Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Phase 1/2 Study of USL311 Alone and in Combination With Lomustine in Subjects With Advanced Solid Tumors and Relapsed/Recurrent Glioblastoma Multiforme (GBM)

Summary: 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.


Eligibility: Inclusion Criteria:
  All Subjects:
  1. Provide signed and dated informed consent prior to study-specific screening procedures
  2. ≥ 18 years old
  3. Karnofsky performance status (KPS) ≥ 70
  4. Must have adequate bone marrow and renal/hepatic function within protocol specified limits
  5. 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
  6. Women and men must use protocol approved methods of contraception
  7. Must be able and willing to comply with the study visit schedule and study procedures
  8. Must have available archived tumor tissue and willing and able to provide consent for study access to such tissue
  For Phase 1 Subjects Only:
  9. 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
  10. Inoperable metastatic or locally advanced, unresectable disease
  11. Subjects may have either evaluable or measurable disease
  12. 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:
  13. Histologically confirmed diagnosis of GBM
  14. Subjects must have documented recurrence after first-line treatment
  15. Prior first-line treatment must have included radiation and temozolomide
  16. Subject is suitable for re-resection, per Investigator discretion, as a component of their clinical care
  17. No more than one prior resection (Note: biopsy does not count as prior resection)
  Exclusion Criteria:
  All Subjects
  1. 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
  2. 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)
  3. Subjects taking any protocol prohibited medications within 14 days prior to initiating study drug(s) treatment
  4. 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)
  5. History of significant cardiac disease
  6. Pregnant or breastfeeding
  7. Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation
  For Phase 1 Subjects Only:
  8. Subjects with lymphoma as primary cancer
  For Phase 2 Subjects Only:
  9. Subjects unable or unwilling to consent to the provision of resected tissue after surgery

Relevance to patient case: not relevant