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

NCT03573544 | Terminated Phase 1 Results FDA Drug FDA Device

• 1 other identifier: OBI-888-001
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 9

Brief 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.

Conditions

Metastatic Solid Tumors; Locally Advanced Solid Tumors

Keywords

mAbs; monoclonal antibodies

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

OBI-888 Escalation Phase

EXPERIMENTAL

Part A: Three cohorts of escalating dose levels of OBI-888 5, 10, and 20 mg/kg liquid form for intravenous infusion to establish maximum tolerated dose (MTD).

Drug: OBI-888; Device: Globo H IHC Assay

OBI-888 Expansion Phase

EXPERIMENTAL

Part B: Five cohorts at dose level 20 mg/kg of liquid form OBI-888 for intravenous infusion.

Drug: OBI-888; Device: Globo H IHC Assay

Interventions

OBI-888 DRUG

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

OBI-888 Escalation Phase

Globo H IHC Assay DEVICE

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

OBI-888 Escalation Phase; OBI-888 Expansion Phase

Eligibility Criteria

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

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:

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.
• 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

Sponsors & Collaborators

• OBI Pharma, Inc: lead

Study Sites (9)

Scripps Clinic Torrey Pines

La Jolla, California, 92037, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

West Cancer Center and Research Institute

Germantown, Tennessee, 38138, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Results Point of Contact

• Title: Dr. Wayne Saville, Chief Medical Officer
• Organization: OBI Pharma, Inc.

waynesaville@obipharmausa.com

619-537-7821

Study Officials

• Apostolia Tsimberidou, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: June 29, 2018
• Study Start: May 7, 2018
• Primary Completion: April 7, 2022
• Study Completion: April 7, 2022
• Last Updated: February 22, 2024
• Results First Posted: February 22, 2024

Record last verified: 2024-02

Locations

US (6); TW (3)