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Trial record 5 of 6 for:    ONC-392
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Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors (PRESERVE-009)

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ClinicalTrials.gov Identifier: NCT05858736
Recruitment Status : Recruiting
First Posted : May 15, 2023
Last Update Posted : September 6, 2023
Sponsor:
Collaborators:
OncoC4 AU Pty Ltd
Avance Clinical Pty Ltd.
Information provided by (Responsible Party):
OncoC4, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
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 Drug: AI-061 Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Three dose levels will be tested sequentially.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 11, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : June 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Level 1
AI-061, 200 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year.
 Drug: AI-061
A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC- 392 (Anti-CTLA-4) Antibodies.
Other Name: Anti-PD-1 and anti-CTLA-4 in 1:1 co-formulation
Experimental: Level 2
AI-061, 400 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year.
 Drug: AI-061
A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC- 392 (Anti-CTLA-4) Antibodies.
Other Name: Anti-PD-1 and anti-CTLA-4 in 1:1 co-formulation
Experimental: Level 3
AI-061, 600 mg, intravenous infusion, Q3W, up to 17 cycles or approximately 1 year.
 Drug: AI-061
A 1:1 Co-formulation of AI-025 (Anti-PD-1) and ONC- 392 (Anti-CTLA-4) Antibodies.
Other Name: Anti-PD-1 and anti-CTLA-4 in 1:1 co-formulation


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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 highest Serum concentration of AI-061 after IV infusion at cycle 1 and cycle 3 dosings from different timepoints after drug administration.

  2. 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. ]
    To determine the drug concentration in serum samples that are taken in various timepoints during the treatment in order to calculate drug half life.

  3. Objective Response Rate (ORR) [ Time Frame: Up to 1 year. ]
    Objective Response Rate (ORR), evaluated by investigators on radiological images according to RECIST 1.1.

  4. Progression free survival (PFS) [ Time Frame: Up to 1 year. ]
    Progression free survival (PFS), the event is the time that diseased progressed evaluated by investigators or death occurs.

  5. Overall survival (OS), [ Time Frame: Up to 1 year. ]
    Overall survival (OS), the event is the time that all cause death occurs.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05858736


Contacts
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Contact: Pan Zheng, MD, PhD 2027516823 pzheng@oncoc4.com
Contact: Faye Liu, PhD fliu@oncoc4.com

Locations
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Australia, New South Wales
St. Vincent's Private Hospital Not yet recruiting
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
Mater Misericordiae Ltd. Recruiting
Brisbane, Queensland, Australia, 4006
Principal Investigator: Vikram Jain, MD         
Tasman Oncology Research Recruiting
Southport, Queensland, Australia, 4120
Principal Investigator: Andrew Hill, MD         
Australia, South Australia
Cancer Research SA Recruiting
Adelaide, South Australia, Australia, 5000
Principal Investigator: Rohit Joshi, MD         
Southern Oncology Clinical Research Unit Not yet recruiting
Bedford Park, South Australia, Australia, 5042
Principal Investigator: Ganessan Kitchenadasse, MD         
Sponsors and Collaborators
OncoC4, Inc.
OncoC4 AU Pty Ltd
Avance Clinical Pty Ltd.
Investigators
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Principal Investigator: Rohit Joshi, MD Cancer Research South Australia
More Information
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Responsible Party: OncoC4, Inc.
ClinicalTrials.gov Identifier: NCT05858736    
Other Study ID Numbers: AI-061-AU-01
First Posted: May 15, 2023    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carcinoma
Endometrial Neoplasms
Fallopian Tube Neoplasms
Squamous Cell Carcinoma of Head and Neck
Anus Neoplasms
Bile Duct Neoplasms
Cystadenocarcinoma, Serous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma, Squamous Cell
Adenocarcinoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases