A Randomized, Open-Label, Phase 2 Study 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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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.

⁃ Understand and provide a written informed consent document according to institutional guidelines.

Locations
Other Locations
Taiwan
Shuang Ho Hospital
RECRUITING
New Taipei City
Taichung Veterans General Hospital
RECRUITING
Taichung
National Taiwan University Cancer Center
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Tri-Service General Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Contact Information
Primary
Anna Hu
annahu@obipharma.com
886-2-27866589
Backup
Lance Ou
lou@obipharma.com
886-2-27866589
Time Frame
Start Date: 2022-07-27
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 60
Treatments
Active_comparator: Erlotinib
Erlotinib (150 mg daily)
Experimental: Erlotinib + OBI-833/OBI-821
Erlotinib (150 mg daily) + 30 μg OBI-833/100 μg OBI-821
Sponsors
Leads: OBI Pharma, Inc

This content was sourced from clinicaltrials.gov