Duct Cancer
Conditions: Official terms:
Carcinoma
Endometrial Neoplasms
Squamous Cell Carcinoma of Head and Neck
Fallopian Tube Neoplasms
Anus Neoplasms
Bile Duct Neoplasms
Cystadenocarcinoma, Serous
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Three dose levels will be tested sequentially.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AI-061
Description:
A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC- 392 (Anti-CTLA-4) Antibodies.
Arm group label:
Level 1
Arm group label:
Level 2
Arm group label:
Level 3
Other name:
Anti-PD-1 and anti-CTLA-4 in 1:1 co-formulation
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).
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.
Criteria for eligibility:
Criteria:
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.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Vincent's Private Hospital
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Mater Misericordiae Ltd.
Address:
City:
Brisbane
Zip:
4006
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Vikram Jain, MD
Email:
Principal Investigator
Facility:
Name:
Tasman Oncology Research
Address:
City:
Southport
Zip:
4120
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Andrew Hill, MD
Email:
Principal Investigator
Facility:
Name:
Cancer Research SA
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Rohit Joshi, MD
Email:
Principal Investigator
Facility:
Name:
Southern Oncology Clinical Research Unit
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Not yet recruiting
Investigator:
Last name:
Ganessan Kitchenadasse, MD
Email:
Principal Investigator
Start date:
July 11, 2023
Completion date:
June 15, 2025
Lead sponsor:
Agency:
OncoC4, Inc.
Agency class:
Industry
Collaborator:
Agency:
OncoC4 AU Pty Ltd
Agency class:
Other
Collaborator:
Agency:
Avance Clinical Pty Ltd.
Agency class:
Industry
Source:
OncoC4, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05858736
