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

Sponsor
Zhejiang Teruisi Pharmaceutical Inc.
Study ID
NCT05378867
Phase
PHASE3
Status
Unknown

Conditions

  • Metastatic Colorectal Cancer (CRC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TRS003 — BIOLOGICAL
    * 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
  • China-approved Bevacizumab — BIOLOGICAL
    • Bevacizumab®, 5 mg/kg IV every 14 days with mFOLFOX6 for 1 cycle
  • mFOLFOX6 — DRUG
    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.

Study Details

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.

Key Dates

First listed
May 18, 2022
Start date
Aug 1, 2022
Status verified
May 2022
Primary completion
Oct 1, 2023
Completion
Jul 1, 2024

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TRS003.
    Lead in Treatment Period * Will consist of 6 cycles of Bevacizumab® + mFOLFOX6 * Each cycle length is 14 days After completion of the Lead-in Period, patients who have not progressed or experienced intolerable side effects and remain on study will be randomized 1:1 to either the Non-Switch or Switch Arm of the study. Switch Arm * 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 (to occur during Cycle 14, adequate for washout of preceding Bevacizumab®).
  • Active Comparator: China-approved Bevacizumab
    Lead in Treatment Period * Will consist of 6 cycles of Bevacizumab® + mFOLFOX6 * Each cycle length is 14 days After completion of the Lead-in Period, patients who have not progressed or experienced intolerable side effects and remain on study will be randomized 1:1 to either the Non-Switch or Switch Arm of the study. Non-Switch Arm: * Bevacizumab®, 5 mg/kg administered IV every 14 days * mFOLFOX6 administered as described above every 14 days

Primary Outcome Measure

AUCtau，Area under the curve over the dosing interval [ Time Frame: Cycle 14 (each cycle is 14 days) ]

Central Contacts

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