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

November 27, 2023 updated by: Ocellaris Pharma, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute
        • Contact:
          • Quincy Chu
          • Phone Number: 780-432-8248
        • Principal Investigator:
          • Quincy Chu
    • Ontario
      • Ottawa, Ontario, Canada
        • Recruiting
        • Ottawa Hospital Cancer Centre (OHRI)
        • Contact:
        • Principal Investigator:
          • Derek Jonker
      • Toronto, Ontario, Canada, M5G 2C1
        • Recruiting
        • Princess Margaret Hospital
        • Contact:
          • Amit Oza
          • Phone Number: 416-946-2818
        • Principal Investigator:
          • Amit Oza
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital - Clinical Research Unit
        • Principal Investigator:
          • Wilson Miller
        • Contact:
      • Montréal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre hospitalier de l'Université de Montréal (CHUM)
        • Contact:
        • Principal Investigator:
          • Diane Provencher

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline through Cycle 1 (Day 28)
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
Baseline up to two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline through 12 weeks
Maximum Observed OC-001 Concentration (Cmax) in Phase 1b
Time Frame: Baseline through 12 weeks
After single and multiple dose administration
Baseline through 12 weeks
Time to reach OC-001 Cmax (Tmax) in Phase 1b
Time Frame: Baseline through 12 weeks
Time of maximum concentration observed
Baseline through 12 weeks
Minimum Observed OC-001 Concentration (Cmin) in Phase 1b
Time Frame: Baseline through 12 weeks
After single and multiple dose administration
Baseline through 12 weeks
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
Baseline up to two years
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
Baseline up to two years
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
Baseline up to two years
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
Baseline up to two years
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
Baseline up to two years
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
Baseline up to two years
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
Baseline up to two years
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
Baseline through 12 weeks
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
Baseline through 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocellaris Pharma, Inc.

Investigators

  • Study Director: Ocellaris Pharma, Inc, Ocellaris Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2020

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCEL-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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