NCT05378867

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

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Zhejiang Teruisi Pharmaceutical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind Phase 3 clinical trial evaluating the interchangeability, by a comparison of PK parameters between non-Switching and the Switching arms following the final switch between TRS003 and Bevacizumab® in patients with metastatic adenocarcinoma of the colon or rectum (please note that Bevacizumab® means China-approved Bevacizumab® in this protocol, unless otherwise specified). 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. There will be 3 switches as detailed in the Treatment section (below) and the Schema. If oxaliplatin-induced neurotoxicity requires discontinuation of oxaliplatin, treatment will continue using leucovorin (LCV) plus 5-fluorouracil (5-FU) in combination with either Bevacizumab® or TRS003 until progressive disease (PD), intolerability, or other cause for stopping treatment.

Conditions

• Metastatic Colorectal Cancer (CRC)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-10-01
• Completion: 2024-07-01
• First posted: 2022-05-18
• Last updated: 2022-05-18

Regulatory

• FDA-regulated drug study