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

NCT04260802 | Terminated Phase 1

• 1 other identifier: OCEL-01
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 5

Brief Summary

This study will investigate OC-001 as monotherapy, and in combination with, Avelumab, in various cancer types

Conditions

Cancer; Neoplasms; 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; Squamous Cell Carcinoma; Sarcoma; Merkel Cell Carcinoma; Bladder Cancer; Metastatic Cancer; Locally Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• Number of participants with a Dose Limiting Toxicity (DLT) in Phase 1b

  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)

  Baseline through Cycle 1 (Day 28)

• Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a

  Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a

  Baseline up to two years

Secondary Outcomes (14)

• Area Under the OC-001 Plasma Concentration Time Curve (AUC) in Phase 1b

  Baseline through 12 weeks

• Maximum Observed OC-001 Concentration (Cmax) in Phase 1b

  Baseline through 12 weeks

• Time to reach OC-001 Cmax (Tmax) in Phase 1b

  Baseline through 12 weeks

• Minimum Observed OC-001 Concentration (Cmin) in Phase 1b

  Baseline through 12 weeks

• Overall Response Rate (ORR) in Phase 2a

  Baseline up to two years

Study Arms (3)

Drug: Phase 1b: Dose Escalation (monotherapy)

EXPERIMENTAL

Escalating doses of OC-001 administered intravenously (IV)

Drug: Phase 1b Dose: Escalation (Combination therapy)

EXPERIMENTAL

Escalating doses of OC-001 administered by IV in combination Avelumab.

Drug: Drug: OC-001 in Combination with Avelumab

Drug: Phase 2a

EXPERIMENTAL

Doses of OC-001 administered by IV in combination with Avelumab b)

Drug: Drug: OC-001 in Combination with Avelumab

Interventions

OC-001 DRUG

Administered IV.

Drug: OC-001 in Combination with Avelumab DRUG

Administered IV.

Drug: Phase 1b Dose: Escalation (Combination therapy); Drug: Phase 2a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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 Monotherapy
• Have the presence of evaluable and measurable disease for the Phase 1b combination part and 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ocellaris Pharma, Inc.: lead

Study Sites (5)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Ottawa Hospital Cancer Centre (OHRI)

Ottawa, Ontario, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2C1, Canada

Location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0A9, Canada

Location

Jewish General Hospital - Clinical Research Unit

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Triple Negative Breast Neoplasms; Stomach Neoplasms; Uterine Cervical Neoplasms; Ovarian Neoplasms; Carcinoma, Hepatocellular; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Carcinoma, Squamous Cell; Sarcoma; Carcinoma, Merkel Cell; Urinary Bladder Neoplasms

Interventions

avelumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Head and Neck Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasms, Squamous Cell; Neoplasms, Connective and Soft Tissue; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Urinary Bladder Diseases

Study Officials

• Ocellaris Pharma, Inc

  Ocellaris Pharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: September 24, 2020
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

CA (5)