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

NCT02310464 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: OBI-833-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Metastatic Gastric Cancer; Metastatic Breast Cancer; Metastatic Colorectal Cancer; Metastatic Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events

  Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort

Secondary Outcomes (1)

• Maximal Post-baseline Anti-Globo H Antibody Responses

  Approximately 13 weeks for dose escalation cohorts and 44 weeks for expansion cohort

Study Arms (2)

Dose escalation

EXPERIMENTAL

Each subject will be given a total of 10 doses of OBI-833/OBI-821 subcutaneously at weeks 1,2,3,4,6,8,12,16,20,and 24 (Visits 1,2,3,4,5,6,7,8,9 and 10, respectively). Post treatment, subjects will be continually evaluated for safety and immune response every 4 weeks until the end of study, which is 12 weeks after the last dose, i.e., week 36. Subsequently, subjects will be followed for survival every 8 weeks up to 12 months after the end of study.

Drug: OBI-833/OBI-821

Cohort expansion phase

EXPERIMENTAL

Each subject will be given OBI-833/OBI-821 at Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, and every 8 weeks thereafter (Visits 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and every 8 weeks thereafter) until disease progression. For the subjects discontinued treatment because of disease progression, subjects will be continually evaluated for safety and immune response every 8 weeks until the end of the study, which is 24 weeks after the last dose.

Drug: OBI-833/OBI-821

Interventions

OBI-833/OBI-821 DRUG

Cohort expansion phase; Dose escalation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ≥21 years of age
• 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
• 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
• Measurable disease (i.e., present with at least one measurable lesion per RECIST, version 1.1.
• 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
• Performance status: ECOG ≤ 1
• 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
• Subjects of child-bearing potential must agree to use acceptable contraceptive methods during treatment and until the end of the study. 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.
• Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.

You may not qualify if:

• Patients who have not received standard chemotherapy, hormonal or targeted therapy for their underlying advanced/metastatic cancer.
• Subjects who are pregnant or breast-feeding at entry.
• Subjects with splenectomy.
• Subjects with known or clinically manifest, symptomatic CNS metastases in Dose Escalation Phase.
• Subjects with HIV infection, active hepatitis B infection or active hepatitis C infection.
• 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.
• 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.
• 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
• Immunotherapy \[mAbs, Interferons, Cytokines (except GCSF)\]
• Immunosuppressants (e.g., cyclosporin, rapamycin, tacrolimus, rituximab, alemtuzumab, natalizumab, etc.).
• IV/oral steroids except single prophylactic use in CT/MRI scan or other one-time use in approved indications. The interval between IV/oral steroids administration and first dose of OBI-833/OBI-821 must be more than pharmacological duration or 5 half-lives of administered steroids, whichever is the longer. Uses of inhaled and topical use of steroids are allowed.
• Another investigational drug
• Cohort Expansion Phase: Subjects with any of the following MEDICATIONS within 4 weeks prior to IP treatment, except permitted therapies:

Sponsors & Collaborators

• OBI Pharma, Inc: lead

Study Sites (4)

Taipei Medical University Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Medical University Hospital

Taipei, 11031, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Stomach Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Chen-En Tsai, MD, PhD
• Organization: OBI Pharma, Inc.

chenentsai@obipharma.com

886 2 27866589

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: December 2, 2014
• First Posted: December 8, 2014
• Study Start: December 22, 2015
• Primary Completion: December 22, 2020
• Study Completion: February 2, 2021
• Last Updated: October 3, 2022
• Results First Posted: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)