Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New biosimilar RPH-002 takes on erbitux in head and neck cancer showdown

NCT ID NCT07435324

Disease control Sponsor: R-Pharm Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This phase 3 trial compares a new drug, RPH-002, to the standard treatment Erbitux in 161 patients with advanced head and neck cancer that cannot be removed by surgery. Both drugs are given with chemotherapy. The main goal is to see if RPH-002 works as well as Erbitux in shrinking tumors. The study is active but no longer recruiting participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RPH-002 (a biosimilar to cetuximab)
What this could lead to
If successful, this could offer a more affordable or equally effective alternative to Erbitux for treating advanced head and neck cancer.
What could go wrong
This is a phase 3 trial, but it's still early to know if RPH-002 works as well as Erbitux. Side effects may include infusion reactions and other drug-related risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

161 people

The number who actually took part.

Started

Aug 2024

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Main Period (Period 1) 1. A voluntarily signed and dated Informed Consent form (ICF) of the patient 2. Histologically confirmed squamous cell carcinoma of the head and neck 3. Documented unresectable locoregional recurrence or distant metastases, or progression after prior chemoradiotherapy or combination therapy completed \>3 months before screening, not amenable to local treatment (except cases with high risk of tumor lysis or bleeding), or newly diagnosed metastatic disease not previously treated with systemic therapy. Study treatment is first-line therapy 4. At least one measurable lesion per RECIST 1.1 5. Karnofsky performance status ≥70% 6. Screening laboratory values within the following limits (per local lab normal ranges): * Hemoglobin ≥90 g/L * Leukocytes ≥3.0 × 10\^9/L * Neutrophils ≥1.5 × 10\^9/L * Platelets ≥100 × 10\^9/L * Total bilirubin ≤2 × Upper Limit of Normal (ULN) * Aspartate aminotransferase (AST) ≤3 × ULN * Alanine aminotransferase (ALT) ≤3 × ULN * Estimated glomerular filtration rate (eGFR) ≥60 mL/min 7. Men and women of childbearing potential, and women within 2 years of menopause, must agree to use reliable contraception from informed consent through at least 6 months after study treatment; women of childbearing potential must have a negative urine pregnancy test. Women with no reproductive potential (≥2 years post-menopause or surgically sterile) are exempt 8. Ability and willingness to comply with study protocol and procedures for the planned duration of participation Maintenance Therapy Period (Period 2) 1. Registered objective response (stable disease or partial/complete response according to RECIST 1.1 criteria) to the therapy administered during the main study period 2. Ability and willingness to provide written informed consent for participation in Period 2 3. Karnofsky performance status ≥ 70% 4. Laboratory values within the following limits (per local lab normal ranges): * Hemoglobin ≥ 90 g/L * Leukocytes ≥ 3.0 × 10\^9/L * Neutrophils ≥ 1.5 × 10\^9/L * Platelets ≥ 100 × 10\^9/L * Total bilirubin ≤ 2 × ULN (upper limit of normal) * AST ≤ 3 × ULN * ALT ≤ 3 × ULN * eGFR ≥ 60 mL/min 5. Men and women of childbearing potential, and women within 2 years of menopause, must agree to use reliable contraception from informed consent through at least 6 months after study treatment; women of childbearing potential must have a negative urine pregnancy test. Women with no reproductive potential (≥2 years post-menopause or surgically sterile) are exempt Exclusion Criteria: Main Period (Period 1) 1. Prior therapy with cetuximab or other monoclonal antibody-based biologics 2. Chemotherapy, radiotherapy, or surgery for head and neck cancer within 3 months before screening 3. Any other surgery (except biopsy, implantable venous port placement, or urgent non-cancer surgery) within 3 months before screening 4. Nasopharyngeal carcinoma 5. Other malignancy within the past 5 years or prior/concurrent squamous cell carcinoma (except cured in situ ductal carcinoma, cervical carcinoma in situ, basal cell or squamous cell skin cancer) 6. Expected survival \< 3 months 7. Women who are pregnant or breastfeeding, or unwilling to use effective contraception during the study and for at least 6 months after 8. Significant cardiovascular disease per investigator, including uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥130 mmHg), coronary artery disease, myocardial infarction within 12 months, high-risk uncontrolled arrhythmias, or uncontrolled heart failure 9. Active infection requiring systemic antibiotic therapy 10. Ongoing systemic immunotherapy, hormone therapy, or other cancer treatments not specified in the protocol within 6 months prior to screening or during the study 11. Known or suspected brain metastases, including parenchymal, leptomeningeal, or dural involvement associated with symptoms 12. Positive screening for HBsAg, anti-HCV, anti-HIV1/2 antibodies, or syphilis within 3 months prior to screening 13. Conditions preventing compliance with the study protocol per investigator 14. Participation in another investigational drug study within 6 months prior to screening 15. Unstable medical conditions, including uncontrolled diabetes, psychiatric disorders, or uncontrolled seizures, that could interfere with protocol adherence 16. Known hypersensitivity to any component of study therapy or combination chemotherapy drugs 17. Excessive alcohol use (\>10 standard drinks/week) or history of alcoholism or substance abuse associated with symptoms. One standard drink = 250 mL beer, 125 mL wine, or 30 mL spirits Maintenance Therapy Period (Period 2) 1. Absence of a confirmed objective response to the administered therapy during the main study period, defined as failure to achieve disease stabilization or a partial/complete response according to RECIST v1.1 2. Women who are pregnant or breastfeeding, or unwilling to use effective contraception during the study and for at least 6 months after 3. Significant cardiovascular disease per investigator, including uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥130 mmHg), coronary artery disease, myocardial infarction within 12 months, high-risk uncontrolled arrhythmias, or uncontrolled heart failure 4. Active infection requiring systemic antibiotics 5. Ongoing systemic immunotherapy, hormone therapy, or other cancer treatments not specified in the protocol for Period 2 6. Known or suspected brain metastases, including parenchymal, leptomeningeal, or dural involvement associated with symptoms 7. Conditions preventing compliance with study procedures per investigator 8. Participation in another investigational drug study 9. Unstable medical conditions, including uncontrolled diabetes, psychiatric disorders, or uncontrolled seizures, that could interfere with protocol adherence 10. Excessive alcohol use (\>10 standard drinks/week) or history of alcoholism or substance abuse associated with symptoms. One standard drink = 250 mL beer, 125 mL wine, or 30 mL spirits

