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Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors (PRESERVE-009)

Primary Purpose

Melanoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
AI-061
Sponsored by
OncoC4, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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.

Sites / Locations

  • St. Vincent's Private Hospital
  • Mater Misericordiae Ltd.Recruiting
  • Tasman Oncology ResearchRecruiting
  • Cancer Research SARecruiting
  • Southern Oncology Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Level 1

Level 2

Level 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
Incidence of treatment emergent adverse events (TEAE)
Incidence of treatment emergent adverse events (TEAE) according to CTCAE v5.0.

Secondary Outcome Measures

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.
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.
Objective Response Rate (ORR)
Objective Response Rate (ORR), evaluated by investigators on radiological images according to RECIST 1.1.
Progression free survival (PFS)
Progression free survival (PFS), the event is the time that diseased progressed evaluated by investigators or death occurs.
Overall survival (OS),
Overall survival (OS), the event is the time that all cause death occurs.

Full Information

First Posted
May 3, 2023
Last Updated
September 1, 2023
Sponsor
OncoC4, Inc.
Collaborators
OncoC4 AU Pty Ltd, Avance Clinical Pty Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05858736
Brief Title
Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
Acronym
PRESERVE-009
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OncoC4, Inc.
Collaborators
OncoC4 AU Pty Ltd, Avance Clinical Pty Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Three dose levels will be tested sequentially.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Level 1
Arm Type
Experimental
Arm Description
AI-061, 200 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year.
Arm Title
Level 2
Arm Type
Experimental
Arm Description
AI-061, 400 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year.
Arm Title
Level 3
Arm Type
Experimental
Arm Description
AI-061, 600 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year.
Intervention Type
Drug
Intervention Name(s)
AI-061
Other Intervention Name(s)
Anti-PD-1 and anti-CTLA-4 in 1:1 co-formulation
Intervention Description
A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC- 392 (Anti-CTLA-4) Antibodies.
Primary Outcome Measure Information:
Title
Dose Limiting Toxicity (DLT)
Description
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.
Time Frame
21 days after first treatment
Title
Maximum Toxicity Dose (MTD)
Description
Maximal tolerable dose (MTD), the study drug, AI-061, dose level that has two out of six subjects who have DLT.
Time Frame
21 day after first treatment
Title
Recommended Phase II Dose (RP2D)
Description
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.
Time Frame
21 days after first treatment
Title
Incidence of treatment emergent adverse events (TEAE)
Description
Incidence of treatment emergent adverse events (TEAE) according to CTCAE v5.0.
Time Frame
From the day with first treatment to 90 days after the last treatment.
Secondary Outcome Measure Information:
Title
Cmax of AI-061
Description
The highest Serum concentration of AI-061 after IV infusion at cycle 1 and cycle 3 dosings from different timepoints after drug administration.
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.
Title
The serum half-life of AI-061
Description
To determine the drug concentration in serum samples that are taken in various timepoints during the treatment in order to calculate drug half life.
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.
Title
Objective Response Rate (ORR)
Description
Objective Response Rate (ORR), evaluated by investigators on radiological images according to RECIST 1.1.
Time Frame
Up to 1 year.
Title
Progression free survival (PFS)
Description
Progression free survival (PFS), the event is the time that diseased progressed evaluated by investigators or death occurs.
Time Frame
Up to 1 year.
Title
Overall survival (OS),
Description
Overall survival (OS), the event is the time that all cause death occurs.
Time Frame
Up to 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pan Zheng, MD, PhD
Phone
2027516823
Email
pzheng@oncoc4.com
First Name & Middle Initial & Last Name or Official Title & Degree
Faye Liu, PhD
Email
fliu@oncoc4.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rohit Joshi, MD
Organizational Affiliation
Cancer Research South Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Private Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Mater Misericordiae Ltd.
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikram Jain, MD
Facility Name
Tasman Oncology Research
City
Southport
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Hill, MD
Facility Name
Cancer Research SA
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohit Joshi, MD
Facility Name
Southern Oncology Clinical Research Unit
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ganessan Kitchenadasse, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors

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