Title

A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers
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 Started
Oct 06
2020
Primary Completion
Nov 30
2022
Anticipated
Study Completion
Nov 30
2022
Anticipated
Last Update
Apr 20
2022

Drug OC-001

Monotherapy in Phase 1b

Drug OC-001 in Combination

Anti-PD-1/anti-PD-L1 Ab administered per approved prescribing schedule, in Phase 2a

Drug: Dose Escalation Experimental

Escalating doses of OC-001 administered intravenously (IV)

Drug: Combination: Tumor Type 1 Experimental

Doses of OC-001 administered by IV in combination anti-PD-1 or anti-PD-L1 Antibody (Ab)

Drug: Combination: Tumor Type 2 Experimental

Doses of OC-001 administered by IV in combination anti-PD-1 or anti-PD-L1 Antibody (Ab)

Criteria

Inclusion Criteria:

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

Have the presence of evaluable disease for the Phase 1b part of the study
Have the presence of evaluable and measurable disease for the Phase 2a part of the study
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.

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.
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.
Have adequate organ function
Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued cytotoxic therapy, biologic therapy, immunotherapy, radiotherapy, and cancer-related hormonal therapy at least 21 days prior to study enrollment
Are recovered or recovering from the acute adverse effects of any chemotherapy, biologic, therapy, immunotherapy, cancer-related hormonal therapy, or radiotherapy
Patients who have had major surgery must be fully recovered and greater than (≥)4 weeks post-operative
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)
Women of child-bearing potential must have a negative serum pregnancy test documented
Have an estimated life expectancy of at least 3 months

Exclusion Criteria:

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
Have a history of major organ transplant (e.g., heart, lungs, liver, and kidney) or an autologous or allogeneic hematopoietic stem cell transplant
Females who are pregnant or nursing
Have known, symptomatic acquired immuno deficiency syndrome (AIDS) or active hepatitis A, B or C
Previous treatment-related, severe (≥Grade 3) Adverse Event (AE) or any neurologic or ocular AE while receiving an IO agent
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
Active or prior documented inflammatory bowel disease
History of tuberculosis, interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required corticosteroid therapy
Receipt of live attenuated vaccination within 28 days prior
Current or prior use of immunosuppressive medication within 28 days prior
Are currently enrolled in another clinical study of an investigational medicinal product
Have a second primary malignancy that may affect the interpretation of results
Are unwilling or unable to participate in, or do not have tissue adequate for a tumor biopsy
No Results Posted