Evaluating a new oral medication for advanced solid tumors
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
This study is testing a new oral medication for people with advanced solid tumors to find the highest safe dose and see how well it works.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cosmo Pharmaceuticals NV Industry-sponsored |
| Locations | 6 sites (California City, California and 5 other locations) |
| Trial ID | NCT03863145 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the maximum tolerated dose of an oral medication called CB-03-10 in patients with advanced refractory solid tumors. The study is divided into two parts: the first part involves dose escalation using a modified Fibonacci schema to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). In the second part, participants will receive the RP2D of CB-03-10, with ongoing evaluations of their disease status and response to treatment. The trial includes regular assessments and plasma sample collections to monitor drug levels and effects.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with histologically or cytologically confirmed relapsed or refractory locally advanced or metastatic solid tumors.
Not a fit: Patients with tumors amenable to standard therapies or those with certain central nervous system conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that are resistant to standard therapies.
How similar studies have performed: While this approach is not widely tested, similar dose escalation studies have shown promise in oncology, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
California City, California and 5 other locations
- University of California Irvine Health Chao Family Comprehensive Cancer Center — California City, California, United States (Recruiting)
- University of Colorado Cancer Center — Colorado Springs, Colorado, United States (Recruiting)
- Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
- Barbara Ann Karmanos Cancer Institute — Michigan Center, Michigan, United States (Recruiting)
- Gabrail Cancer Center — Ohio City, Ohio, United States (Recruiting)
- Tranquil Clinical Research — Texas City, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Cristina Banyai
- Email: cbanyai@cosmopharma.com
- Phone: +353867015703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.