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NCT03863145 | RECRUITING | Advanced Refractory Solid Tumors

Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors
Sponsor:

Cosmo Technologies Ltd

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 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.

Condition or disease

Advanced Refractory Solid Tumors

Subjects Considered Likely to Respond to CB-03-10

Intervention/treatment

CB-03-10

Phase

EARLY_PHASE1

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 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 90 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Open Label, Multicenter, Phase 1 Study to Evaluate the Maximum Tolerated Dose of Orally Administered CB-03-10 With Dose Expansion Phase, in Subjects With Advanced Solid Tumors
Actual Study Start Date : 2022-06-14
Estimated Primary Completion Date : 2026-01-01
Estimated Study Completion Date : 2026-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors

Location Details

NCT03863145

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of California Irvine Health Chao Family Comprehensive Cancer Center

California City, California, United States, 92868

RECRUITING

United States, Colorado

University of Colorado Cancer Center

Colorado Springs, Colorado, United States, 80045

RECRUITING

United States, Connecticut

Yale Cancer Center

New Haven, Connecticut, United States, 208028

RECRUITING

United States, road cancer

Barbara Ann Karmanos Cancer Institute

Michigan Center, road cancer, United States, 48201

RECRUITING

United States, Ohio

Gabrail Cancer Center

Ohio City, Ohio, United States, 44718

RECRUITING

United States, Texas

Tranquil Clinical Research

Texas City, Texas, United States, 77598