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Head and neck squamous cell carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma

Contacts and locations

Locations

  • Branch of the Limited Liability Company "Hadassah Medical Ltd." (LLC Branch "Hadassah Medical")

    Moscow, 121205, Russia

  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncological Dispensary"

    Omsk, 644013, Russia

  • Budgetary Healthcare Institution of the Udmurt Republic "Sergey Grigoryevich Primushko Republican Clinical Oncological Dispensary" of the Ministry of Health of the Udmurt Republic

    Izhevsk, 571207, Russia

  • Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation (Sechenov University)

    Moscow, 119435, Russia

  • Federal State Autonomous Institution "National Medical Research Center 'Medical and Rehabilitation Center'" of the Ministry of Health of the Russian Federation

    Moscow, 125367, Russia

  • Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation

    Tomsk, 634028, Russia

  • Federal State Budgetary Institution "N.N. Burdenko Main Military Clinical Hospital" of the Ministry of Defense of the Russian Federation

    Moscow, 105094, Russia

  • Federal State Budgetary Institution "National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation

    Rostov-on-Don, 344037, Russia

  • Federal State Budgetary Institution "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation, Branch: A.F. Tsyba Medical Radiological Research Center

    Obninsk, 249036, Russia

  • 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, Russia

  • Joint-Stock Company "Medsi Group of Companies"

    Moscow, 143442, Russia

  • Kirov Regional State Clinical Budgetary Healthcare Institution "Center of Oncology and Medical Radiology"

    Kirov, 610045, Russia

  • Limited Liability Company "EuroCityClinic"

    Saint Petersburg, 197022, Russia

  • Limited Liability Company Medical and Sanitary Unit "Clinician-Pretor Clinic"

    Novosibirsk, 630091, Russia

  • Private Healthcare Institution "RZD-Medicine Clinical Hospital" of Saint Petersburg

    Saint Petersburg, 195271, Russia

  • Private Medical Institution "Euromedservice"

    Pushkin, 196603, Russia

  • Regional Budgetary Healthcare Institution "Ivanovo Regional Oncological Dispensary"

    Ivanovo, 153040, Russia

  • Republican Specialized Scientific and Practical Medical Center of Oncology and Radiology, Tashkent Regional Branch

    Tashkent, 100128, Uzbekistan

  • Saint Petersburg State Budgetary Healthcare Institution "City Clinical Oncological Dispensary"

    Saint Petersburg, 197022, Russia

  • State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary" of the Ministry of Health of the Republic of Bashkortostan

    Ufa, 450054, Russia

  • 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, Russia

  • State Autonomous Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Oncology Dispensary"

    Yekaterinburg, 620036, Russia

  • State Autonomous Healthcare Institution of the Nizhny Novgorod Region "Research Institute of Clinical Oncology 'Nizhny Novgorod Regional Clinical Oncology Dispensary'"

    Nizhny Novgorod, 603081, Russia

  • State Budgetary Healthcare Institution "Clinical Oncological Dispensary No. 1" of the Ministry of Health of Krasnodar Krai

    Krasnodar, 350040, Russia

  • State Budgetary Healthcare Institution "Kuzbass Clinical Oncology Dispensary named after M.S. Rappoport" (SBHI "KCOD")

    Kemerovo, 650036, Russia

  • State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"

    Kuz'molovskiy, 191104, Russia

  • State Budgetary Healthcare Institution "Regional Oncological Dispensary"

    Irkutsk, 664035, Russia

  • State Budgetary Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncological Dispensary"

    Arkhangelsk, 163045, Russia

  • State Budgetary Healthcare Institution of Kaluga Region "Kaluga Regional Clinical Oncology Dispensary"

    Kaluga, 248007, Russia

  • State Budgetary Healthcare Institution of Moscow "A.S. Loginov Moscow Clinical Scientific and Practical Center" of the Moscow Department of Health

    Moscow, 111123, Russia

  • State Budgetary Healthcare Institution of Moscow "City Clinical Hospital named after S.S. Yudin, Department of Health of Moscow"

    Moscow, 129090, Russia

  • State Budgetary Healthcare Institution of Moscow "Moscow City Oncological Hospital No. 62, Department of Health of Moscow"

    Istra, 143515, Russia

  • State Budgetary Healthcare Institution of Stavropol Krai "Pyatigorsk Interdistrict Oncology Dispensary"

    Pyatigorsk, Russia

  • State Budgetary Healthcare Institution of Yaroslavl Region "Regional Clinical Oncological Hospital"

    Yaroslavl, 150054, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.