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Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer Subjects

An Open-Label Study to Assess the Safety, Tolerability, and Efficacy of Active Immunotherapy With Dose Escalation and Cohort Expansion of OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal, or Breast Cancer Subjects

NCT02310464•OBI Pharma, Inc

View on ClinicalTrials.gov

Summary

The purpose of this clinical study is to assess the safety and tolerability and efficacy of active immunotherapy with dose escalation and cohort expansion of OBI-833 in advanced/metastatic gastric, lung, colorectal, or breast cancer subjects.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects ≥21 years of age
•2. Dose escalation phase: Histologically or cytologically confirmed diagnosis of gastric, lung, colorectal or breast cancer on file Cohort expansion phase: Histologically or cytologically confirmed diagnosis of Globo H-positive NSCLC
•3. Dose escalation: Subjects with recurrent or metastatic incurable disease that failed to respond to at least one line of anticancer standard therapy and for which standard treatment is no longer effective or tolerable.
•Cohort expansion phase: Subjects with recurrent or metastatic NSCLC who have achieved stable disease (SD), or partial response (PR) status after at least 1 regimen of anticancer therapy (i.e., chemotherapy, or targeted therapy, or PD-1/PD-L1 antagonists either alone or in combination) , and there are no standard treatments available except permitted Target or PD-1/PD-L1 therapies
•4. Measurable disease (i.e., present with at least one measurable lesion per RECIST, version 1.1.
•5. Dose Escalation Phase: No known central nervous system (CNS) metastases or neurological symptoms possibly related to active CNS metastasis in Dose Escalation Phase.
•Cohort Expansion Phase: Subjects with asymptomatic CNS metastases for at least four weeks before study drug treatment
•6. Performance status: ECOG ≤ 1
•7. Organ Function Requirements - Subjects must have adequate organ functions as defined below:
•AST/ALT ≤ 3X ULN (upper limit of normal) AST/ALT ≤ 5X ULN \[with underlying liver metastasis\] Total bilirubin ≤ 2.0 X ULN Serum creatinine ≤ 1.5X ULN ANC ≥ 1500 /µL Platelets \> 100,000/µL
+2 more criteria

Exclusion Criteria

•1. Patients who have not received standard chemotherapy, hormonal or targeted therapy for their underlying advanced/metastatic cancer.
•2. Subjects who are pregnant or breast-feeding at entry.
•3. Subjects with splenectomy.
•4. Subjects with known or clinically manifest, symptomatic CNS metastases in Dose Escalation Phase.
•5. Subjects with HIV infection, active hepatitis B infection or active hepatitis C infection.
•6. Subjects with any autoimmune disorders requiring iv/oral steroids or immunosuppressive or immunomodulatory therapies.
•\- e.g., Type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Grave's disease, Hashimoto's thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, etc.
•7. Subjects with any known uncontrolled inter-current illness including ongoing or active infections, symptomatic congestive heart failure (NYHA\>2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•8. Dose escalation phase: Subjects with any of the following MEDICATIONS within 4 weeks prior to IP treatment, except permitted therapies as listed in section 7.1:
•* Chemotherapeutic Agent
+12 more criteria

Locations (4)

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Key Dates

Start Date

December 22, 2015

Primary Completion Date

December 22, 2020

Completion Date

February 2, 2021

Last Updated

October 3, 2022

Enrollment

ACTUAL participants

Conditions

Metastatic Gastric CancerMetastatic Breast CancerMetastatic Colorectal CancerMetastatic Lung Cancer

Interventions

OBI-833/OBI-821

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE1/PHASE2

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of Active Immunotherapy With OBI-833 (Globo H-CRM197) in Advanced/Metastatic Gastric, Lung, Colorectal or Breast Cancer Subjects

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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