Clinical Trials /

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

NCT04260802

Description:

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

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: OCEL-01
  • NCT ID: NCT04260802

Conditions

  • 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

Interventions

DrugSynonymsArms
OC-001Drug: Dose Escalation
OC-001Drug: Combination: Tumor Type 1

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Drug: Dose EscalationExperimentalEscalating doses of OC-001 administered intravenously (IV)
  • OC-001
Drug: Combination: Tumor Type 1ExperimentalDoses of OC-001 administered by IV in combination with anti-PD-1 or anti-PD-L1 Antibody (Ab)
  • OC-001
Drug: Combination: Tumor Type 2ExperimentalDoses of OC-001 administered by IV in combination with anti-PD-1 or anti-PD-L1 Antibody (Ab)
  • OC-001

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with a Dose Limiting Toxicity (DLT) in Phase 1b
Time Frame:Baseline through Cycle 1 (Day 28)
Safety Issue:
Description: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)

Secondary Outcome Measures

Measure:Area Under the OC-001 Plasma Concentration Time Curve (AUC) in Phase 1b
Time Frame:Baseline through 12 weeks
Safety Issue:
Description:After single and multiple dose administration
Measure:Maximum Observed OC-001 Concentration (Cmax) in Phase 1b
Time Frame:Baseline through 12 weeks
Safety Issue:
Description:After single and multiple dose administration
Measure:Time to reach OC-001 Cmax (Tmax) in Phase 1b
Time Frame:Baseline through 12 weeks
Safety Issue:
Description:Time of maximum concentration observed
Measure:Minimum Observed OC-001 Concentration (Cmin) in Phase 1b
Time Frame:Baseline through 12 weeks
Safety Issue:
Description:After single and multiple dose administration
Measure:Overall Response Rate (ORR) in Phase 2a
Time Frame:Baseline up to two years
Safety Issue:
Description:In combination with an anti-PD-1 or anti-PD-L1 antibody
Measure:Progression Free Survival (PFS) in Phase 2a
Time Frame:Baseline up to two years
Safety Issue:
Description:In combination with an anti-PD-1 or anti-PD-L1 antibody
Measure:Duration of Response (DOR) in Phase 2a
Time Frame:Baseline up to two years
Safety Issue:
Description:In combination with an anti-PD-1 or anti-PD-L1 antibody
Measure:Time to Response (TTR) in Phase 2a
Time Frame:Baseline up to two years
Safety Issue:
Description:In combination with an anti-PD-1 or anti-PD-L1 antibody
Measure:Disease Control Rate (DCR) in Phase 2a
Time Frame:Baseline up to two years
Safety Issue:
Description:In combination with an anti-PD-1 or anti-PD-L1 antibody
Measure:Overall Survival (OS) in Phase 2a
Time Frame:Baseline up to two years
Safety Issue:
Description:In combination with an anti-PD-1 or anti-PD-L1 antibody
Measure:One-Year Survival Rate in Phase 2a
Time Frame:Baseline up to two years
Safety Issue:
Description:In combination with an anti-PD-1 or anti-PD-L1 antibody
Measure:Maximum Observed OC-001 Concentration (Cmax) in Phase 2a
Time Frame:Baseline through 12 weeks
Safety Issue:
Description:In combination with an anti-PD-1 or anti-PD-L1 antibody
Measure:Minimum Observed OC-001 Concentration (Cmin) in Phase 2a
Time Frame:Baseline through 12 weeks
Safety Issue:
Description:In combination with an anti-PD-1 or anti-PD-L1 antibody

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Ocellaris Pharma, Inc.

Last Updated

February 5, 2020