A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRI

Sponsor
R-Pharm
Study ID
NCT07543744
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • RPH-030 — DRUG
    RPH-030: concentrate for solution for infusion, 20 mg/mL Panitumumab is diluted in 0.9% sodium chloride for injection under aseptic conditions. The volume required to achieve a dose of 6 mg/kg is withdrawn from the vial and added to a total volume of 100 mL. The final concentration must not exceed 10 mg/mL
  • Vectibix® — DRUG
    Vectibix®: concentrate for solution for infusion, 20 mg/mL Panitumumab is diluted in 0.9% sodium chloride for injection under aseptic conditions. The volume required to achieve a dose of 6 mg/kg is withdrawn from the vial and added to a total volume of 100 mL. The final concentration must not exceed 10 mg/mL
  • Irinotecan — DRUG
    Irinotecan: concentrate for solution for infusion, 20 mg/mL The required amount of Irinotecan should be diluted in either 5% dextrose solution or 0.9% sodium chloride solution for injection
  • Calcium Folinate — DRUG
    Calcium Folinate: solution for intravenous and intramuscular administration, 10 mg/mL
  • Fluorouracil — DRUG
    Fluorouracil: solution for intravascular administration, 50 mg/mL The required amount of Fluorouracil should be diluted in either 5% dextrose solution or 0.9% sodium chloride solution for injection

Study Details

The primary objective of this study is to demonstrate equivalence of pharmacokinetic properties, and comparability of safety and immunogenicity parameters of RPH-030 and Vectibix® following a single (first) intravenous administration to patients with mCRC with wild-type RAS genes as 1-line therapy in combination with FOLFIRI. The additional objective is to perform a pilot evaluation of the efficacy of RPH-030 and Vectibix® following a single (first) intravenous administration to patients with mCRC with wild-type RAS genes as 1-line therapy in combination with FOLFIRI.

Key Dates

Start date
Apr 17, 2025
Status verified
Feb 2026
Primary completion
May 15, 2026
Completion
Aug 31, 2028

Study Design

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

Arms

  • Experimental: RPH-030 + Irinotecan + Calcium Folinate + Fluorouracil
    Panitumumab 6 mg/kg IV every 2 weeks (Q2W). Infusion duration: 60±5 minutes for Cycles 1-3 (PK assessment) and 30-60 minutes thereafter. Combined with FOLFIRI: Irinotecan 180 mg/m² (90±5 min infusion), Calcium Folinate 400 mg/m² (2-hour infusion), followed by 5-Fluorouracil (5-FU) 400 mg/m² bolus and a 46-hour continuous infusion of 5-FU 2400 mg/m² (1200 mg/m²/day). After 8 cycles of chemotherapy according to the FOLFIRI regimen, the patient is transferred to chemotherapy in the modified de Gramont regimen (irinotecan withdrawal) Premedication (e.g., prednisolone, antiemetic) is mandatory before the administration of chemotherapy drugs; no premedication is required before the administration of panitumumab
  • Active Comparator: Vectibix® + Irinotecan + Calcium Folinate + Fluorouracil
    Panitumumab 6 mg/kg IV every 2 weeks (Q2W). Infusion duration: 60±5 minutes for Cycles 1-3 (PK assessment) and 30-60 minutes thereafter. Combined with FOLFIRI: Irinotecan 180 mg/m² (90±5 min infusion), Calcium Folinate 400 mg/m² (2-hour infusion), followed by 5-Fluorouracil (5-FU) 400 mg/m² bolus and a 46-hour continuous infusion of 5-FU 2400 mg/m² (1200 mg/m²/day). After 8 cycles of chemotherapy according to the FOLFIRI regimen, the patient is transferred to chemotherapy in the modified de Gramont regimen (irinotecan withdrawal) Premedication (e.g., prednisolone, antiemetic) is mandatory before the administration of chemotherapy drugs; no premedication is required before the administration of panitumumab

Primary Outcome Measure

Area under the pharmacokinetic curve "concentration-time" (AUC(0-336)) of panitumumab [ Time Frame: Pre-dose on Day 1 (first administration) and 1, 3, 6, 8, 12 h post-dose; 24 (Day 2), 72 (Day 4), 96 (Day 5), 120 (Day 6), 192 (Day 9), 264 (Day 12), 336 (Day 15) h post-dose ]

Central Contacts

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