To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT05442060 | Recruiting Phase 2 DMC

• 1 other identifier: OBI-833-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

This study is a randomized, active control, open-label, phase 2 trial. Erlotinib-treated NSCLC patients will be screened for Globo H, and only Globo H+ (H score ≥ 100) subjects are eligible for the study. Eligible subjects who have been treated with 3±1 months of first-line erlotinib and have achieved stable disease (SD) or partial response (PR) status will be randomized in the ratio of 1:1 to receive erlotinib alone or erlotinib plus OBI-833/OBI-821 therapy.

Conditions

Non-small Cell Lung Cancer

Keywords

OBI-833/OBI-821; Erlotinib; EGFR-Mutated; Globo H; Globo H positive; Locally advanced non-small cell lung cancer; Metastatic non-small cell lung cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression-free survival rated at one year

  One year progression-free survival rated by RECIST 1.1 criteria

  One year

Study Arms (2)

Erlotinib

ACTIVE COMPARATOR

Erlotinib (150 mg daily)

Drug: Erlotinib (150 mg daily)

Erlotinib + OBI-833/OBI-821

EXPERIMENTAL

Erlotinib (150 mg daily) + 30 μg OBI-833/100 μg OBI-821

Biological: 30 μg OBI-833/100 μg OBI-821; Drug: Erlotinib (150 mg daily)

Interventions

30 μg OBI-833/100 μg OBI-821 BIOLOGICAL

Each subject in the OBI-833/OBI-821 + erlotinib combination arm will be treated with OBI-833/OBI-821 weekly for 4 doses (Weeks 1, 2, 3, 4), then every 2 weeks for 2 doses (Weeks 6, 8), then every 4 weeks for 4 doses (Weeks 12, 16, 20, 24), and then every 8 weeks until documented disease progression, intolerable adverse events (AEs)/toxicity, consent withdrawal, death, loss to follow-up, or up to 80 weeks from randomization.

Erlotinib + OBI-833/OBI-821

Erlotinib (150 mg daily) DRUG

All subjects in both arms will continue to receive erlotinib as the background therapy (150 mg daily).

Erlotinib; Erlotinib + OBI-833/OBI-821

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 20 years.
• Pathologically or cytologically confirmed diagnosis of non-small cell lung cancer whose stage is IIIB, IIIC, IVA, or IVB according to the AJCC Cancer Staging System, 8th Edition.
• The tumor harbors an exon 19 deletion or exon 21 L858R mutation in EGFR, confirmed locally.
• Patient must have a documented Globo H H-score of at least 100 using a validated central IHC assay.
• Patient must have received 3±1 months of first-line erlotinib therapy under a stable dosage of 150 mg/day, have achieved SD or PR before randomization (as confirmed by the Investigator), and plan to continue the erlotinib treatment at 150 mg/day.
• At least one measurable tumor lesion according to RECIST version 1.1 as assessed by the Investigator (local radiological image assessment).
• Life expectancy ≥ 6 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 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 in the presence of liver metastases
• Total bilirubin ≤ 2.0 X ULN
• Serum creatinine ≤ 1.5X ULN
• ANC ≥ 1,500 /µL
• Platelets ≥ 100,000/µL
• All eligible patients of childbearing potential must use effective contraception during study treatment, and for at least 2 months after the last dose of OBI-833/OBI-821 and for at least 2 weeks after the last dose of erlotinib. Subjects not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in the study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.

You may not qualify if:

• Patient who has CNS metastasis.
• Patient who is pregnant or breast-feeding at entry.
• Patient with splenectomy.
• Patient with HIV infection, active hepatitis B infection, or active hepatitis C infection.
• Patient with a positive test result for SARS-CoV-2 detected by standard reverse transcription-polymerase chain reaction (RT-PCR) at screening.
• Patient with any autoimmune or other disorders requiring IV/oral steroids or immunosuppressive or immunomodulatory therapies.
• (e.g., type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Graves disease, Hashimoto thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, Crohn disease, ulcerative colitis, and psoriasis).
• A history of other malignancies (except non-melanoma skin carcinoma, carcinoma in situ of the uterine cervix, follicular or papillary thyroid cancer) within 5 years prior to randomization.
• Patient with any known uncontrolled comorbid 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.
• Treatment with any of the following therapies within 4 weeks prior to randomization:
• Anti-cancer therapies, including chemotherapy and targeted therapy (except erlotinib).
• Radiotherapy.
• Immunotherapy, including monoclonal antibodies, cytokines, interferons, and checkpoint inhibitors.
• Immunosuppressants, including cyclosporin, rapamycin, tacrolimus, rituximab, alemtuzumab, natalizumab, and cyclophosphamide.
• Other biologics, including G-CSF and other hematopoietic growth factors.

Sponsors & Collaborators

• OBI Pharma, Inc: lead

Study Sites (7)

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

RECRUITING

National Taiwan University Cancer Center

Taipei, Da'an Dist., 106, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan District, Guishan Dist., 333, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, Neihu District, 114202, Taiwan

RECRUITING

Shuang Ho Hospital

New Taipei City, Zhonghe District, 23561, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Zhongzheng Dist., 100229, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lance Ou

  OBI Pharma, Inc

  STUDY DIRECTOR

Central Study Contacts

Anna Hu

CONTACT

886-2-27866589; annahu@obipharma.com

Lance Ou

CONTACT

886-2-27866589; lou@obipharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: July 27, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (7)