Recruiting
Early Phase 1

CB-03-10

Sponsor:

Cosmo Technologies Ltd

Code:

NCT03863145

Conditions

Advanced Refractory Solid Tumors

Subjects Considered Likely to Respond to CB-03-10

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CB-03-10

Study Details

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.

Conditions

Advanced Refractory Solid Tumors

Subjects Considered Likely to Respond to CB-03-10

Study ID

NCT03863145

Start date

Jun 14, 2022

Status verified date

Feb, 2024

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

Part 1 (Dose Escalation): 100 mg daily.

Interventions

CB-03-10

CB-03-10, 100 mg capsule for oral use

Primary outcome measure

  • Determine the maximum tolerated dose [ Time Frame: 29 days ]
  • Determine the dose-limiting toxicity [ Time Frame: 28 days ]

Central Contacts and Locations

Locations

University of California Irvine Health Chao Family Comprehensive Cancer Center

Recruiting

California City, California, United States, 92868

University of Colorado Cancer Center

Recruiting

Colorado Springs, Colorado, United States, 80045

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 208028

Barbara Ann Karmanos Cancer Institute

Recruiting

Michigan Center, Michigan, United States, 48201

Gabrail Cancer Center

Recruiting

Ohio City, Ohio, United States, 44718

Tranquil Clinical Research

Recruiting

Texas City, Texas, United States, 77598

More Information

Sponsor

Cosmo Technologies Ltd

Last update posted

Feb 7, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cosmo Technologies Ltd on 2024-02-07.