A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer (NCT05141357) | Clinical Trial Compass
TerminatedPhase 2
A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer
Stopped: Slow Recruitment
United States5 participantsStarted 2022-02-15
Plain-language summary
A Phase 2 Study to Assess the Safety and Efficacy of HBI-8000 in Combination with Pembrolizumab for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adults at least 18 years of age.
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
✓. Histopathologically confirmed diagnosis of NSCLC PD-L1 expression TPS ≥1% as determined by an FDA-approved test.
✓. Have at least one measurable target lesion as defined by RECIST v.1.1.
✓. Have not received immune checkpoint inhibitor therapy or more than one regimen of chemotherapy for advanced or metastatic disease. Subjects who have previously received immune checkpoint inhibitor therapy in the adjuvant or neoadjuvant setting may be allowed if disease progression occurred \>6 months after the last dose and no clinically significant immune related toxicities leading to treatment discontinuation were observed.
✓. Prior adjuvant or neoadjuvant systemic therapy with chemotherapy, EGFR or ALK mutation directed therapy must have been completed \>4 weeks before Cycle 1 Day 1 (C1D1) dosing and recovered from all treatment related toxicity.
✓. Any prior palliative radiotherapy or minor surgery must be completed at least 2 weeks and 1 week respectively before C1D1 dosing and recovered from all treatment related toxicities.
✓. Adequate major organ functions at baseline as evidenced by laboratory findings within 14 days prior to C1D1 study drug administration as defined below:
Exclusion criteria
✕. History of Grade ≥3 hypersensitivity reactions to monoclonal antibodies.
✕
What they're measuring
1
Safety and Tolerability of HBI-8000 When Administered in Combination With Standard Dose and Regimen of Pembrolizumab
Timeframe: From the start of treatment until 30 days after the last dose of HBI-8000, up to approximately 13 months
. History of a cardiovascular illness including: QT interval corrected by heart rate using Fridericia's correction formula (QTcF) \>450 ms in male or \>470 ms in female, congenital long QT syndrome, congestive heart failure (New York Heart Association Grade III or IV) (Protocol Appendix 2); unstable angina or myocardial infarction within the previous 6 months; or symptomatic cardiac arrhythmia despite medical management.
✕. Central nervous system metastasis or leptomeningeal disease except when treatment for brain metastasis is completed \>14 days prior to C1D1 and stable for ≥4 weeks on \<10 mg daily prednisone or equivalent.
✕. History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled peptic ulcer disease or bowel resection that affects absorption of orally administered drugs.
✕. Recurrent pleural effusion requiring repetitive palliative thoracentesis within 3 months prior to study entry, except for subjects with a pleurex port.
✕. Active, known, or suspected autoimmune disease, or history of immune-mediated toxicity leading to treatment discontinuation, except for type I diabetes mellitus, hypothyroidism only requiring hormone replacement or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic therapy.
✕. Active pneumonitis, history of non-infectious pneumonitis that required treatment with steroids, or history of interstitial lung disease.