Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Vaccines

Capecitabine

Participants will be administered adagloxad simolenin combined with OBI-821 for up to a total of 21 subcutaneous injections over a period of 100 weeks.

Patient will also receive standard of care (SOC) treatment.

Study visit intervals will be identical to those in Arm 1.

Patient will receive standard of care (SOC) treatment.

In the neoadjuvant and adjuvant phases of the study for a total of 100 weeks; subcutaneously injections.

adagloxad simolenin combined with OBI-821

The Globo H IHC assay will be used to identify eligible patients who may clinically benefit from the OBI-822 treatment, defined by Globo H expression.

Globo H IHC Assay

Standard of care treatment consisting of observation alone, adjuvant capecitabine or platinum monotherapy over a 100 week period.

Standard of care treatment

OBI Pharma CT.gov Assistant

OBI Investigator Site

Hope Rugo, MD

The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC.

Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC

The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With High Risk, Early Stage Globo H-Positive Triple Negative Breast Cancer

The outcome measure of the study is IDFS, defined by the STEEP system as the first occurrence of the time from the date of randomization to the date of first invasive disease recurrence (local, regional or distant), the date of secondary primary invasive cancer (breast or not), or the date of death from any cause.

OS is defined as the time from randomization to date of death from any cause

QoL defined as time to definitive deterioration in Health-related Quality of Life (HRQOL) using the global health status/QoL scale from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and the European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L). QoL baseline established at randomization.

Definitive deterioration defined as a 5% worsening relative to baseline in the HRQOL scale score from EORTC QLQ-C30 questionnaires with no subsequent improvement above threshold, scored with the EORTC QLQ-C30 v3.0 Scoring Manual. The EQ-5D-5L questionnaire assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, rated by the patient. It is a standardized measure of health status to provide a simple, generic measure of health for clinical and economic appraisal. 28 questions have a 4 point scale: not at all(1) to very much(4). 2 questions have a 7-point scale: very poor (1) to excellent(7).

BCFI is defined by the STEEP system as the first occurrence of the time from the date of randomization to the date of the first invasive disease recurrence (local, regional or distant), the date of ductal carcinoma in situ (ipsilateral or contralateral), or the date of death from breast cancer

DDFS is defined by the STEEP system as the first occurrence of the time from the date of randomization to the date of the first distant disease recurrence, the date of the second primary invasive cancer (non-breast), or the date of death from any cause

Adverse Events will be graded and recorded by investigators per National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).

OBI Pharma, Inc

Antibodies

Antibodies, Monoclonal

Immunoglobulins

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).

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

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.

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

Apostolia Tsimberidou, MD, PHD

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.

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

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.

Assessment of OBI-888 clinical benefit rate for dose escalation and cohort expansion phases of the OBI-888-001 study.

Treatment-emergent adverse events (TEAEs) in Parts A or B experienced by ≥5% of total subjects in Part A and Part B. TEAEs are presented by decreasing incidence for the total of subjects in Part A and Part B

OBI-888 5 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles

Part A, Dose Escalation - OBI-888 5 mg/kg

OBI-888 10 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles

Part A, Dose Escalation - OBI-888 10 mg/kg

OBI-888 20 mg/kg was administered as an IV infusion for approximately 90 minutes (±10 minutes) on Days 1, 8, 15 and 22 of each 28-day cycle for 2 cycles

Part A, Dose Escalation - OBI-888 20 mg/kg

Part B, Cohort Expansion - Cohort 1, Pancreatic

Part B, Cohort Expansion - Cohort 2, Esophageal

Part B, Cohort Expansion - Cohort 3, Gastric

Part B, Cohort Expansion - Cohort 4, Colorectal

Part B, Cohort Expansion - Cohort 5, Basket

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

The safety population consisted of all enrolled subjects who received at least 1 dose of study drug.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC	NCT03562637	Triple Negative...	adagloxad simol... Globo H IHC Ass... Standard of car...	18 Years -	OBI Pharma, Inc
This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.	NCT03573544	Metastatic Soli... Locally Advance...	OBI-888 OBI-888 Globo H IHC Ass...	18 Years -	OBI Pharma, Inc
This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.	NCT03573544	Metastatic Soli... Locally Advance...	OBI-888 OBI-888 Globo H IHC Ass...	18 Years -	OBI Pharma, Inc

Spots Global Cancer Trial Database for globo h ihc assay