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

Metastatic Solid Tumors Clinical Trial

Official title:

A Phase I/II, 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03573544
• Other study ID #: OBI-888-001
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 7, 2018
• Est. completion date: April 7, 2022

Study information

• Verified date: February 2024
• Source: OBI Pharma, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: April 7, 2022
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

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. 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

8. 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.

9. 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.

10. Cannot be breast feeding.

11. 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

• Cohort 2: Esophageal cancer

• Cohort 3: Gastric cancer

• Cohort 4: Colorectal cancer

• Cohort 5: Basket (any solid tumor type other than those included in Cohorts 1 through 4)

Exclusion Criteria:

Patients meeting any of the following criteria are ineligible to participate in this study:

1. 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.

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 14 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. Known hypersensitivity to OBI 888 or its excipients.

10. Has known, untreated central nervous system metastases and/or leptomeningeal metastases.

11. 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.

12. Is receiving any concurrent prohibited medication

Related Conditions & MeSH terms

• Locally Advanced Solid Tumors
• Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• OBI-888
For the dose-escalation phase, OBI-888 will be given weekly at the dose levels of 5, 10, and 20 mg/kg.
• OBI-888
For the dose-expansion phase, OBI-888 will be given weekly at 20 mg/kg dose level.

Device:
• Globo H IHC Assay
This assay will be used to identify eligible patients who may clinically benefit from the OBI-888 treatment, defined by Globo H expression.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
OBI Pharma, Inc

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Benefit Rate (CR, PR, SD) (%)	Assessment of OBI-888 clinical benefit rate for dose escalation and cohort expansion phases of the OBI-888-001 study.	Every 8 weeks (±1 week) for 6 months, then every 12 weeks (±1 week) until progression or off-study criteria, up to 1 year.