This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
Status: | Recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/1/2018 |
Start Date: | May 7, 2018 |
End Date: | June 10, 2021 |
Contact: | Thomas Wilson |
Email: | twilson@obipharmausa.com |
Phone: | 302-359-0565 |
A Phase I, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
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.
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.
Inclusion Criteria:
Patients must meet all of the following criteria in order to be included in the study:
1. Male or female patients, 18 years of age or older at the time of consent.
2. Provide written informed consent prior to performing any study-related procedure.
3. Histologically or cytologically confirmed patients with advanced or metastatic solid
tumors for both Dose Escalation and Expansion cohort.
4. Patients for whom no available treatment options are known to confer clinical benefit.
5. Measurable disease (i.e., at least one measurable lesion per Response Evaluation
Criteria in Solid Tumors (RECIST), version 1.1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. At least 21 days since the last chemotherapy, immunotherapy, biological or radiation,
or approved tyrosine kinase inhibitor (TKI) therapy.
8. 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 >60 mL/minute using Cockcroft Gault equation
- Hematologic:
- White Blood Count (WBC) ≥3,500/µL
- Absolute neutrophil count ≥1000/µL
- Absolute lymphocytes ≥ 0.5 ×10 9/l
- Platelets ≥75,000/µL
- Hemoglobin ≥9 g/dL
9. Normal coagulation profile except:
- International Normalized Ratio (INR) within 1.5 × ULN
- Activated partial thromboplastin time (aPTT) within 1.5 × ULN
10. 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.
11. Females of childbearing potential must have negative 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.
12. Cannot be breast feeding.
Exclusion Criteria:
Patients meeting any of the following criteria are ineligible to participate in this study:
1. Patients currently participating in or has participated in a study of an
investigational anticancer therapy received within 28 days prior to the first dose of
OBI-888.
2. 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.
3. 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.
4. Presence of primary immunodeficiency or receiving systemic steroids of >10 mg/day of
prednisone or equivalent or other immunosuppressive agents within 7 days prior to the
first dose of OBI 888.
5. 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.
6. Patients with a history of solid organ transplant.
7. 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.
8. Receipt of any prior therapy targeting Globo H.
9. Prior anti cancer mAb within 3 weeks or 5 half lives prior to the first dose of OBI
888.
10. Known hypersensitivity to OBI 888 or its excipients.
11. Has known central nervous system metastases and/or leptomeningeal metastases.
12. 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.
13. Unable or unwilling to complete any study procedures or discontinue any prohibited or
restricted medications for the duration of the study.
14. Positive serum pregnancy test.
15. Is receiving any concurrent prohibited medication
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