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A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04260802
Recruitment Status : Not yet recruiting
First Posted : February 7, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Ocellaris Pharma, Inc.

Brief Summary:
This study will investigate OC-001 as monotherapy, and in combination with an anti-Programmed Cell Death Protein-1 (PD-1) or anti-Programmed Cell Death Ligand-1 (PD-L1) Antibody inhibitor, in various cancer types

Condition or disease Intervention/treatment Phase
Cancer Neoplasms Metastatic Cancer Triple Negative Breast Cancer Gastric Cancer Cervical Cancer Ovarian Cancer Hepatocellular Carcinoma Squamous Cell Carcinoma of Head and Neck Urothelial Carcinoma Urothelial Neoplasm Non Small Cell Lung Cancer Renal Cell Carcinoma Locally Advanced Solid Tumor Locally Advanced Malignant Neoplasm Squamous Cell Carcinoma Sarcoma Merkel Cell Carcinoma Bladder Cancer Drug: OC-001 Drug: OC-001 in Combination Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2a Two-Part, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of OC-001 as Monotherapy and in Combination With an Anti-PD-1/Anti-PD-L1 Antibody in Patients With Selected Locally Advanced or Metastatic Cancers
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022


Arm Intervention/treatment
Experimental: Drug: Dose Escalation
Escalating doses of OC-001 administered intravenously (IV)
Drug: OC-001
Monotherapy in Phase 1b

Experimental: Drug: Combination: Tumor Type 1
Doses of OC-001 administered by IV in combination anti-PD-1 or anti-PD-L1 Antibody (Ab)
Drug: OC-001 in Combination
Anti-PD-1/anti-PD-L1 Ab administered per approved prescribing schedule, in Phase 2a

Experimental: Drug: Combination: Tumor Type 2
Doses of OC-001 administered by IV in combination anti-PD-1 or anti-PD-L1 Antibody (Ab)
Drug: OC-001 in Combination
Anti-PD-1/anti-PD-L1 Ab administered per approved prescribing schedule, in Phase 2a




Primary Outcome Measures :
  1. Number of participants with a Dose Limiting Toxicity (DLT) in Phase 1b [ Time Frame: Baseline through Cycle 1 (Day 28) ]
    A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the criteria identified in the Common Terminology Criteria for Adverse Events (CTCAE, Version 5)

  2. Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a [ Time Frame: Baseline up to two years ]
    Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a


Secondary Outcome Measures :
  1. Area Under the OC-001 Plasma Concentration Time Curve (AUC) in Phase 1b [ Time Frame: Baseline through 12 weeks ]
    After single and multiple dose administration

  2. Maximum Observed OC-001 Concentration (Cmax) in Phase 1b [ Time Frame: Baseline through 12 weeks ]
    After single and multiple dose administration

  3. Time to reach OC-001 Cmax (Tmax) in Phase 1b [ Time Frame: Baseline through 12 weeks ]
    Time of maximum concentration observed

  4. Minimum Observed OC-001 Concentration (Cmin) in Phase 1b [ Time Frame: Baseline through 12 weeks ]
    After single and multiple dose administration

  5. Overall Response Rate (ORR) in Phase 2a [ Time Frame: Baseline up to two years ]
    In combination with an anti-PD-1 or anti-PD-L1 antibody

  6. Progression Free Survival (PFS) in Phase 2a [ Time Frame: Baseline up to two years ]
    In combination with an anti-PD-1 or anti-PD-L1 antibody

  7. Duration of Response (DOR) in Phase 2a [ Time Frame: Baseline up to two years ]
    In combination with an anti-PD-1 or anti-PD-L1 antibody

  8. Time to Response (TTR) in Phase 2a [ Time Frame: Baseline up to two years ]
    In combination with an anti-PD-1 or anti-PD-L1 antibody

  9. Disease Control Rate (DCR) in Phase 2a [ Time Frame: Baseline up to two years ]
    In combination with an anti-PD-1 or anti-PD-L1 antibody

  10. Overall Survival (OS) in Phase 2a [ Time Frame: Baseline up to two years ]
    In combination with an anti-PD-1 or anti-PD-L1 antibody

  11. One-Year Survival Rate in Phase 2a [ Time Frame: Baseline up to two years ]
    In combination with an anti-PD-1 or anti-PD-L1 antibody

  12. Maximum Observed OC-001 Concentration (Cmax) in Phase 2a [ Time Frame: Baseline through 12 weeks ]
    In combination with an anti-PD-1 or anti-PD-L1 antibody

  13. Minimum Observed OC-001 Concentration (Cmin) in Phase 2a [ Time Frame: Baseline through 12 weeks ]
    In combination with an anti-PD-1 or anti-PD-L1 antibody



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Have histological or cytological evidence of a diagnosis of selected cancer types that is locally advanced and/or metastatic

    1. Have the presence of evaluable disease for the Phase 1b part of the study
    2. Have the presence of evaluable and measurable disease for the Phase 2a part of the study
    3. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their disease or patients who have refused standard treatments.
  2. Cancer treatment and type criteria:

