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NCT03863145 · ClinicalTrials.gov registry record · Early Phase 1
Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors
A Early Phase 1 study of Advanced Refractory Solid Tumors and Subjects Considered Likely to Respond to CB-03-10, sponsored by Cosmo Technologies.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 90
- Enrollment target
- 6
- Study locations
NCT03863145 is a Early Phase 1 study of Advanced Refractory Solid Tumors and Subjects Considered Likely to Respond to CB-03-10 that is actively recruiting participants, run by Cosmo Technologies. The registered enrollment target is 90 participants. The trial reports 6 study locations across 6 states.
The verdict
NCT03863145, a Early Phase 1 study of Advanced Refractory Solid Tumors and Subjects Considered Likely to Respond to CB-03-10, is actively recruiting participants, sponsored by Cosmo Technologies.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 90 participants
- Enrollment target
- 6
- Study locations
Study 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 Studied
Interventions
- DRUG CB-03-10
Study Locations (6)
California
- University of California Irvine Health Chao Family Comprehensive Cancer Center - California City
Colorado
- University of Colorado Cancer Center - Colorado Springs
Connecticut
- Yale Cancer Center - New Haven
Michigan
- Barbara Ann Karmanos Cancer Institute - Michigan Center
Ohio
- Gabrail Cancer Center - Ohio City
Texas
- Tranquil Clinical Research - Texas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2022-06-14 |
| Est. Completion | 2026-06-01 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03863145
The ClinicalTrials.gov registry entry for NCT03863145 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cosmo Technologies, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Advanced Refractory Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which CB-03-10 is the first listed.
NCT03863145 reports 6 study locations spanning 6 distinct geographic areas - top geographies include California, Colorado, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03863145 about?
NCT03863145 is a clinical study titled "Study to Evaluate Maximum Tolerated Dose of Oral CB-03-10 With Dose Expansion Phase, in Advanced Solid Tumors". 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 col...
What is the current status of trial NCT03863145?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 90 participants. The study started on 2022-06-14. Estimated completion is 2026-06-01.
What conditions does trial NCT03863145 study?
This clinical trial studies the following conditions: Advanced Refractory Solid Tumors, Subjects Considered Likely to Respond to CB-03-10.
What interventions are being tested in trial NCT03863145?
The interventions under investigation include: CB-03-10 (DRUG).
Who is sponsoring clinical trial NCT03863145?
This trial is sponsored by Cosmo Technologies, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03863145 being conducted?
This trial has 6 study locations across California, Colorado, Connecticut, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Advanced Refractory Solid Tumors
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