Actively Recruiting
Multicenter, Double-blind, Randomized, Comparative Study of the Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix4 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
115 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics, safety, and immune response of two drugs, RPH-030 and Vectibix4, in patients with metastatic colorectal cancer (mCRC) who have wild-type RAS genes. The study aims to show that these treatments are equivalent in how the body processes them and to compare their safety and immune effects. Additionally, the study will explore how effective these drugs are when used as first-line therapy combined with FOLFIRI chemotherapy. Participants will receive either RPH-030 or Vectibix4 intravenously at 6 mg/kg every two weeks along with FOLFIRI chemotherapy, which includes irinotecan, calcium folinate, and fluorouracil. Treatment starts with FOLFIRI for 8 cycles, then continues with a modified de Gramont regimen. The study includes several periods: a screening phase, a main period lasting up to 6 months, a continued therapy period up to 1 year where all patients receive RPH-030, and a treatment extension period lasting up to 2 years for patients with stable disease or response. Follow-up visits occur after treatment ends to monitor survival and disease status. Participants will undergo regular tumor assessments approximately every 6 to 8 weeks, hospitalizations for drug administration at specific visits, and blood sampling for pharmacokinetic and safety evaluations. Researchers will monitor drug levels over time, adverse events, immune reactions, and tumor responses. Follow-up includes imaging or phone calls to track overall survival and disease progression. The total study participation can last up to about 2 years with additional follow-up to ensure thorough monitoring of outcomes and safety.
CONDITIONS
Brief 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
- Histologically confirmed metastatic colorectal adenocarcinoma
- Consent to biopsy if needed for diagnosis
- Candidates for first-line therapy with metastatic colorectal cancer
- Wild-type RAS gene status
- ECOG performance status 0-1
- At least one measurable tumor lesion (excluding single bone lesions)
- Recovery from prior therapy side effects to Grade 1 or less, except certain chronic conditions
- 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 contraception or abstain from intercourse during and after treatment if of childbearing potential
- Ability to follow study procedures
- For pharmacokinetic study participants, body weight between 50 and 100 kg at consent
You will not qualify if you...
- Prior systemic anti-cancer therapy except certain chemotherapy
- Prior anti-EGFR antibody or EGFR tyrosine kinase inhibitor therapy
- Concurrent immunotherapy, hormonal therapy, or unspecified cancer treatments
- Major surgery within 28 days or recent radiotherapy with residual toxicity
- Presence of BRAF mutation
- Severe comorbidities or life-threatening complications
- Paralytic ileus, gastrointestinal obstruction, or uncontrolled diarrhea
- Progressive or symptomatic brain metastases requiring steroids or anticonvulsants
- Unstable or severe cardiovascular and respiratory diseases
- Uncontrolled hypertension
- Gilbert's syndrome
- Blood count abnormalities below specified levels
- Significant kidney or liver impairment
- Feasibility of radical surgery for metastases
- Recent other malignancies requiring treatment
- Conditions limiting compliance, including certain psychiatric or addiction disorders
- Participation in other clinical trials within 30 days
- Recent acute or chronic infections
- Contraindications to intravenous drug administration or contrast
- High-dose daily corticosteroid use
- Hypersensitivity to study drugs or monoclonal antibodies
- Pregnancy or breastfeeding
- Excessive alcohol use or history of addiction
- Other significant health conditions affecting participation
- Inability to perform required blood sampling for pharmacokinetic study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 6 months
Participants receive panitumumab (RPH-030 or Vectibix®) combined with FOLFIRI chemotherapy every 2 weeks. After 8 cycles, chemotherapy changes to the modified de Gramont regimen. Treatment continues for up to 6 months or until disease progression, unacceptable toxicity, or withdrawal.
Biweekly visits with at least 2 hospitalizations of at least 24 hours each during treatment
Duration - Up to 6 months
Participants continue receiving RPH-030 therapy for up to 1 year or until disease progression, unacceptable toxicity, or withdrawal. Tumor response is assessed approximately every 8 weeks.
Visits approximately every 8 weeks
Duration - Up to 1 year
Participants with stable disease or tumor response after 1 year may continue therapy up to a total of 2 years, or until disease progression, unacceptable toxicity, or withdrawal.
Visits approximately every 8 weeks
Duration - Up to 1 year
Participants who complete or discontinue treatment enter follow-up with visits every 8 weeks until 1 year after treatment ends, death, or withdrawal. Follow-up includes imaging assessments or telephone contacts to monitor survival and disease status.
Visits or telephone contacts every 8 weeks
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
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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