    • Have received at least 1 but no more than 4 prior systemic therapies for locally advanced or metastatic disease (e.g., hormonal, cytotoxic, etc.) for the following cancer types, for Phase 1b:
    • Triple Negative Breast Cancer (TNBC): Must have recurrent/refractory TNBC, defined as any breast cancer that expresses less than (˂)1% estrogen receptor (ER), ˂ 1% progesterone receptor (PR), and is Human Epidermal Growth Factor Receptor 2 (Her2) negative. Must have failed at least one chemotherapy regimen.
    • Gastric Cancer: Must have failed a platinum-containing chemotherapy regime.
    • Cervical Cancer: Must have failed at least one chemotherapy regimen.
    • Ovarian Cancer: Must have failed a platinum-containing chemotherapy regimen but not be platinum refractory.
    • Hepatocellular Cell Carcinoma (HCC): May have failed unlimited liver local therapies.
    • Sarcoma: Must have failed at least one prior chemotherapy regimen.
    • Squamous Cell Carcinoma of Head and Neck (SCCHN): Must have failed a platinum-containing chemotherapy regiment. Must have failed a previous immune checkpoint inhibitor.
    • Bladder Cancer: Must have failed a platinum-containing chemotherapy regiment. Must have failed a previous immune checkpoint inhibitor.
    • Non Small Cell Lung Cancer (NSCLC): Must have failed a platinum-containing chemotherapy regimen or Immuno Oncology (IO) agent in the first line. Must have failed a previous immune checkpoint inhibitor. Must not have any history of tumors that test positive for epidermal growth factor receptor (EGFR), Receptor Tyrosine Kinase (ROS1) , Anaplastic Lymphoma Kinase (ALK) mutations or ALK fusions or any other mutations for which tyrosine kinase inhibitors are available.
    • Renal Cell Carcinoma (RCC): Must have failed at least one prior systemic therapy. Must have failed a previous IO agent.
    • Urothelial Cancer: Must have failed at least one prior systemic therapy. Must have failed a previous IO agent.
    • Merkel Cell: Must have failed at least 1 prior systemic therapy for advanced disease and may have failed a previous IO agent.
    • Squamous Cell Carcinoma of the Skin: Must have failed at least 1 prior systemic therapy for advanced disease and may have failed a previous IO agent.
  3. For Phase 2a: Must have histological or cytological confirmation of a solid tumor that is locally advanced or metastatic. At least one cancer type will be selected amongst the ones evaluated in the Phase 1b part of the study.
  4. Have adequate organ function
  5. Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  6. Have discontinued cytotoxic therapy, biologic therapy, immunotherapy, radiotherapy, and cancer-related hormonal therapy at least 21 days prior to study enrollment
  7. Are recovered or recovering from the acute adverse effects of any chemotherapy, biologic, therapy, immunotherapy, cancer-related hormonal therapy, or radiotherapy
  8. Patients who have had major surgery must be fully recovered and greater than (≥)4 weeks post-operative
  9. Men with partners of child-bearing potential or women with child-bearing potential must agree to use a medically approved contraceptive method during and for at least 12 weeks following the last dose of study drug (e.g., intrauterine device (IUD), birth control pills, or barrier method)
  10. Women of child-bearing potential must have a negative serum pregnancy test documented
  11. Have an estimated life expectancy of at least 3 months

Exclusion Criteria:

  1. Have symptomatic central nervous system (CNS) metastasis. Patients with treated CNS metastases are eligible for this study if they are asymptomatic and off of corticosteroids for a minimum of 7 days. Patients with primary brain tumors are not eligible
  2. Have a history of major organ transplant (e.g., heart, lungs, liver, and kidney) or an autologous or allogeneic hematopoietic stem cell transplant
  3. Females who are pregnant or nursing
  4. Have known, symptomatic acquired immuno deficiency syndrome (AIDS) or active hepatitis A, B or C
  5. Previous treatment-related, severe (≥Grade 3) Adverse Event (AE) or any neurologic or ocular AE while receiving an IO agent
  6. Active or prior documented autoimmune disease within the past 2 years Patients with vitiligo, Grave's disease or psoriasis not requiring systemic treatment within the past 2 years are eligible
  7. Active or prior documented inflammatory bowel disease
  8. History of tuberculosis, interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required corticosteroid therapy
  9. Receipt of live attenuated vaccination within 28 days prior
  10. Current or prior use of immunosuppressive medication within 28 days prior
  11. Are currently enrolled in another clinical study of an investigational medicinal product
  12. Have a second primary malignancy that may affect the interpretation of results
  13. Are unwilling or unable to participate in, or do not have tissue adequate for a tumor biopsy

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): NCT04260802


Contacts
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Contact: Study Director: Ocellaris Pharma, Inc 3176517036 choruspharma@lists.lilly.com

Locations
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Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Quincy Chu    780-432-8248      
Principal Investigator: Quincy Chu         
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2C1
Contact: Amit Oza    416-946-2818      
Principal Investigator: Amit Oza         
Canada, Quebec
Jewish General Hospital - Clinical Research Unit
Montreal, Quebec, Canada, H3T 1E2
Contact: Wilson Miller    514-340-8222      
Principal Investigator: Wilson Miller         
Centre hospitalier de l'Université de Montréal (CHUM)
Montréal, Quebec, Canada, H2X 0A9
Contact: Marie-Eve Rego    514-890-8000 ext 30758    marie-eve.rego.chum@ssss.gouv.qc.ca   
Principal Investigator: Diane Provencher         
Sponsors and Collaborators
Ocellaris Pharma, Inc.
Investigators
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Study Director: Ocellaris Pharma, Inc Ocellaris Pharma, Inc.
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Responsible Party: Ocellaris Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04260802    
Other Study ID Numbers: OCEL-01
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Carcinoma, Merkel Cell
Carcinoma
Carcinoma, Squamous Cell
Triple Negative Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Squamous Cell Carcinoma of Head and Neck
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Squamous Cell
Adenocarcinoma
Breast Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Head and Neck Neoplasms