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

NCT07543744 | Recruiting Phase 1 DMC

• 1 other identifier: CL01790199
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 26

Brief Summary

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

Metastatic Colorectal Cancer

Keywords

RPH-030; Metastatic Colorectal Cancer; panitumumab

Outcome Measures

Primary Outcomes (2)

• Area under the pharmacokinetic curve "concentration-time" (AUC(0-336)) of panitumumab

  Area under the pharmacokinetic curve "concentration-time" of panitumumab after the first (single dose) administration, truncated at the point before the second administration, i.e. up to 336 hours

  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

• Area under the pharmacokinetic curve "concentration-time" of panitumumab at steady state (AUC tau ss)

  Area under the pharmacokinetic curve "concentration-time" of panitumumab at steady state (after the third administration) (AUC tau ss)

  Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose

Secondary Outcomes (14)

• Maximum serum concentration of panitumumab after the first administration (Cmax)

  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

• Maximum serum concentration of panitumumab at steady state (Cmax ss)

  Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose

• Minimum serum concentration of panitumumab at steady state (Cmin ss)

  Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose

• Residual concentration of panitumumab at steady state (Ctrough)

  Pre-dose on Day 29 (third administration), and 1, 3, 6, 8, 12 h post-dose; 24 (Day 30), 72 (Day 32), 120 (Day 34), 192 (Day 37), 264 (Day 40), 336 (Day 43) h post-dose

• Proportion of patients (%) with adverse drug reactions (ADRs) of any severity

  Up to day 729

Other Outcomes (20)

• Area under the pharmacokinetic curve "concentration-time" (AUC(0-∞)) of panitumumab

  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

• Time to reach the maximum concentration of panitumumab in the blood serum after the first administration (Tmax)

  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

• Elimination half-life of panitumumab after the first administration (T1/2)

  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

Study Arms (2)

RPH-030 + Irinotecan + Calcium Folinate + Fluorouracil

EXPERIMENTAL

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

Drug: RPH-030; Drug: Irinotecan; Drug: Calcium Folinate; Drug: Fluorouracil

Vectibix® + Irinotecan + Calcium Folinate + Fluorouracil

ACTIVE COMPARATOR

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

Drug: Vectibix®; Drug: Irinotecan; Drug: Calcium Folinate; Drug: Fluorouracil

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

Also known as: panitumumab

RPH-030 + Irinotecan + Calcium Folinate + Fluorouracil

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

Also known as: panitumumab

Vectibix® + Irinotecan + Calcium Folinate + Fluorouracil

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

RPH-030 + Irinotecan + Calcium Folinate + Fluorouracil; Vectibix® + Irinotecan + Calcium Folinate + Fluorouracil

Calcium Folinate DRUG

Calcium Folinate: solution for intravenous and intramuscular administration, 10 mg/mL

RPH-030 + Irinotecan + Calcium Folinate + Fluorouracil; Vectibix® + Irinotecan + Calcium Folinate + Fluorouracil

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

RPH-030 + Irinotecan + Calcium Folinate + Fluorouracil; Vectibix® + Irinotecan + Calcium Folinate + Fluorouracil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A voluntarily signed and dated Informed Consent form (ICF) of the patient
• Histologically verified (documented results of respective examinations available) metastatic colorectal adenocarcinoma (in case the results of previous examinations are not available, the diagnosis will be verified in the central laboratory during screening upon receipt and evaluation of the results before randomization)
• Patient consent to undergo a screening biopsy if archival tissue samples are unavailable for histological diagnosis verification
• Patients with metastatic colorectal cancer (mCRC), either de novo metastatic or recurrent with distant metastases, who are candidates for first-line therapy
• RAS wild-type (WT) status
• ECOG status 0-1
• Presence of at least one measurable lesion according to RECIST 1.1 criteria (patients with a single measurable bone lesion are not eligible)
• Absence or resolution of toxic effects from prior therapy (neoadjuvant/adjuvant) or surgical complications to ≤ Grade 1 according to CTCAE v5.0, except for chronic/irreversible adverse events that do not impact the safety profile of the study treatment (e.g., alopecia)
• Serum magnesium ≥ 0.66 mmol/L, total calcium ≥ 2.15 mmol/L, and potassium ≥ 3.5 mmol/L at the time of randomization
• Life expectancy of ≥ 13 weeks from the time of randomization (as per the investigator's assessment)
• Agreement of patients of childbearing potential to remain abstinent from heterosexual intercourse or use highly effective methods of contraception starting from the date of signing the ICF, throughout the treatment period, and for 6 months after the last dose of FOLFIRI and 2 months after the last infusion of panitumumab. Female participants are considered not of childbearing potential if they have experienced permanent cessation of menstruation (self-reported) established retrospectively after 12 months of natural amenorrhea with appropriate clinical status, such as age (range 45-55 years)
• Ability to comply with protocol procedures in the opinion of the investigator
• For patients participating in the pharmacokinetic study, body weight must be within 50-100 kg at the time of informed consent signing

You may not qualify if:

