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