Status:
RECRUITING
Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors
Lead Sponsor:
Cosmo Technologies Ltd
Conditions:
Advanced Refractory Solid Tumors
Subjects Considered Likely to Respond to CB-03-10
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 u...
Detailed 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 u...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03863145
Start Date
June 14 2022
End Date
June 1 2026
Last Update
February 7 2024
Active Locations (6)
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1
University of California Irvine Health Chao Family Comprehensive Cancer Center
California City, California, United States, 92868
2
University of Colorado Cancer Center
Colorado Springs, Colorado, United States, 80045
3
Yale Cancer Center
New Haven, Connecticut, United States, 208028
4
Barbara Ann Karmanos Cancer Institute
Michigan Center, Michigan, United States, 48201