A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 in Patients With Solid Tumors

Inclusion Criteria

• •Patient has histologically- or cytologically- confirmed metastatic or advanced-stage solid malignant tumor that is refractory to standard therapy and for whom no therapy exists that would be curative or might provide significant benefit and therefore for whom experimental therapy is a reasonable option.
• •Patient experienced progressive disease during or following or was intolerant of their most recent treatment regimen.
• •Patient is male or female aged ≥18 years.
• •Patient has an ECOG performance status of 0 (fully active, able to carry out all pre-disease activities without restriction) or 1 (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), as assessed on C1D1, before the first dose of TVB 2640.
• •Patient has adequate renal function (creatinine ≤1.5 times the upper limit of normal \[ULN\]) or a glomerular filtration rate (GFR) of ≥50 mL/min.
• •Patient has adequate hepatic function,
• •Patient has adequate bone marrow function
• •Patient has no significant ischemic heart disease or myocardial infarction (MI) within 6 months before the first dose of TVB 2640 and currently has adequate cardiac function
• •For the Monotherapy Expansion Cohorts of the Study ONLY:
• •Patient has a specific tumor-type and histology, as designated by the Sponsor based on nonclinical and clinical data obtained prior to enrollment in the Expansion Cohort.
• •Patient has measurable disease, as determined by the Investigator using RECIST, version 1.1 (1).
• •For the Combination Cohorts ONLY:
• •In addition to meeting monotherapy criteria above, the commercially-available anticancer agent of interest being investigated in combination with TVB-2640, administered according to the dose regimen in the prescribing information, is deemed appropriate for the patient's disease and clinical status.