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
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
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of participants with a Dose Limiting Toxicity (DLT) in Phase 1b
Secondary Outcome
Area Under the OC-001 Plasma Concentration Time Curve (AUC) in Phase 1b
Condition
Cancer
Intervention
OC-001
Study Arms / Comparison Groups
Drug: Dose Escalation
Description: Escalating doses of OC-001 administered intravenously (IV)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
80
Start Date
October 6, 2020
Completion Date
November 2022
Primary Completion Date
November 2022
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ocellaris Pharma, Inc, 3176517036, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT04260802
Organization ID
OCEL-01
Responsible Party
Sponsor
Study Sponsor
Ocellaris Pharma, Inc.
Study Sponsor
Ocellaris Pharma, Inc, Study Director, Ocellaris Pharma, Inc.
Verification Date
January 2021