• Prior systemic antitumor therapy (except for neoadjuvant or adjuvant fluoropyrimidine-based chemotherapy)
• Prior therapy with anti-EGFR monoclonal antibodies (e.g., cetuximab, panitumumab) or small molecule EGFR tyrosine kinase inhibitors (e.g., gefitinib, erlotinib, afatinib)
• Concomitant systemic immunotherapy or hormonal cancer therapy, or concurrent use of other cancer treatments not specified in the Protocol
• Major surgery within 28 days, or radiotherapy (except for palliative radiotherapy) with residual signs of radiation toxicity within 14 days prior to the planned date of randomization
• Presence of BRAF gene mutation (if BRAF testing results are unavailable, testing will be performed at a central laboratory; results must be obtained and evaluated prior to randomization)
• Severe comorbidities or life-threatening acute complications of the underlying disease (including massive pleural, pericardial, or peritoneal effusion requiring intervention)
• Paralytic ileus, gastrointestinal obstruction, or uncontrolled diarrhea (disabling symptoms despite adequate treatment)
• Central nervous system (CNS) metastases that are progressive, symptomatic (e.g., cerebral edema, spinal cord compression), or requiring glucocorticosteroids at doses \>10 mg/day (prednisolone equivalent), \>1.5 mg/day (dexamethasone equivalent), or anticonvulsants, whereas patients with treated and stable brain metastases (for ≥4 weeks), asymptomatic non-progressive lesions not requiring steroids/anticonvulsants for ≥4 weeks, or newly diagnosed asymptomatic lesions requiring no therapy may be included
• Ongoing comorbidities at the time of screening that increase the risk of adverse events during study therapy, including:
• Stable angina pectoris (Canadian Cardiovascular Society Grade III-IV), unstable angina, or a history of myocardial infarction within 1 month prior to the planned date of randomization
• Clinically significant cardiac arrhythmias (patients with controlled heart rate/rhythm are eligible)
• Chronic heart failure (New York Heart Association \[NYHA\] Class III-IV)
• Uncontrolled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg despite antihypertensive therapy)
• Severe respiratory failure
• Current severe uncontrolled systemic disease

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (26)

State Budgetary Healthcare Institution of the Arkhangelsk Region "Arkhangelsk Oncology Dispensary"

Arkhangelsk, 163045, Russia

RECRUITING

Moscow City Oncology Hospital No. 62 (MGOB 62)

Istra, 143515, Russia

RECRUITING

Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"

Ivanovo, 153051, Russia

RECRUITING

State Budgetary Healthcare Institution of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"

Kaluga, 248007, Russia

RECRUITING

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', 420029, Russia

RECRUITING

State Budgetary Healthcare Institution "Kuzbass Clinical Oncology Dispensary named after M.S. Rappoport" (SBHI "KCOD")

Kemerovo, 650036, Russia

RECRUITING

State Budgetary Healthcare Organisation "Clinical Oncology Dispensary No. 1" under the Ministry of Healthcare of Krasnodar region

Krasnodar, 350040, Russia

RECRUITING

Regional Budgetary Healthcare Institution "Kursk Oncology Research and Clinical Center named after G.E. Ostroverkhov"

Kursk, 305524, Russia

RECRUITING

State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"

Kuz'molovskiy, 191104, Russia

RECRUITING

The Loginov Moscow Clinical Scientific Center (MCSC)

Moscow, 111123, Russia

RECRUITING

N.N. Blokhin National Medical Research Center of Oncology (Blokhin NRC of Oncology)

Moscow, 115522, Russia

RECRUITING

Oncology Center No. 1 of the City Clinical Hospital named after S.S. Yudin of the Moscow Healthcare Department

Moscow, 117152, Russia

RECRUITING

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, 119435, Russia

RECRUITING

Branch of the Limited Liability Company "Hadassah Medical Ltd." (LLC Branch "Hadassah Medical")

Moscow, 121205, Russia

RECRUITING

Federal State Autonomous Institution "National Medical Research Center 'Medical and Rehabilitation Center'" of the Ministry of Health of the Russian Federation

Moscow, 125367, Russia

RECRUITING

Research Lab LLC

Moscow, 127521, Russia

RECRUITING

Joint-Stock Company "Medsi Group of Companies"

Moscow, 143442, Russia

RECRUITING

Limited Liability Company Medical and Sanitary Unit "Clinician-Pretor Clinic"

Novosibirsk, 630091, Russia

RECRUITING

Federal State Budgetary Healthcare Institution "Clinical Hospital No. 8 of the Federal Medical-Biological Agency of Russia"

Obninsk, 249032, Russia

RECRUITING

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, 249036, Russia

RECRUITING

Omsk Region Budgetary Healthcare Institution "Clinical Oncology Dispensary"

Omsk, 644013, Russia

RECRUITING

Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of Saint-Petersburg"

Saint Petersburg, 195271, Russia

RECRUITING

City Clinical Oncology Dispensary (Saint Petersburg)

Saint Petersburg, 198255, Russia

RECRUITING

State Health Institution "Tula Regional Clinical Oncology Dispensary"

Tula, 300039, Russia

RECRUITING

State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary"

Volgograd, 400138, Russia

RECRUITING

State Institution of Healthcare of Yaroslavl Region "Regional Oncology Hospital"

Yaroslavl, 150054, Russia

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Panitumumab; Irinotecan; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Mikhail Samsonov

  R-Pharm

  STUDY DIRECTOR

Central Study Contacts

Andrey Osherov

CONTACT

+79690189217; osherov@rpharm.ru

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 22, 2026
• Study Start: April 17, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-02

Locations

RU (26)