A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in P… (NCT07543744) | Clinical Trial Compass
RecruitingPhase 1
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
Russia180 participantsStarted 2025-04-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
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
. 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)
Exclusion criteria
. 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)
. 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