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

Recruiting now · Phase 1

Conditions studied: Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT07543744

Run by

R-Pharm

People needed

180

Starts

2025-04-17

Expected to finish

2028-08-01

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• State Budgetary Healthcare Institution of the Arkhangelsk Region "Arkhangelsk Oncology Dispensary" — Arkhangelsk, Russia (enrolling)
• Moscow City Oncology Hospital No. 62 (MGOB 62) — Istra, Russia (enrolling)
• Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary" — Ivanovo, Russia (enrolling)
• State Budgetary Healthcare Institution of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary" — Kaluga, Russia (enrolling)
• 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 (enrolling)
• State Budgetary Healthcare Institution "Kuzbass Clinical Oncology Dispensary named after M.S. Rappoport" (SBHI "KCOD") — Kemerovo, Russia (enrolling)
• State Budgetary Healthcare Organisation "Clinical Oncology Dispensary No. 1" under the Ministry of Healthcare of Krasnodar region — Krasnodar, Russia (enrolling)
• Regional Budgetary Healthcare Institution "Kursk Oncology Research and Clinical Center named after G.E. Ostroverkhov" — Kursk, Russia (enrolling)
• State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital" — Kuz'molovskiy, Russia (enrolling)
• The Loginov Moscow Clinical Scientific Center (MCSC) — Moscow, Russia (enrolling)
• N.N. Blokhin National Medical Research Center of Oncology (Blokhin NRC of Oncology) — Moscow, Russia (enrolling)
• Oncology Center No. 1 of the City Clinical Hospital named after S.S. Yudin of the Moscow Healthcare Department — Moscow, Russia (enrolling)
• I.M. Sechenov First Moscow State Medical University (Sechenov University) — Moscow, Russia (enrolling)
• Branch of the Limited Liability Company "Hadassah Medical Ltd." (LLC Branch "Hadassah Medical") — Moscow, Russia (enrolling)
• Federal State Autonomous Institution "National Medical Research Center 'Medical and Rehabilitation Center'" of the Ministry of Health of the Russian Federation — Moscow, Russia (enrolling)
• Research Lab LLC — Moscow, Russia (enrolling)
• Joint-Stock Company "Medsi Group of Companies" — Moscow, Russia (enrolling)
• Limited Liability Company Medical and Sanitary Unit "Clinician-Pretor Clinic" — Novosibirsk, Russia (enrolling)
• Federal State Budgetary Healthcare Institution "Clinical Hospital No. 8 of the Federal Medical-Biological Agency of Russia" — Obninsk, Russia (enrolling)
• 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 (enrolling)
• Omsk Region Budgetary Healthcare Institution "Clinical Oncology Dispensary" — Omsk, Russia (enrolling)
• Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of Saint-Petersburg" — Saint Petersburg, Russia (enrolling)
• City Clinical Oncology Dispensary (Saint Petersburg) — Saint Petersburg, Russia (enrolling)
• State Health Institution "Tula Regional Clinical Oncology Dispensary" — Tula, Russia (enrolling)
• State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary" — Volgograd, Russia (enrolling)

Full record on ClinicalTrials.gov

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