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ACTIVE NOT RECRUITING 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

NCT05609370 · View on ClinicalTrials.gov ↗

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

91 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05609370

The ClinicalTrials.gov registry entry for NCT05609370 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 91 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05609370 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Kentucky, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05609370?

This trial is sponsored by BeiGene, which has 91 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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