Actively Recruiting
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
Led by R-Pharm · Updated on 2026-04-22
180
Participants Needed
26
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Histologically confirmed metastatic colorectal adenocarcinoma
- Consent to screening biopsy if archival tissue unavailable
- Candidates for first-line therapy with metastatic colorectal cancer
- Wild-type RAS gene status
- ECOG performance status 0-1
- At least one measurable lesion per RECIST 1.1 (excluding single bone lesions)
- Recovery from prior therapy toxicities to Grade 1 or less (except non-impacting chronic events)
- Serum magnesium ≥ 0.66 mmol/L, calcium ≥ 2.15 mmol/L, potassium ≥ 3.5 mmol/L at randomization
- Life expectancy of at least 13 weeks
- Agreement to use effective contraception or abstinence if of childbearing potential
- Ability to comply with study procedures
- For pharmacokinetic study participants: body weight between 50-100 kg at consent
You will not qualify if you...
- Prior systemic antitumor therapy except neoadjuvant/adjuvant fluoropyrimidine chemotherapy
- Previous anti-EGFR antibody or EGFR tyrosine kinase inhibitor therapy
- Concurrent immunotherapy, hormonal cancer therapy, or unapproved cancer treatments
- Major surgery within 28 days or recent radiotherapy with toxicity within 14 days before randomization
- Presence of BRAF gene mutation
- Severe comorbidities or life-threatening complications
- Paralytic ileus, gastrointestinal obstruction, or uncontrolled diarrhea
- Progressive or symptomatic central nervous system metastases requiring steroids or anticonvulsants
- Serious cardiac conditions or uncontrolled hypertension
- Severe respiratory failure or uncontrolled systemic diseases
- Gilbert's syndrome
- Hematologic abnormalities (neutrophils <1.5 x10^9/L, platelets <100 x10^9/L, hemoglobin <90 g/L)
- Renal impairment (creatinine >1.5x ULN or GFR <45 mL/min)
- Hepatic impairment (elevated bilirubin, AST/ALT, or ALP)
- Feasibility for radical resection of metastases
- History of other recent malignancies requiring treatment
- Conditions limiting protocol compliance such as dementia or substance abuse
- Participation in other clinical trials recently or previously in this trial
- Acute infections within 28 days before randomization
- Positive tests for hepatitis B, C, HIV, or syphilis
- Inability to receive intravenous administration
- Contraindication to intravenous contrast
- Chronic corticosteroid use above specified doses
- Hypersensitivity to study drugs or monoclonal antibody therapies
- Pregnancy or breastfeeding
- Excessive alcohol consumption or history of addiction
- Other significant comorbidities affecting participation or study results
- Inability to perform required blood sampling for pharmacokinetic analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
State Budgetary Healthcare Institution of the Arkhangelsk Region "Arkhangelsk Oncology Dispensary"
Arkhangelsk, Russia, 163045
Actively Recruiting
2
Moscow City Oncology Hospital No. 62 (MGOB 62)
Istra, Russia, 143515
Actively Recruiting
3
Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
Ivanovo, Russia, 153051
Actively Recruiting
4
State Budgetary Healthcare Institution of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"
Kaluga, Russia, 248007
Actively Recruiting
5
State Autonomous Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"
Kazan', Russia, 420029
Actively Recruiting
6
State Budgetary Healthcare Institution "Kuzbass Clinical Oncology Dispensary named after M.S. Rappoport" (SBHI "KCOD")
Kemerovo, Russia, 650036
Actively Recruiting
7
State Budgetary Healthcare Organisation "Clinical Oncology Dispensary No. 1" under the Ministry of Healthcare of Krasnodar region
Krasnodar, Russia, 350040
Actively Recruiting
8
Regional Budgetary Healthcare Institution "Kursk Oncology Research and Clinical Center named after G.E. Ostroverkhov"
Kursk, Russia, 305524
Actively Recruiting
9
State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"
Kuz'molovskiy, Russia, 191104
Actively Recruiting
10
The Loginov Moscow Clinical Scientific Center (MCSC)
Moscow, Russia, 111123
Actively Recruiting
11
N.N. Blokhin National Medical Research Center of Oncology (Blokhin NRC of Oncology)
Moscow, Russia, 115522
Actively Recruiting
12
Oncology Center No. 1 of the City Clinical Hospital named after S.S. Yudin of the Moscow Healthcare Department
Moscow, Russia, 117152
Actively Recruiting
13
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Russia, 119435
Actively Recruiting
14
Branch of the Limited Liability Company "Hadassah Medical Ltd." (LLC Branch "Hadassah Medical")
Moscow, Russia, 121205
Actively Recruiting
15
Federal State Autonomous Institution "National Medical Research Center 'Medical and Rehabilitation Center'" of the Ministry of Health of the Russian Federation
Moscow, Russia, 125367
Actively Recruiting
16
Research Lab LLC
Moscow, Russia, 127521
Actively Recruiting
17
Joint-Stock Company "Medsi Group of Companies"
Moscow, Russia, 143442
Actively Recruiting
18
Limited Liability Company Medical and Sanitary Unit "Clinician-Pretor Clinic"
Novosibirsk, Russia, 630091
Actively Recruiting
19
Federal State Budgetary Healthcare Institution "Clinical Hospital No. 8 of the Federal Medical-Biological Agency of Russia"
Obninsk, Russia, 249032
Actively Recruiting
20
Federal State Budgetary Institution "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation, Branch: P.A. Herzen Moscow Research Oncology Institute
Obninsk, Russia, 249036
Actively Recruiting
21
Omsk Region Budgetary Healthcare Institution "Clinical Oncology Dispensary"
Omsk, Russia, 644013
Actively Recruiting
22
Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of Saint-Petersburg"
Saint Petersburg, Russia, 195271
Actively Recruiting
23
City Clinical Oncology Dispensary (Saint Petersburg)
Saint Petersburg, Russia, 198255
Actively Recruiting
24
State Health Institution "Tula Regional Clinical Oncology Dispensary"
Tula, Russia, 300039
Actively Recruiting
25
State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary"
Volgograd, Russia, 400138
Actively Recruiting
26
State Institution of Healthcare of Yaroslavl Region "Regional Oncology Hospital"
Yaroslavl, Russia, 150054
Actively Recruiting
Research Team
A
Andrey Osherov
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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