Actively Recruiting
Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors
Led by Cosmo Technologies Ltd · Updated on 2024-02-07
90
Participants Needed
6
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Histologically or cytologically confirmed relapsed or refractory locally advanced or metastatic solid tumor (not responding to standard therapy for Part 1)
- Histologically or cytologically confirmed relapsed or refractory locally advanced or metastatic solid tumor limited to a specific subtype as determined by Safety Review Committee for Part 2
- Age greater than 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Measurable or evaluable disease as defined by RECIST v1.1 criteria for Part 1
- Measurable disease as per RECIST v1.1 criteria for Part 2
- Adequate kidney, liver, and bone marrow function based on screening labs
- Negative pregnancy test for females of childbearing potential at screening and use of effective birth control
You will not qualify if you...
- Pregnant or breastfeeding women
- Known central nervous system (CNS) metastases or spinal cord compression
- Known second cancer of other primary origin (except Stage I non-melanoma skin cancer and prostate cancer controlled with hormonal therapy) within past 5 years
- Active autoimmune disease
- Significant heart disease
- Uncontrolled high blood pressure
- Major surgery or radiation therapy within 28 days before starting study treatment
- Less than 28 days (or fewer than 5 half-lives, whichever is shorter) since 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 below 350 cells/uL
- History of opportunistic infection within past 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University of California Irvine Health Chao Family Comprehensive Cancer Center
California City, California, United States, 92868
Actively Recruiting
2
University of Colorado Cancer Center
Colorado Springs, Colorado, United States, 80045
Actively Recruiting
3
Yale Cancer Center
New Haven, Connecticut, United States, 208028
Actively Recruiting
4
Barbara Ann Karmanos Cancer Institute
Michigan Center, Michigan, United States, 48201
Actively Recruiting
5
Gabrail Cancer Center
Ohio City, Ohio, United States, 44718
Actively Recruiting
6
Tranquil Clinical Research
Texas City, Texas, United States, 77598
Actively Recruiting
Research Team
C
Cristina Banyai
CONTACT
M
Mara Gerloni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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