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

Inclusion Criteria Include:

• 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.

Exclusion Criteria Include:

• Patient is unable to swallow oral medications or has impairment of GI function or GI disease that may significantly alter drug absorption
• Patient has uncontrolled or severe intercurrent medical condition (including uncontrolled brain metastases).
• Patient underwent major surgery within 4 weeks before the first dose of TVB 2640 or received cancer-directed therapy or an investigational drug or device within 4 weeks (6 weeks for mitomycin C and nitrosoureas) or 5 half-lives of that agent (whichever is shorter) before the first dose of TVB 2640.
• If female, patient is pregnant or breast-feeding.
• Patient has evidence of a serious active infection
• Patient has a history of other malignancy treated with curative intent within the previous 5 years with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.