> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-comparative-study-of-pharmacokinetics-safety-and-77df5d2a-bf8d-405f-aa8e-43f39eb748f0 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) Participants 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) Lead sponsor R-Pharm Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) Start date 2025-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) Number of sites 26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Short 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) ## Dates **Completion date** 2028-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **First posted** 2026-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Registry last updated** 2026-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Primary completion date** 2026-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Start date** 2025-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) ## Size and sites **Participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Planned participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Number of sites** 26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Lead sponsor** R-Pharm Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) ## Identifiers **Registry ID** NCT07543744 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **ClinicalTrials.gov ID** NCT07543744 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) ## Outcomes ### Primary outcomes 1. Area under the pharmacokinetic curve "concentration-time" (AUC(0-336)) of panitumumab Timeframe: 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 2. Area under the pharmacokinetic curve "concentration-time" of panitumumab at steady state (AUC tau ss) Timeframe: 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) ### Secondary outcomes 1. Maximum serum concentration of panitumumab after the first administration (Cmax) Timeframe: 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 after the first administration (Cmax) 2. Maximum serum concentration of panitumumab at steady state (Cmax ss) Timeframe: 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 Maximum serum concentration of panitumumab at steady state (after the third administration) (Cmax ss) 3. Minimum serum concentration of panitumumab at steady state (Cmin ss) Timeframe: 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 (in three administrations) (Cmin ss) 4. Residual concentration of panitumumab at steady state (Ctrough) Timeframe: 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 (before the third administration) (Ctrough) 5. Proportion of patients (%) with adverse drug reactions (ADRs) of any severity Timeframe: Up to day 729 Proportion of patients (%) with adverse drug reactions (ADRs) of any severity 6. Proportion of patients (%) with adverse events (AEs) of any severity Timeframe: Up to day 729 Proportion of patients (%) with adverse events (AEs) of any severity 7. Proportion of patients (%) with AEs of severity grade ≥ 3 Timeframe: Up to day 729 Proportion of patients (%) with AEs of severity grade ≥ 3 according to CTCAE 5.0 8. Proportion of patients (%) with ADRs of severity grade ≥ 3 Timeframe: Up to day 729 Proportion of patients (%) with ADRs of severity grade ≥ 3 according to CTCAE 5.0 9. Proportion of patients (%) with serious adverse events (SAEs) Timeframe: Up to day 729 Proportion of patients (%) with serious adverse events (SAEs) 10. Proportion of patients (%) with serious adverse drug reactions (SADRs) Timeframe: Up to day 729 Proportion of patients (%) with serious adverse drug reactions (SADRs) 11. Proportion of patients (%) who required discontinuation of treatment due to development of ADRs Timeframe: Up to day 729 Proportion of patients (%) who required discontinuation of treatment due to development of ADRs 12. Proportion of patients (%) who developed anti-drug antibodies (ADA) to panitumumab Timeframe: 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 anti-drug antibodies (ADA) to panitumumab 13. Proportion of patients (%) who developed neutralizing antibodies (NAb) to panitumumab Timeframe: 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 14. Proportion of patients (%) developing dermatologic toxicity Timeframe: Up to day 729 Proportion of patients (%) developing dermatologic toxicity Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. A voluntarily signed and dated Informed Consent form (ICF) of the patient 2. 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) 3. Patient consent to undergo a screening biopsy if archival tissue samples are unavailable for histological diagnosis verification 4. Patients with metastatic colorectal cancer (mCRC), either de novo metastatic or recurrent with distant metastases, who are candidates for first-line therapy 5. RAS wild-type (WT) status 6. ECOG status 0-1 7. Presence of at least one measurable lesion according to RECIST 1.1 criteria (patients with a single measurable bone lesion are not eligible) 8. 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) 9. Serum magnesium ≥ 0.66 mmol/L, total calcium ≥ 2.15 mmol/L, and potassium ≥ 3.5 mmol/L at the time of randomization 10. Life expectancy of ≥ 13 weeks from the time of randomization (as per the investigator's assessment) 11. 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) 12. Ability to comply with protocol procedures in the opinion of the investigator 13. For patients participating in the pharmacokinetic study, body weight must be within 50-100 kg at the time of informed consent signing ### Exclusion criteria 1. Prior systemic antitumor therapy (except for neoadjuvant or adjuvant fluoropyrimidine-based chemotherapy) 2. Prior therapy with anti-EGFR monoclonal antibodies (e.g., cetuximab, panitumumab) or small molecule EGFR tyrosine kinase inhibitors (e.g., gefitinib, erlotinib, afatinib) 3. Concomitant systemic immunotherapy or hormonal cancer therapy, or concurrent use of other cancer treatments not specified in the Protocol 4. 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 5. 