Clinical Trials List
Protocol NumberPB-2018
2018-09-01 - 2020-02-29
Phase I
Recruiting2
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
A Phase I, open-label study to evaluate safety and tolerability of PB101 in combination with standard treatment, EGFR-TKI (Gefitinib or Erlotinib), in EGFR-mutated advanced non-small cell lung cancer.
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Trial Applicant
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Sponsor
精準生技股份有限公司
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Pai-Chien Chou Division of Thoracic Medicine
- 黃彥華 臺北醫學大學GTP核心實驗室主任
- Shih-Hsin Hsiao Division of Thoracic Medicine
- Chi-Li Chung Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
EGFR-mutated advanced non-small cell lung cancer
Objectives
To determine the safety and tolerability of PB101 in combination with standard of care EGFR-TKI (Gefitinib or Erlotinib) in patients with EGFR-mutated advanced non-small cell lung cancer.
Test Drug
PB101
Active Ingredient
NK/NKT cells
Dosage Form
I.V. Injection
Dosage
1x109＊, or 3x109＊cells （*allow ± 10% cell number )
Endpoints
Primary Endpoints:
Safety (Phase I) – to determine the dose of PB101 that can be given within dose-limiting toxicities.
Secondary Endpoints:
To observe the overall response rate(ORR), duration of response (DR) and progression-free survival(PFS).
Safety (Phase I) – to determine the dose of PB101 that can be given within dose-limiting toxicities.
Secondary Endpoints:
To observe the overall response rate(ORR), duration of response (DR) and progression-free survival(PFS).
Inclution Criteria
1. Main inclusion criteria:
1.1 Men and women 20 years of age or older.
1.2 Subjects with histologically or cytologically confirmed stage IIIB/IV non-small cell lung cancer, not amenable to definitive multi-modality therapy, or recurrent disease
after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/IASLC 7th edition proposed staging criteria.
1.3 EGFR sensitizing mutation must be detected in tumor tissue. Specifically, patients harboring the most common mutations, deletions in exon 19 or the L858R mutation in
exon 21 are eligible. Other EGFR sensitizing mutations may be eligible after discussion with the principal investigator.
1.4 Subjects must have measurable or evaluable disease according to RECIST v1.1.
1.5 Patients may have had a prior EGFR-TKI (gefitinib or erlotinib) in the metastatic setting, but treatment duration must have been less than three months at the time of
enrollment.
1.6. Patients may have had no more than one prior line of chemotherapy or immunotherapy in the metastatic setting. At least 14 days must have elapsed from the last
chemo/immunotherapy administration until the start of protocol treatment, and patients must have recovered from the side effects of any of these agents.
1.7 Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
1.8 Acceptable organ function, as evidenced by the following laboratory data:
(1). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN).
(for patients with known hepatic metastases, AST and/or ALT <5x ULN)
(2). Total serum bilirubin ≤1.5 x ULN
(3). Absolute neutrophil count (ANC) ≥1500 cells/mm3
(4). Platelet count ≥75,000 cells/mm3
(5). Hgb ≥ 10.0 g/dL
(6). Serum creatinine levels ≤ 1.5 * ULN, or calculated (by Cockcroft-Gault formula or
other accepted formula) or measure creatinine clearance ≥50 mL/min
1.1 Men and women 20 years of age or older.
1.2 Subjects with histologically or cytologically confirmed stage IIIB/IV non-small cell lung cancer, not amenable to definitive multi-modality therapy, or recurrent disease
after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/IASLC 7th edition proposed staging criteria.
1.3 EGFR sensitizing mutation must be detected in tumor tissue. Specifically, patients harboring the most common mutations, deletions in exon 19 or the L858R mutation in
exon 21 are eligible. Other EGFR sensitizing mutations may be eligible after discussion with the principal investigator.
1.4 Subjects must have measurable or evaluable disease according to RECIST v1.1.
1.5 Patients may have had a prior EGFR-TKI (gefitinib or erlotinib) in the metastatic setting, but treatment duration must have been less than three months at the time of
enrollment.
1.6. Patients may have had no more than one prior line of chemotherapy or immunotherapy in the metastatic setting. At least 14 days must have elapsed from the last
chemo/immunotherapy administration until the start of protocol treatment, and patients must have recovered from the side effects of any of these agents.
1.7 Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
1.8 Acceptable organ function, as evidenced by the following laboratory data:
(1). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN).
(for patients with known hepatic metastases, AST and/or ALT <5x ULN)
(2). Total serum bilirubin ≤1.5 x ULN
(3). Absolute neutrophil count (ANC) ≥1500 cells/mm3
(4). Platelet count ≥75,000 cells/mm3
(5). Hgb ≥ 10.0 g/dL
(6). Serum creatinine levels ≤ 1.5 * ULN, or calculated (by Cockcroft-Gault formula or
other accepted formula) or measure creatinine clearance ≥50 mL/min
Exclusion Criteria
2.1. Patients with history of clinically significant interstitial lung disease or radiation pneumonitis.
2.2. Patients with brain metastases or leptomeningeal disease.
2.3. Patients who have had radiation to the lung fields within four weeks of starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting to treatment.
2.4. Patients who have had major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within two weeks prior to starting study drug or who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and patients can be enrolled in the study ≥1 week after the procedure.
2.5. Patients with a second, clinically active, cancer. Patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed.
2.6. Known history of human immunodeficiency virus (HIV) seropositivity.
2.7. Participants who are receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least one week or five half-lives, whichever is longer, before starting treatment.
2.8. Patients receiving concomitant immunosuppressive agents or chronic corticosteroid use, except those on topical or inhaled steroids, or steroids given via local injection.
2.9. Patients with clinically significant, uncontrolled cardiovascular disease, such as: unstable angina or myocardial infarction within 6 months prior to screening, abnormal left ventricular ejection fraction (LVEF<50%), cardiac arrhythmia not controlled with medication, uncontrolled hypertension defined as a SBP≥ 160 mm Hg and/or DBP≥ 100 mm Hg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening.
2.10. Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management.
2.11 Pregnancy and lactating women.
2.12 Active hepatitis B or C without treatment.
2.13. Other situations the investigators think not eligible for participation in the research.
2.2. Patients with brain metastases or leptomeningeal disease.
2.3. Patients who have had radiation to the lung fields within four weeks of starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting to treatment.
2.4. Patients who have had major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within two weeks prior to starting study drug or who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and patients can be enrolled in the study ≥1 week after the procedure.
2.5. Patients with a second, clinically active, cancer. Patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed.
2.6. Known history of human immunodeficiency virus (HIV) seropositivity.
2.7. Participants who are receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least one week or five half-lives, whichever is longer, before starting treatment.
2.8. Patients receiving concomitant immunosuppressive agents or chronic corticosteroid use, except those on topical or inhaled steroids, or steroids given via local injection.
2.9. Patients with clinically significant, uncontrolled cardiovascular disease, such as: unstable angina or myocardial infarction within 6 months prior to screening, abnormal left ventricular ejection fraction (LVEF<50%), cardiac arrhythmia not controlled with medication, uncontrolled hypertension defined as a SBP≥ 160 mm Hg and/or DBP≥ 100 mm Hg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening.
2.10. Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management.
2.11 Pregnancy and lactating women.
2.12 Active hepatitis B or C without treatment.
2.13. Other situations the investigators think not eligible for participation in the research.
The Estimated Number of Participants
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Taiwan
12 participants
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Global
0 participants
