Status and phase
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About
This is a multicenter, open-label, Phase 1/2, dose-escalation and dose expansion study of a CXCR4 inhibitor, USL311, alone and in combination with lomustine in subjects with advanced solid tumors (Phase 1) and subjects with relapsed/recurrent GBM (Phase 2). The study is designed to explore the safety, tolerability, pharmacokinetics, and preliminary efficacy of USL311 alone and in combination with lomustine.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
All Subjects:
Provide signed and dated informed consent prior to study-specific screening procedures
≥ 18 years old
Karnofsky performance status (KPS) ≥ 70
Must have adequate bone marrow and renal/hepatic function within protocol specified limits
Disease-free period of > 2 years from any other previous malignancies, excluding curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. Subjects with prostate cancer Stage 1 that do not require treatment may also be included
Women and men must use protocol approved methods of contraception
Must be able and willing to comply with the study visit schedule and study procedures
Must be able to take oral medications
Must have available archived tumor tissue and willing and able to provide consent for study access to such tissue
For subjects with a history of seizures, must be adequately controlled on a stable regimen of anti-epileptic drugs
For Phase 1 Subjects Only:
Histologically or cytologically documented diagnosis of solid tumor for which no standard therapy is recognized or have failed or intolerant to the standard-of-care treatment
Inoperable metastatic or locally advanced, unresectable disease
Subjects may have either evaluable or measurable disease
Subjects with treated (surgically excised or irradiated) and stable brain metastases are eligible as long as the subject has adequately recovered from treatment and the treatment was ≥ 28 days prior to initiation of study drug(s) and baseline brain computed tomography (CT) with contrast or magnetic resonance imaging (MRI) ≤ 14 days of initiation of study drug is negative for new brain metastases
For Phase 2 Subjects Only:
Histologically confirmed diagnosis of GBM
Subjects must have documented recurrence after first-line treatment
Prior first-line treatment must have included radiation and temozolomide
Subject is suitable for re-resection, per Investigator discretion, as a component of their clinical care
No more than one prior resection (Note: biopsy does not count as prior resection)
Exclusion criteria
All Subjects
Subjects who have had recent systemic anticancer therapies, interventional device treatment and/or radiotherapy either within 14 days prior to first dose of study drug(s) or have not recovered (to grade ≤ 1) from all clinically significant toxicities related to prior therapies
Subjects who have had any major surgery (not including re-resection surgery required in Phase 2) within 28 days prior to first dose of study drug(s), or minor surgery within 14 days prior to first day of study drug(s)
Subjects taking any strong cytochrome P450 3A4 inducers within 14 days prior to the first dose of study drug(s)
Subjects taking any strong cytochrome P450 3A4 inhibitors within 14 days prior to the first dose of study drug(s)
Subjects taking any agents with moderate to high risk to prolong QT corrected (QTc) interval or to cause Torsades de Pointes within 14 days prior to the first dose of study drug(s)
Subjects who have been treated with an investigational agent or investigational interventional device within 21 days prior to the first dose of study drug(s)
Subject is growth factor dependent or transfusion dependent, or has received growth factor support or transfusion support within 14 days prior to the first dose of study drug(s)
History of significant cardiac disease
Status epilepticus within 1 year prior to the first dose of study drug(s)
Pregnant or breastfeeding
Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation
For Phase 1 Subjects Only:
Lymphoma as primary cancer
For Phase 2 Subjects Only:
Unable or unwilling to consent to the provision of resected tissue after surgery
Prior treatment with plerixafor or another CXCR4 inhibitor
Prior treatment with bevacizumab
Prior treatment with lomustine and/or carmustine
For All Cohorts Receiving Oral USL311:
Any active medical condition or previous major abdominal surgery or procedure that might, in the investigator's opinion, have a significant effect on USL311 absorption
Primary purpose
Allocation
Interventional model
Masking
26 participants in 5 patient groups
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Data sourced from clinicaltrials.gov
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