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) 6. Severe comorbidities or life-threatening acute complications of the underlying disease (including massive pleural, pericardial, or peritoneal effusion requiring intervention) 7. Paralytic ileus, gastrointestinal obstruction, or uncontrolled diarrhea (disabling symptoms despite adequate treatment) 8. 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 9. 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 10. Gilbert's syndrome at randomization or in medical history 11. Hematologic abnormalities: - Absolute neutrophil count (ANC) <1.5 × 10^9/L - Platelet count <100 × 10^9/L - Hemoglobin <90 g/L 12. Renal impairment: \- Serum creatinine >1.5 × ULN or Glomerular Filtration Rate (GFR) <45 mL/min (calculated via CKD-EPI formula) 13. 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 14. Feasibility of radical resection of all metastatic lesions 15. 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 16. 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 17. 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) 18. Acute infectious diseases or exacerbation of chronic infections within 28 days prior to the planned date of randomization 19. 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 20. 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 21. Inability to receive intravenous (IV) administration of the investigational product 22. Contraindication to any type of intravenous contrast enhancement (non-contrast chest CT is permitted if medically indicated) 23. Current continuous daily treatment with corticosteroids at doses >10 mg/day (prednisolone equivalent) or >1.5 mg/day (dexamethasone equivalent), excluding topical steroids 24. Hypersensitivity to any components of the study drugs specified in the protocol or intolerance to any premedication drugs 25. History of hypersensitivity to monoclonal antibody (mAb) therapies 26. Pregnancy or breastfeeding 27. 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 28. 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 29. Inability to perform venous blood sampling or to insert a venous catheter required for biosample collection (applicable to patients enrolled in the pharmacokinetic study) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) ## Sites - State Budgetary Healthcare Institution of the Arkhangelsk Region "Arkhangelsk Oncology Dispensary"Arkhangelsk, RussiaRecruiting - Moscow City Oncology Hospital No. 62 (MGOB 62)Istra, RussiaRecruiting - Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"Ivanovo, RussiaRecruiting - State Budgetary Healthcare Institution of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"Kaluga, RussiaRecruiting - 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', RussiaRecruiting - State Budgetary Healthcare Institution "Kuzbass Clinical Oncology Dispensary named after M.S. Rappoport" (SBHI "KCOD")Kemerovo, RussiaRecruiting - State Budgetary Healthcare Organisation "Clinical Oncology Dispensary No. 1" under the Ministry of Healthcare of Krasnodar regionKrasnodar, RussiaRecruiting - Regional Budgetary Healthcare Institution "Kursk Oncology Research and Clinical Center named after G.E. Ostroverkhov"Kursk, RussiaRecruiting - State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"Kuz'molovskiy, RussiaRecruiting - The Loginov Moscow Clinical Scientific Center (MCSC)Moscow, RussiaRecruiting - N.N. Blokhin National Medical Research Center of Oncology (Blokhin NRC of Oncology)Moscow, RussiaRecruiting - Oncology Center No. 1 of the City Clinical Hospital named after S.S. Yudin of the Moscow Healthcare DepartmentMoscow, RussiaRecruiting - I.M. Sechenov First Moscow State Medical University (Sechenov University)Moscow, RussiaRecruiting - Branch of the Limited Liability Company "Hadassah Medical Ltd." (LLC Branch "Hadassah Medical")Moscow, RussiaRecruiting - Federal State Autonomous Institution "National Medical Research Center 'Medical and Rehabilitation Center'" of the Ministry of Health of the Russian FederationMoscow, RussiaRecruiting - Research Lab LLCMoscow, RussiaRecruiting - Joint-Stock Company "Medsi Group of Companies"Moscow, RussiaRecruiting - Limited Liability Company Medical and Sanitary Unit "Clinician-Pretor Clinic"Novosibirsk, RussiaRecruiting - Federal State Budgetary Healthcare Institution "Clinical Hospital No. 8 of the Federal Medical-Biological Agency of Russia"Obninsk, RussiaRecruiting - 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 InstituteObninsk, RussiaRecruiting - Omsk Region Budgetary Healthcare Institution "Clinical Oncology Dispensary"Omsk, RussiaRecruiting - Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of Saint-Petersburg"Saint Petersburg, RussiaRecruiting - City Clinical Oncology Dispensary (Saint Petersburg)Saint Petersburg, RussiaRecruiting - State Health Institution "Tula Regional Clinical Oncology Dispensary"Tula, RussiaRecruiting - State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary"Volgograd, RussiaRecruiting And 1 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07543744) ## Related records ### Drugs (4) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Irinotecan hydrochloride](https://trialight.com/data/asset/irinotecan-hydrochloride-c1f6b7df-7c76-40f1-92fe-12d71b1f3b25.md) - [Levoleucovorin calcium](https://trialight.com/data/asset/levoleucovorin-calcium-21e918a4-89ff-4c55-aafc-3b4fd0086bc6.md) - [Panitumumab](https://trialight.com/data/asset/panitumumab-ea8dc0f1-ea1f-4586-b6ad-68fc23ba56f1.md) ### Lead sponsors (1) - [R-Pharm](https://trialight.com/data/company/r-pharm-35daefeb-fe56-4d4b-8706-6704c4361de8.md) ### Conditions (2) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Primary condition - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) ### Targets (3) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [TOP1](https://trialight.com/data/target/top1-efb273d0-ed4a-5281-9372-90a0abb25f90.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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