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

NCT ID NCT07435311

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

First seen Jun 25, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This Phase 1 trial compared a new biosimilar drug, RPH-002, to the standard cancer drug Erbitux in 118 patients with advanced head and neck cancer that could not be removed by surgery. The main goals were to see if RPH-002 reaches similar levels in the blood and has a similar safety profile when given with chemotherapy. This is an early step to see if a more affordable option might be possible.

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 version of cetuximab, a targeted cancer drug)
What this could lead to: If RPH-002 works as well as Erbitux, it could offer a more affordable treatment option for advanced head and neck cancer.
What could go wrong: This is an early Phase 1 study focused on drug levels and safety, not on proving the drug works. The trial is small and may not show a clear benefit.

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

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

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

Autonomous Institution of the Chuvash Republic "Republican Clinical Oncological Dispensary" of the Ministry of Health of the Chuvash Republic

Cheboksary, 428020, Russia
Budgetary Healthcare Institution of Omsk Region "Clinical Oncological Dispensary"

Omsk, 644013, Russia
Federal State Autonomous Higher Education Institution "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 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
Joint-Stock Company "Medsi Group of Companies"

Moscow, 143442, Russia
Limited Liability Company "COMPAS-LA"

Moscow, 119602, Russia
Private Medical Institution "Euromedservice"

Pushkin, 196603, Russia
Regional Budgetary Healthcare Institution "Ivanovo Regional Oncological Dispensary"

Ivanovo, 153040, Russia
Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary"

Barnaul, 656045, Russia
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 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 Kaluga Region "Kaluga Regional Clinical Oncological Dispensary"

Kaluga, 248007, 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 Novosibirsk Region "Novosibirsk Regional Clinical Oncological Dispensary"

Novosibirsk, 630108, 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.