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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 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. The trial reports 20 study locations across 11 states.

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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.

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

FieldValue
Enrollment Target 113 participants
Start Date 2023-01-29
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

BeiGene

65 total trials

What the Registry Record Tells You About NCT05609370

The ClinicalTrials.gov registry entry for NCT05609370 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BeiGene, which has 65 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.