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

  • STATUS
    Recruiting
  • days left to enroll
    32
  • participants needed
    80
  • sponsor
    Ocellaris Pharma, Inc.
Updated on 6 May 2022
cancer
tyrosine
lymphoma
cytotoxic drug
systemic therapy
estrogen
serum pregnancy test
measurable disease
carcinoma
breast cancer
growth factor
squamous cell carcinoma
non-melanoma skin cancer
endocrine therapy
lung cancer
treatment regimen
biological factors
progesterone
major surgery
cytotoxic chemotherapy
metastasis
hormone therapy
epidermal growth factor receptor
ROS1
HER2
EGFR
chemotherapy regimen
pd-l1
anaplastic lymphoma
gastric cancer
programmed cell death 1 ligand 1
human epidermal growth factor
cancer treatment
primary cancer
cancer chemotherapy
biological therapy
solid tumor
investigational therapy
triple negative breast cancer
ovarian cancer
progesterone receptor
erbb2
epidermal growth factor
estrogen receptor
squamous cell carcinoma of head and neck
bladder cancer
sarcoma
investigational treatment
immune checkpoint inhibitor
metastatic cancer
growth factors
bladder tumor
head and neck carcinoma
cancer of the ovary
lung carcinoma
proto-oncogene tyrosine-protein kinase ros

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

Details
Condition 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
Treatment OC-001, OC-001 in Combination
Clinical Study IdentifierNCT04260802
SponsorOcellaris Pharma, Inc.
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

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
Have adequate organ function
is locally advanced or metastatic. At least one cancer type will be selected
Have a performance status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
amongst the ones evaluated in the Phase 1b part of the study
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
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)
Patients who have had major surgery must be fully recovered and greater than (≥)4 weeks post-operative
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
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
Previous treatment-related, severe (≥Grade 3) Adverse Event (AE) or any neurologic or ocular AE while receiving an IO agent
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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