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NCT05609370 · ClinicalTrials.gov registry record · Phase 1
A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer
A Phase 1 study of Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer, sponsored by BeiGene.
- Active
- Registry status
- Phase 1
- Development phase
- 113
- Enrollment target
- 20
- Study locations
NCT05609370: Active Phase 1 study of Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer, sponsored by BeiGene.
NCT05609370 is a Phase 1 study of Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer that is active but no longer recruiting, run by BeiGene. The registered enrollment target is 113 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05609370, a Phase 1 study of Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer, is active but no longer recruiting, sponsored by BeiGene.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 113 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 1b/2 study to investigate the efficacy and safety of LBL-007 plus tislelizumab when administered in combination with bevacizumab plus fluoropyrimidine, and LBL-007 in combination with bevacizumab plus fluoropyrimidine versus bevacizumab plus fluoropyrimidine to participants with colorectal cancer.
Primary Outcome
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not. A serious AE (SAE) was any untoward medical occurrence that, at any dose- * resulted in death, * was life threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, * was a congenital
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Tislelizumab
- DRUG 5-Fluorouracil
- DRUG LBL-007
- DRUG Bevacizumab or Bevacizumab biosimilar
Study Locations (20)
California
- Toi Clinical Research - Cerritos
- Usc Norris Comprehensive Cancer Center (Nccc) - Los Angeles
- Valkyrie Clinical Trials - Los Angeles
- UCLA - Los Angeles
- Hoag Memorial Presbyterian - Newport
- Kaiser Permanente Northern California - Vallejo
Kentucky
- Baptist Health Lexington - Lexington
- University of Kentucky Markey Cancer Center - Lexington
- Norton Cancer Institute - Louisville
Louisiana
- Pontchartrain Cancer Center - Covington
- Ochsner Clinic Foundation - New Orleans
Nevada
- Comprehensive Cancer Centers of Nevada - Las Vegas
- Cancer Care Specialists - Reno
Alaska
- Alaska Oncology and Hematology, Llc - Anchorage
Arizona
- Banner Md Anderson Cancer Center - Gilbert
Florida
- Baptist Md Anderson Cancer Center - Jacksonville
Indiana
- Fort Wayne Medical Oncology and Hematology - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2023-01-29 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT05609370 still lists
NCT05609370 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% higher).
The record links to 1 condition, with Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT05609370 names 20 study sites across 11 states, led by California, Kentucky, Louisiana.
Frequently Asked Questions
What is clinical trial NCT05609370 about?
NCT05609370 is a clinical study titled "A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer". This is a Phase 1b/2 study to investigate the efficacy and safety of LBL-007 plus tislelizumab when administered in combination with bevacizumab plus fluoropyrimidine, and LBL-007 in combination with bevacizumab plus fluoropyrimidine versus bevacizumab plus fluoropyrimidine to participants with colo...
What is the current status of trial NCT05609370?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 113 participants. The study started on 2023-01-29. Estimated completion is 2026-12-31.
What conditions does trial NCT05609370 study?
This clinical trial studies the following conditions: Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer.
What interventions are being tested in trial NCT05609370?
The interventions under investigation include: Capecitabine (DRUG), Tislelizumab (DRUG), 5-Fluorouracil (DRUG), LBL-007 (DRUG), Bevacizumab or Bevacizumab biosimilar (DRUG).
Who is sponsoring clinical trial NCT05609370?
This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05609370 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05609370's enrollment target sits among peer trials
113 508th of 2000 higher than 1,493 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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
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