Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Early Phase 1 study of Advanced Refractory Solid Tumors and Subjects Considered Likely to Respond to CB-03-10, sponsored by Cosmo Technologies.
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, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT03863145 shows while recruiting
NCT03863145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% higher).
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 lists 6 locations in 6 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03863145's enrollment target sits among peer trials
90 233rd of 2000 higher than 1,753 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02521311 · 90 participants · Phase 2
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
- NCT02939573 · 90 participants · Phase 2
A Randomized Multicenter Study for Isolated Skin Vasculitis
- NCT03128879 · 90 participants · Phase 2
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
- NCT03184038 · 90 participants · NA
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI