Metastatic Colorectal CancerPhase 1NCT07543744
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
A Phase 1 study testing RPH-030, Vectibix® and Irinotecan in people with Metastatic Colorectal Cancer, run by R-Pharm at 26 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- RPH-030, Vectibix® and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 26 sitesRussia
- Study dates
- 17 Apr 2025to Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
- Any other medical condition or comorbidity that, in the investigator's opinion, significantly increases the risk of adverse events during the study
- Gilbert's syndrome at randomization or in medical history
- Hematologic abnormalities:
- Absolute neutrophil count (ANC) <1.5 × 10^9/L
- Platelet count <100 × 10^9/L
- Hemoglobin <90 g/L
- Renal impairment:
- Serum creatinine >1.5 × ULN or Glomerular Filtration Rate (GFR) <45 mL/min (calculated via CKD-EPI formula)
- Hepatic impairment:
- Total bilirubin ≥ 1.5 × ULN
- AST or ALT ≥ 3.0 ULN (≥ 5 × ULN for patients with liver metastases)
- Alkaline phosphatase (ALP) ≥ 5 × ULN
- Feasibility of radical resection of all metastatic lesions
- History of other malignancies that are progressive or required treatment within 5 years prior to signing the ICF, excluding radically treated cervical carcinoma in situ, breast cancer in situ, or basal/squamous cell skin carcinoma
- Conditions limiting the patient's ability to comply with protocol requirements (e.g., dementia, neurological or psychiatric disorders, drug addiction (excluding the use of narcotic analgesics for pain management), alcohol dependence, etc.). Religious or personal beliefs that may potentially limit standard therapies within the study (e.g., refusal of blood transfusions) are considered conditions limiting protocol compliance
- Concurrent participation in other interventional clinical trials, participation in other clinical trials within 30 days prior to signing the ICF (provided the patient received at least one dose of investigational therapy), or prior participation in this clinical trial (provided the patient received at least one dose of panitumumab)
- Acute infectious diseases or exacerbation of chronic infections within 28 days prior to the planned date of randomization
- Major surgery within 28 days prior to the planned date of randomization. Major surgery is defined as procedures involving entry into a major body cavity (abdomen, chest, or skull) performed under general anesthesia. Placement of a venous port system for antitumor therapy or an intestinal stoma is not considered major surgery
- Positive test result for any of the following: hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (anti-HCV), antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV-1 and anti-HIV-2), or a blood test for syphilis at screening or within 3 months prior to the planned date of randomization
- Inability to receive intravenous (IV) administration of the investigational product
- Contraindication to any type of intravenous contrast enhancement (non-contrast chest CT is permitted if medically indicated)
- Current continuous daily treatment with corticosteroids at doses >10 mg/day (prednisolone equivalent) or >1.5 mg/day (dexamethasone equivalent), excluding topical steroids
- Hypersensitivity to any components of the study drugs specified in the protocol or intolerance to any premedication drugs
- History of hypersensitivity to monoclonal antibody (mAb) therapies
- Pregnancy or breastfeeding
- Consumption of more than 10 units of alcohol per week or a history of alcoholism or drug addiction. One unit of alcohol is defined as 250 mL of beer, 125 mL of wine, or 30 mL of spirits
- Presence of any other significant comorbidities or conditions that, in the reasonable opinion of the Investigator, may adversely affect the patient's participation and well-being in the study and/or confound the evaluation of study results
- Inability to perform venous blood sampling or to insert a venous catheter required for biosample collection (applicable to patients enrolled in the pharmacokinetic study)
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
Russia26 sites, 26 recruiting
- Recruiting
State Budgetary Healthcare Institution of the Arkhangelsk Region "Arkhangelsk Oncology Dispensary"
Arkhangelsk, 163045
Yana Chapko, +79062821765, yanachapko@gmail.com
- Recruiting
Moscow City Oncology Hospital No. 62 (MGOB 62)
Istra, 143515
Daniil Stroyakovskiy, +79166122028, stroyakovskiy@mail.ru
- Recruiting
Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"
Ivanovo, 153051
Yana Pavlova, +79158484942, uvik007@mail.ru
- Recruiting
State Budgetary Healthcare Institution of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"
Kaluga, 248007
Irina Rozhkova, +7 906 642 37 77, rozkova-i-a@yandex.ru
- 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
Rustem Safin, +79172729793, rustem1408@mail.ru
- Recruiting
State Budgetary Healthcare Institution "Kuzbass Clinical Oncology Dispensary named after M.S. Rappoport" (SBHI "KCOD")
Kemerovo, 650036
Alexander Sobolev, +79134643995, doktoralex@mail.ru
- Recruiting
State Budgetary Healthcare Organisation "Clinical Oncology Dispensary No. 1" under the Ministry of Healthcare of Krasnodar region
Krasnodar, 350040
Julia Makarova, +79184177410, best.makarova@gmail.com
- Recruiting
Regional Budgetary Healthcare Institution "Kursk Oncology Research and Clinical Center named after G.E. Ostroverkhov"
Kursk, 305524
Egor Grebenkin, +79852950188, engrebenkin46@gmail.com
- Recruiting
State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"
Kuz'molovskiy, 191104
Igor Belogortsev, +7-911-218-59-27, io.belogortsev@lokod.ru
- Recruiting
The Loginov Moscow Clinical Scientific Center (MCSC)
Moscow, 111123
Lyudmila Zhukova, +79267694848, zhukova.lyudmila008@mail.ru
- Recruiting
N.N. Blokhin National Medical Research Center of Oncology (Blokhin NRC of Oncology)
Moscow, 115522
Alexey Tryakin, +79037380774, atryakin@gmail.com
- Recruiting
Oncology Center No. 1 of the City Clinical Hospital named after S.S. Yudin of the Moscow Healthcare Department
Moscow, 117152
Ilya Pokataev, +79262858986, pokia@mail.ru
- Recruiting
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, 119435
Marina Sekacheva, +79165134577, Sekach_rab@mail.ru
- Recruiting
Branch of the Limited Liability Company "Hadassah Medical Ltd." (LLC Branch "Hadassah Medical")
Moscow, 121205
Igor Utyashev, +7 926 589 42 52, dr.Utyashev@gmail.com
- Recruiting
Federal State Autonomous Institution "National Medical Research Center 'Medical and Rehabilitation Center'" of the Ministry of Health of the Russian Federation
Moscow, 125367
Pavel Sakulin, +7 968 056 47 60, Sakulin.pavel@mail.ru
- Recruiting
Research Lab LLC
Moscow, 127521
Marina Lyadova, +79104371016, dr.lyadova@gmail.com
- Recruiting
Joint-Stock Company "Medsi Group of Companies"
Moscow, 143442
Anastasia Mochalova, +79264179316, Denisovaas@mail.ru
- Recruiting
Limited Liability Company Medical and Sanitary Unit "Clinician-Pretor Clinic"
Novosibirsk, 630091
Vadim Kozlov, +7 913 463 82 86, vadimkozlov80@mail.ru
- Recruiting
Federal State Budgetary Healthcare Institution "Clinical Hospital No. 8 of the Federal Medical-Biological Agency of Russia"
Obninsk, 249032
Guzel Zinnatullina, +79177823905, zinnatullina-gf@mail.ru
- 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
Alexander Fedenko, +79262110975, medonc@yandex.ru
- Recruiting
Omsk Region Budgetary Healthcare Institution "Clinical Oncology Dispensary"
Omsk, 644013
Irina Radyukova, +79139647001, rim74@yandex.ru
- Recruiting
Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of Saint-Petersburg"
Saint Petersburg, 195271
Konstantin Penkov, +7 951 676 06 96, penkov76@gmail.com
- Recruiting
City Clinical Oncology Dispensary (Saint Petersburg)
Saint Petersburg, 198255
Rashida Orlova, +79111019156, orlova_rashida@mail.ru
- Recruiting
State Health Institution "Tula Regional Clinical Oncology Dispensary"
Tula, 300039
Liana Mukova, +79287013033, lianaonko@yandex.ru
- Recruiting
State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary"
Volgograd, 400138
Nadezhda Kovalenko, +79696510003, nkovalenkost@mail.ru
- Recruiting
State Institution of Healthcare of Yaroslavl Region "Regional Oncology Hospital"
Yaroslavl, 150054
Sergey Belonogov, +79301188888, sergey.belonogov@mail.ru
About this study
Official title: Multicenter, Double-blind, Randomized, Comparative Study of the Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With With Metastatic Colorectal Cancer (mCRC) With Wild-type RAS as First-line Therapy in Combination With FOLFIRI
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.
Read the detailed description
This study is a multicenter, double-blind, randomized, comparative, phase I study
Treatment with panitumumab in combination with FOLFIRI (de Gramont) within of this study will continue for up to 2 years or disease progression/unacceptable toxicity/patient refusal to continue therapy (in whichever comes first)
The study will include the following periods:
- Screening period: days -27 to 0 (up to 1 administration of the study therapy) If a tumor biopsy is required for histological diagnosis verification and testing of KRAS/NRAS, BRAF mutation status, Her2/neu status, and MSI status, the screening period may be extended up to 42 days
- Main period: days 1 to 182 Eligible patients will be randomized at the ratio of 1:1 to one of the two study arms: RPH-030 and Vectibix®. During the Main Period of the study, patients will receive panitumumab (RPH-030 or Vectibix®) at a dose of 6 mg/kg intravenously (IV) once every 2 weeks (2 weeks = 1 cycle) in combination with FOLFIRI (after 8 cycles, patients will be switched to the de Gramont regimen) Therapy during the Main Study Period will continue until the earliest of the following:
- Completion of 6 months (up to 13 cycles inclusive)
- Disease progression (according to RECIST 1.1 criteria or clinical progression)
- Development of unacceptable toxicity
- Patient's withdrawal of consent to continue treatment Tumor response assessment during the Main Study Period will be performed approximately every 6 weeks Patients will be hospitalized at least twice: at Visit 1 (Day 1) and Visit 3 (Day 29) either before drug administration or on the eve of it; the duration of hospitalization will be at least 24 hours from the start of panitumumab infusion
- Period of continued therapy: days 183 to 365 During the period of continued therapy, all patients will receive RPH-030 therapy, including those patients who received Vectibix® therapy during the Main Period Therapy during this period will continue until the earliest of the following:
- Up to 1 year of therapy
- Disease progression (according to RECIST 1.1 criteria or clinical progression)
- Development of unacceptable toxicity
- Patient's withdrawal of consent to continue treatment Assessment of the tumor response to therapy during the period of continued therapy will be performed approximately once every 8 weeks
- Treatment Extension Period: days 366 to 729 Participants in the Treatment Extension Period will be patients who demonstrate stable disease (SD) or tumor response after 1 year of therapy. The decision to enter this period will be made by the investigator Therapy during the Treatment Extension Period will continue until the earliest of the following:
- For a total duration of up to 2 years
- Disease progression (according to RECIST 1.1 criteria or clinical progression)
- Development of unacceptable toxicity
- Patient's withdrawal of consent to continue treatment
- Follow-up period (follow-up/FU)
For patients who complete the Treatment Extension Period (either as scheduled or prematurely), a Follow-up visit will be scheduled 28 ± 3 days after the last dose of panitumumab. Following this visit, the patient's participation in the study will be considered complete
Follow-up (FU) visits will be conducted every 8 weeks (±7 days) until Day 365, death, or withdrawal of consent (whichever occurs first):
- For patients who discontinue study therapy due to disease progression or start a new line of treatment (including surgery), FU will be conducted via telephone contact with the patient or relatives to collect overall survival data
- For patients who discontinue study therapy for reasons other than progression and have not started new treatment, FU will include CT/MRI assessments until disease progression, initiation of new therapy, or Day 365. Once progression occurs or new therapy starts, these patients will switch to telephone survival follow-up
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- RPH-030, Vectibix®, Irinotecan, Calcium Folinate, Fluorouracil
- Keywords
- RPH-030, Metastatic Colorectal Cancer, panitumumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPH-030Drug
Also called panitumumab
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
Also called panitumumab
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
IrinotecanDrug
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 FolinateDrug
Calcium Folinate: solution for intravenous and intramuscular administration, 10 mg/mL
FluorouracilDrug
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Vectibix®; Drug: Irinotecan; Drug: Calcium Folinate; Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Maximum serum concentration of panitumumab after the first administration (Cmax)
Measured: 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)
Maximum serum concentration of panitumumab at steady state (after the third administration) (Cmax ss)
Measured: 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)
Minimum serum concentration of panitumumab at steady state (in three administrations) (Cmin ss)
Measured: 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)
Residual concentration of panitumumab at steady state (before the third administration) (Ctrough)
Measured: 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
Proportion of patients (%) with adverse drug reactions (ADRs) of any severity
Measured: Up to day 729
Proportion of patients (%) with adverse events (AEs) of any severity
Proportion of patients (%) with adverse events (AEs) of any severity
Measured: Up to day 729
Proportion of patients (%) with AEs of severity grade ≥ 3
Proportion of patients (%) with AEs of severity grade ≥ 3 according to CTCAE 5.0
Measured: Up to day 729
Proportion of patients (%) with ADRs of severity grade ≥ 3
Proportion of patients (%) with ADRs of severity grade ≥ 3 according to CTCAE 5.0
Measured: Up to day 729
Proportion of patients (%) with serious adverse events (SAEs)
Proportion of patients (%) with serious adverse events (SAEs)
Measured: Up to day 729
Proportion of patients (%) with serious adverse drug reactions (SADRs)
Proportion of patients (%) with serious adverse drug reactions (SADRs)
Measured: Up to day 729
Proportion of patients (%) who required discontinuation of treatment due to development of ADRs
Proportion of patients (%) who required discontinuation of treatment due to development of ADRs
Measured: Up to day 729
Proportion of patients (%) who developed anti-drug antibodies (ADA) to panitumumab
Proportion of patients (%) who developed anti-drug antibodies (ADA) to panitumumab
Measured: Pre-dose on Day 1 (first administration); 1008 (Day 43), 2688 (Day 113), 4032 (Day 169), 5376 (Day 225), 6720 (Day 281), 8400 (Day 351) h post-dose
Proportion of patients (%) who developed neutralizing antibodies (NAb) to panitumumab
Proportion of patients (%) who developed neutralizing antibodies (NAb) to panitumumab
Measured: Pre-dose on Day 1 (first administration); 1008 (Day 43), 2688 (Day 113), 4032 (Day 169), 5376 (Day 225), 6720 (Day 281), 8400 (Day 351) h post-dose
Proportion of patients (%) developing dermatologic toxicity
Proportion of patients (%) developing dermatologic toxicity
Measured: Up to day 729
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start17 Apr 2025
- Primary completion15 May 2026 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543744
- Sponsor's protocol ID
- CL01790199
- Status last verified
- Feb 2026
- First submitted
- 14 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind, Randomized, Comparative Study of the Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With With Metastatic Colorectal Cancer (mCRC) With Wild-type RAS as First-line Therapy in Combination With FOLFIRI
- ClinicalTrials.gov ID
- NCT07543744
- Acronym / sponsor ID
- CL01790199
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- RPH-030, Metastatic Colorectal Cancer, panitumumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a multicenter, double-blind, randomized, comparative, phase I study
Treatment with panitumumab in combination with FOLFIRI (de Gramont) within of this study will continue for up to 2 years or disease progression/unacceptable toxicity/patient refusal to continue therapy (in whichever comes first)
The study will include the following periods:
- Screening period: days -27 to 0 (up to 1 administration of the study therapy) If a tumor biopsy is required for histological diagnosis verification and testing of KRAS/NRAS, BRAF mutation status, Her2/neu status, and MSI status, the screening period may be extended up to 42 days
- Main period: days 1 to 182 Eligible patients will be randomized at the ratio of 1:1 to one of the two study arms: RPH-030 and Vectibix®. During the Main Period of the study, patients will receive panitumumab (RPH-030 or Vectibix®) at a dose of 6 mg/kg intravenously (IV) once every 2 weeks (2 weeks = 1 cycle) in combination with FOLFIRI (after 8 cycles, patients will be switched to the de Gramont regimen) Therapy during the Main Study Period will continue until the earliest of the following:
- Completion of 6 months (up to 13 cycles inclusive)
- Disease progression (according to RECIST 1.1 criteria or clinical progression)
- Development of unacceptable toxicity
- Patient's withdrawal of consent to continue treatment Tumor response assessment during the Main Study Period will be performed approximately every 6 weeks Patients will be hospitalized at least twice: at Visit 1 (Day 1) and Visit 3 (Day 29) either before drug administration or on the eve of it; the duration of hospitalization will be at least 24 hours from the start of panitumumab infusion
- Period of continued therapy: days 183 to 365 During the period of continued therapy, all patients will receive RPH-030 therapy, including those patients who received Vectibix® therapy during the Main Period Therapy during this period will continue until the earliest of the following:
- Up to 1 year of therapy
- Disease progression (according to RECIST 1.1 criteria or clinical progression)
- Development of unacceptable toxicity
- Patient's withdrawal of consent to continue treatment Assessment of the tumor response to therapy during the period of continued therapy will be performed approximately once every 8 weeks
- Treatment Extension Period: days 366 to 729 Participants in the Treatment Extension Period will be patients who demonstrate stable disease (SD) or tumor response after 1 year of therapy. The decision to enter this period will be made by the investigator Therapy during the Treatment Extension Period will continue until the earliest of the following:
- For a total duration of up to 2 years
- Disease progression (according to RECIST 1.1 criteria or clinical progression)
- Development of unacceptable toxicity
- Patient's withdrawal of consent to continue treatment
- Follow-up period (follow-up/FU)
For patients who complete the Treatment Extension Period (either as scheduled or prematurely), a Follow-up visit will be scheduled 28 ± 3 days after the last dose of panitumumab. Following this visit, the patient's participation in the study will be considered complete
Follow-up (FU) visits will be conducted every 8 weeks (±7 days) until Day 365, death, or withdrawal of consent (whichever occurs first):
- For patients who discontinue study therapy due to disease progression or start a new line of treatment (including surgery), FU will be conducted via telephone contact with the patient or relatives to collect overall survival data
- For patients who discontinue study therapy for reasons other than progression and have not started new treatment, FU will include CT/MRI assessments until disease progression, initiation of new therapy, or Day 365. Once progression occurs or new therapy starts, these patients will switch to telephone survival follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| RPH-030 + Irinotecan + Calcium Folinate + Fluorouracil | Experimental | Drug: RPH-030, Drug: Irinotecan, Drug: Calcium Folinate, Drug: FluorouracilPanitumumab 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 |
| Vectibix® + Irinotecan + Calcium Folinate + Fluorouracil | Active comparator | Drug: Vectibix®, Drug: Irinotecan, Drug: Calcium Folinate, Drug: FluorouracilPanitumumab 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (43 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPH-030Also: panitumumabRPH-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 | Drug | RPH-030 + Irinotecan + Calcium Folinate + Fluorouracil |
| Vectibix®Also: panitumumabVectibix®: 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 | Drug | Vectibix® + Irinotecan + Calcium Folinate + Fluorouracil |
| IrinotecanIrinotecan: 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 | Drug | RPH-030 + Irinotecan + Calcium Folinate + Fluorouracil, Vectibix® + Irinotecan + Calcium Folinate + Fluorouracil |
| Calcium FolinateCalcium Folinate: solution for intravenous and intramuscular administration, 10 mg/mL | Drug | RPH-030 + Irinotecan + Calcium Folinate + Fluorouracil, Vectibix® + Irinotecan + Calcium Folinate + Fluorouracil |
| FluorouracilFluorouracil: 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 | Drug | RPH-030 + Irinotecan + Calcium Folinate + Fluorouracil, Vectibix® + Irinotecan + Calcium Folinate + Fluorouracil |
Primary outcome
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
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
Area under the pharmacokinetic curve "concentration-time" of panitumumab at steady state (AUC tau ss)
Time frame: 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
Area under the pharmacokinetic curve "concentration-time" of panitumumab at steady state (after the third administration) (AUC tau ss)
14 secondary outcomes
Maximum serum concentration of panitumumab after the first administration (Cmax)
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
Maximum serum concentration of panitumumab at steady state (Cmax ss)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Up to day 729
Proportion of patients (%) with adverse events (AEs) of any severity
Time frame: Up to day 729
Proportion of patients (%) with AEs of severity grade ≥ 3
Time frame: Up to day 729
Proportion of patients (%) with ADRs of severity grade ≥ 3
Time frame: Up to day 729
Proportion of patients (%) with serious adverse events (SAEs)
Time frame: Up to day 729
Proportion of patients (%) with serious adverse drug reactions (SADRs)
Time frame: Up to day 729
Proportion of patients (%) who required discontinuation of treatment due to development of ADRs
Time frame: Up to day 729
Proportion of patients (%) who developed anti-drug antibodies (ADA) to panitumumab
Time frame: Pre-dose on Day 1 (first administration); 1008 (Day 43), 2688 (Day 113), 4032 (Day 169), 5376 (Day 225), 6720 (Day 281), 8400 (Day 351) h post-dose
Proportion of patients (%) who developed neutralizing antibodies (NAb) to panitumumab
Time frame: Pre-dose on Day 1 (first administration); 1008 (Day 43), 2688 (Day 113), 4032 (Day 169), 5376 (Day 225), 6720 (Day 281), 8400 (Day 351) h post-dose
Proportion of patients (%) developing dermatologic toxicity
Time frame: Up to day 729
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mikhail Samsonov study director
R-Pharm
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RPH-030, Vectibix® and Irinotecan in people with Metastatic Colorectal Cancer, run by R-Pharm at 26 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrey Osherov (+79690189217, osherov@rpharm.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.