This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.

Stopped early · Phase 1/Phase 2

Conditions studied: Metastatic Solid Tumors, Locally Advanced Solid Tumors

In brief

The purpose of this study is to establish the maximum tolerated dose (MTD) of OBI-888 as monotherapy. And to characterize the safety and preliminary clinical activity profile of the MTD dose of OBI-888 administered as monotherapy in patients with locally advanced or metastatic solid tumors.

Key facts

Study ID

NCT03573544

Run by

OBI Pharma, Inc

People needed

54

Starts

2018-05-07

Expected to finish

2022-04-07

Last updated by the study team

2024-02-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following criteria in order to be included in the study:
• Male or female patients, 18 years of age or older at the time of consent.
• Provide written informed consent prior to performing any study-related procedure.
• Histologically or cytologically confirmed patients with advanced or metastatic solid tumors for both Dose Escalation and Expansion cohort.
• Patients must have been treated with established standard-of-care therapy, or physicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy.
• Measurable disease (i.e., at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function defined as:
• Hepatic:
• Serum alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
• Serum aspartate aminotransferase (AST) ≤3 × ULN, ≤5 × ULN in presence of liver metastases
• Serum bilirubin ≤1.5 × ULN
• Renal:
• Creatinine clearance >30 mL/minute using Cockcroft Gault equation
• Hematologic:
• Absolute neutrophil count ≥1000/µL
• Platelets ≥75,000/µL
• Hemoglobin ≥8 g/dL
• Patient is willing and able to comply with all protocol required assessments, visits, and procedures, including pretreatment tumor biopsy. Archival tumor biopsies are acceptable at baseline.
• Females of childbearing potential must have negative urine or serum pregnancy test prior to starting study therapy, and agree to use a reliable form of contraceptive during the study treatment period and for at least 120 days following the last dose of study drug.
• Subject not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
• Male patients must agree to use an adequate method of contraception during the study treatment period and for at least 120 days following the last dose of study drug.
• Cannot be breast feeding.
• Patients in Part B (Cohort expansion); must have a qualifying, documented Globo H H-score in sponsor-selected tumor types to be enrolled in the respective cohort:
• Cohort 1: Pancreatic cancer

You may not qualify if…

• Patients meeting any of the following criteria are ineligible to participate in this study:
• Less than 3 weeks, from prior cytotoxic chemotherapy or radiation therapy; and less than 5 half-lives or 3 weeks from biological therapies, whichever is shorter, prior to the first dose of OBI-888.
• Has undergone a major surgical procedure (as defined by the investigator) or significant traumatic injury within 28 days prior to the first dose of OBI-888.
• Presence of an active autoimmune or inflammatory disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or other immunosuppressive medications. Local steroid injections, intermittent use of topical, inhaled, ophthalmologic, intra-articular, topical, or intranasal corticosteroids, or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent would not be excluded from the study.
• Presence of primary immunodeficiency or receiving systemic steroids of >10 mg/day of prednisone or equivalent or other immunosuppressive agents within 14 days prior to the first dose of OBI 888.
• Has active bacterial, viral, fungal, or mycobacterial infection requiring systemic therapy, including known infection with human immunodeficiency virus (HIV) or active infection with hepatitis B virus or hepatitis C virus.
• Patients with a history of solid organ transplant.
• Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03), except for alopecia and laboratory values listed in the inclusion criteria.
• Receipt of any prior therapy targeting Globo H.
• Known hypersensitivity to OBI 888 or its excipients.
• Has known, untreated central nervous system metastases and/or leptomeningeal metastases.
• Any medical co morbidity or psychiatric illness that is life threatening or, in the opinion of the Investigator, renders the patient unsuitable for participation in a clinical trial due to possible noncompliance, would place the patient at an unacceptable risk and/or potential to affect interpretation of results of the study.
• Is receiving any concurrent prohibited medication

Where it is running

• Scripps Clinic Torrey Pines — La Jolla, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• West Cancer Center and Research Institute — Germantown, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• China Medical University Hospital — Taichung, Taiwan
• National Cheng Kung University Hospital — Tainan, Taiwan
• Taipei Veterans General Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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