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Tests treatment safety and results for Metastatic Colorectal Cancer
Official 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
ClinicalTrials.gov ID: NCT07543744
What this study is testing
What is RPH-030?
RPH-030 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer.
Also referred to as panitumumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- RAS wild-type (WT) status
You likely can't join 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...
- 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...
- Presence of BRAF gene mutation (if BRAF testing results are unavailable, testing will be performed at a central laboratory; results must be obtained...
- Severe comorbidities or life-threatening acute complications of the underlying disease (including massive pleural, pericardial, or peritoneal...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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)...
- Concurrent participation in other treatment 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)...
- 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...
- 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...
- 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...
- Inability to perform venous blood sampling or to insert a venous catheter required for biosample collection (applicable to patients enrolled in the pharmacokinetic study)
The study team makes the final eligibility decision.
Where it's taking place
- Arkhangelsk, Russia
- Istra, Russia
- Ivanovo, Russia
- Kaluga, Russia
- Kazan', Russia
- Kemerovo, Russia
- Krasnodar, Russia
- Kursk, Russia
- Kuz'molovskiy, Russia
- Moscow, Russia
- Novosibirsk, Russia
- Obninsk, Russia
- Omsk, Russia
- Saint Petersburg, Russia
- Tula, Russia
- Volgograd, Russia
- Yaroslavl, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arkhangelsk, Russia; Istra, Russia; Ivanovo, Russia; Kaluga, Russia; Kazan', Russia; Kemerovo, Russia and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.