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This study is an an open-label Phase I trial of VT1021 in patients with advanced solid tumors. Patients must have recurrent or advanced cancer (i.e., solid tumors) for which standard therapy offers no curative potential.
Full description
This is an open-label Phase I study of VT1021 in patients with advanced solid tumors. The study will include a Dose Escalation Phase and a Dose Expansion Phase. Upon determination of the Recommended Phase 2 Dose in the Dose Escalation Phase, the Dose Expansion Phase will be opened. The Dose Expansion Phase will include cohorts in ovarian, pancreatic, triple negative breast cancer, glioblastoma and CD36-high patients in order to confirm the tolerability of VT1021 against specific tumor types.
Enrollment
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Inclusion criteria
Dose Escalation Phase:
Patients must be refractory to, or intolerant of, existing therapies known to provide clinical benefit for their condition (i.e., cancer diagnosis)
Dose Expansion Phase:
Ovarian:
Patients with confirmed diagnosis of unresectable epithelial ovarian, fallopian tube, or primary peritoneal cancer must have received ≤ 3 prior lines of therapy in a platinum resistant setting. BRCA mutant patients are excluded unless they have failed previous line with a PARP inhibitor
Pancreatic:
Patients with confirmed diagnosis of pancreatic cancer must have received ≤2 prior lines of therapy
Triple Negative Breast Cancer:
Patients with confirmed diagnosis of metastatic TNBC must have received ≤ 3 prior lines of therapy for metastatic disease
Glioblastoma:
Patients with confirmed relapsed or refractory glioblastoma must have received ≤2 prior lines of systemic therapy
CD36-high basket cohort:
Patients with solid tumor cancers that have high expression of CD36 by immunohistochemistry. Patients must have received ≤ 3 prior lines of therapy for metastatic disease
Patient has evaluable disease by RECIST v1.1
Patient has a performance status (PS) of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
Patient is at least 21 days (12 weeks for glioblastoma patients) removed from therapeutic radiation or chemotherapy prior to the first scheduled day of dosing with VT1021
Patient has adequate organ function
Patient agrees to use acceptable methods of contraception during the study and 60 days after the last dose of VT1021
Exclusion criteria
Primary purpose
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116 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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