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A Study Assessing the Interchangeability Between TRS003 and Bevacizumab® For CRC

NCT05378867 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2022-05-18

No results posted yet for this study

Summary

This is a Phase 3, multicenter, randomized and double-blind study assessing the interchangeability between TRS003 and China-approved Bevacizumab® (also called China-approved Avastin) for first-line treatment of patients with metastatic Colorectal Cancer (CRC), approximately 126 patients will be enrolled in this study. Patients who sign the informed consent, meet the eligibility criteria and are confirmed as non-progressors after lead-in treatment period with Bevacizumab® in combination with modified FOLFOX6 chemotherapy for 6 cycles, will be randomized (1:1) to either the non-switching arm and receive Bevacizumab® + modified FOLFOX6 for all subsequent cycles or to the switching arm and receive TRS003 alternating with Bevacizumab® in combination with mFOLFOX6 until disease progression or intolerability.

Conditions

  • Metastatic Colorectal Cancer (CRC)

Interventions

BIOLOGICAL

TRS003

* TRS003, 5 mg/kg IV every 14 days with mFOLFOX6 for 1 cycle followed by switch to: * Bevacizumab®, 5 mg/kg IV every 14 days with mFOLFOX6 for 1 cycle followed by switch to: * TRS003, 5 mg/kg IV every 14 days with mFOLFOX6 until end of treatment due to PD, intolerability or other cause for stopping treatment. Intensive PK sampling will be performed after 7 cycles of this TRS003 switch period

BIOLOGICAL

China-approved Bevacizumab

• Bevacizumab®, 5 mg/kg IV every 14 days with mFOLFOX6 for 1 cycle

DRUG

mFOLFOX6

The mFOLFOX6 regimen is: * Oxaliplatin, 85 mg/m2 administered IV over 2 hours * LCV, 400 mg/m2 administered over 2 hours concurrent with oxaliplatin * 5-FU, 400 mg/m2 given as a slow IV push (bolus) over 5 minutes administered immediately after LCV * 5-FU, 2400 mg/m2 administered IV over 46 hours by infusion pump beginning immediately after FU IV bolus.

Sponsors & Collaborators

  • Zhejiang Teruisi Pharmaceutical Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-10-01
Completion
2024-07-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378867 on ClinicalTrials.gov