Overview
Subjects will undergo baseline evaluation and an assessment of extent of disease.
Subjects in Part 1 (Dose Escalation) will receive escalating doses of CB-03-10 based on a modified Fibonacci schema using a standard oncology 3+3 study design to define an MTD and a RP2D. Plasma PK samples will be collected at predetermined timepoints for all subjects.
Subjects in Part 2 (Dose Expansion) of the study will receive CB-03-10 at the RP2D determined in the Part 1 of the study. The indications included in each group will be determined at the completion of Part 1 of the study by Safety Review Committee (SRC).
Subjects will be evaluated weekly initially (for 2 cycles in Part 1 and for 1 cycle in Part 2) and every 2 weeks thereafter. Reassessment of disease will be conducted at Week 8 and every 8 weeks thereafter. Subjects with evidence of response (partial or complete) will be re-evaluated at least 4 weeks later for confirmation.
Description
Subjects will undergo baseline evaluation and an assessment of extent of disease.
Subjects in Part 1 (Dose Escalation) will receive escalating doses of CB-03-10 based on a modified Fibonacci schema using a standard oncology 3+3 study design to define an MTD and a RP2D. Plasma PK samples will be collected at predetermined timepoints for all subjects.
Subjects in Part 2 (Dose Expansion) of the study will receive CB-03-10 at the RP2D determined in the Part 1 of the study. The indications included in each group will be determined at the completion of Part 1 of the study by Safety Review Committee (SRC).
Subjects will be evaluated weekly initially (for 2 cycles in Part 1 and for 1 cycle in Part 2) and every 2 weeks thereafter. Reassessment of disease will be conducted at Week 8 and every 8 weeks thereafter. Subjects with evidence of response (partial or complete) will be re-evaluated at least 4 weeks later for confirmation.
Eligibility
INCLUSION CRITERIA:
Signed informed consent For Part 1 (Dose Escalation): Histologically or cytologically
confirmed relapsed or refractory locally advanced or metastatic solid tumor, not amenable
to standard therapy For Part 2 (Dose Expansion): Histologically or cytologically confirmed
relapsed or refractory locally advanced or metastatic solid tumor limited to a specific
tumor subtype as determined by the SRC Age >18 years Eastern Cooperative Oncology Group
(ECOG) performance status ≤ 2 For Part 1 (Dose Escalation): Measurable or evaluable disease
as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria For Part
2 (Dose Expansion): Measurable disease as per RECIST v1.1 criteria. Adequate renal, hepatic
and bone marrow function as defined by Screening labs Negative pregnancy test for females
of childbearing potential at the Screening Visit and use of appropriate method of birth
control.
EXCLUSION CRITERIA Pregnant or breastfeeding women Known central nervous system (CNS)
metastases or spinal cord compression Known second cancer of other primary origin
(excluding Stage I non-melanoma skin cancer and prostate cancer controlled with hormonal
therapy) within the prior 5 years Active autoimmune disease Significant cardiac disease
Uncontrolled hypertension Major surgery or irradiation within 28 days prior to start of
study treatment Fewer than 28 days (or fewer than 5 half-lives, whichever is shorter) from
prior anticancer therapy Requirement for chronic corticosteroids or other immunosuppressant
drugs Known infection with hepatitis B or C virus Known infection with HIV and CD4+ T-cell
counts < 350 cells/uL Patients with an opportunistic infection within the past 12 months.