New hope for head and neck cancer: experimental drug petosemtamab enters final testing

NCT ID NCT06496178

Disease control Sponsor: Merus B.V. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This Phase 3 trial tests a new drug called petosemtamab against standard treatments (cetuximab, methotrexate, or docetaxel) in 600 adults with advanced head and neck cancer that has spread or come back. Participants must have already tried immunotherapy and chemotherapy. The main goal is to see if petosemtamab helps people live longer.

What this could mean

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

Active substance: Petosemtamab (a lab-made antibody that targets cancer cells)
What this could lead to: If it works, this could offer a new treatment option for people with advanced head and neck cancer who have run out of standard therapies.
What could go wrong: This is an early-stage Phase 3 trial, so results are not guaranteed. The drug may not improve survival or could have side effects like infusion reactions or infections.

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

621 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

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: * Signed ICF before initiation of any study procedures. * Age ≥ 18 years at signing of ICF. * Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent. * HNSCC participants progressed on or after anti-PD-1 therapy and platinum-containing therapy. * The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. * A baseline new tumor sample unless the participant has an available tumor sample as an FFPE block with sufficient material. * Measurable disease as defined by RECIST v1.1 by radiologic methods. * ECOG PS of 0 or 1 * Life expectancy ≥ 12 weeks, as per investigator * Adequate organ function (as per protocol) Exclusion Criteria: * Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days prior to randomization. * Known leptomeningeal involvement * Any systemic anticancer therapy within 4 weeks prior to randomization. * Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to randomization. * Persistent Grade \>1 clinically significant toxicities related to prior antineoplastic therapies * History of hypersensitivity reaction to any of the excipients of treatment required for this study. * Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry * History of prior malignancies with the exception of localized cancer with curative resection (e.g. cervical intraepithelial neoplasia or nonmelanoma skin cancer) * Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy * Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders * Participants with known infectious diseases (as per protocol) * Pregnant or breastfeeding participants

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Get notified about this study

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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

Site 1

Jerusalem, 9112001, Israel
Site 10

Blacksburg, Virginia, 24060, United States
Site 100

New Orleans, Louisiana, 70121, United States
Site 102

Prescott, Arizona, 86301, United States
Site 103

Ann Arbor, Michigan, 48109, United States
Site 104

Washington D.C., District of Columbia, 20010, United States
Site 105

Bordeaux, 33075, France
Site 106

Montpellier, 34298, France
Site 107

Rouen, 76038, France
Site 108

Liège, 4000, Belgium
Site 109

Madrid, 28040, Spain
Site 11

Saint Leonards, 2065, Australia
Site 110

Rosario, S2000KZE, Argentina
Site 111

Cuneo, 12100, Italy
Site 112

Hanover, 30625, Germany
Site 113

Villejuif, 94800, France
Site 114

Paris, 75005, France
Site 115

Marseille, 13005, France
Site 116

Leipzig, 04103, Germany
Site 117

Poznan, 60-185, Poland
Site 118

Lyon, 69373, France
Site 119

Toulouse, 31059, France
Site 12

Fort Myers, Florida, 33901, United States
Site 120

Heraklion, 71500, Greece
Site 121

Berlin, 12203, Germany
Site 122

Durham, North Carolina, 27710, United States
Site 123

Jacksonville, Florida, 32224, United States
Site 124

Rochester, Minnesota, 55905, United States
Site 125

Scottsdale, Arizona, 85054, United States
Site 126

Rio, 26504, Greece
Site 127

Sacramento, California, 95817, United States
Site 128

Milan, 20133, Italy
Site 13

Goyang-si, 10408, South Korea
Site 130

Lone Tree, Colorado, 80124, United States
Site 131

Kashiwa, 277-8577, Japan
Site 132

Chūōku, 104-0045, Japan
Site 133

Ōsaka-sayama, 589-8511, Japan
Site 134

Sendai, 980-8574, Japan
Site 135

Miki, 761-0793, Japan
Site 136

Poitiers, 86000, France
Site 137

Seoul, 03080, South Korea
Site 138

Tampa, Florida, 33612, United States
Site 139

Nagoya, 464-8681, Japan
Site 14

Ramat Gan, 5265601, Israel
Site 140

London, EC1A 7BE, United Kingdom
Site 141

Rennes, 35042, France
Site 142

Vandœuvre-lès-Nancy, 54519, France
Site 143

Gdansk, 80-214, Poland
Site 144

São Paulo, 04538-132, Brazil
Site 145

Porto Alegre, 90110-270, Brazil
Site 146

Recife, 50040-000, Brazil
Site 147

São Paulo, 01509-900, Brazil
Site 148

Rio de Janeiro, 22281-100, Brazil
Site 149

Lille, 59000, France
Site 15

Albuquerque, New Mexico, 87131, United States
Site 150

Porto Alegre, 90610-000, Brazil
Site 151

Bensalem, Pennsylvania, 19020, United States
Site 152

Chicago, Illinois, 60607, United States
Site 153

Columbia, Maryland, 21044, United States
Site 154

Brasília, 70390-140, Brazil
Site 156

Winchester, Virginia, 22601, United States
Site 157

London, E20 1JQ, United Kingdom
Site 158

Philadelphia, Pennsylvania, 19107, United States
Site 159

Philadelphia, Pennsylvania, 19114, United States
Site 16

Providencia, 7500859, Chile
Site 160

Mobile, Alabama, 36608, United States
Site 161

Busan, 48108, South Korea
Site 162

Le Mans, 72000, France
Site 163

Seattle, Washington, 98109, United States
Site 164

Suwon, 16499, South Korea
Site 165

Essen, 45147, Germany
Site 166

Madrid, 28050, Spain
Site 167

Paris, 75013, France
Site 168

München, 81675, Germany
Site 169

Nice, 06189, France
Site 17

Kaohsiung City, 807, Taiwan
Site 170

Herston, 4060, Australia
Site 171

Glasgow, G12 0YN, United Kingdom
Site 172

Montreal, H2X 0A9, Canada
Site 173

Orange, California, 92868, United States
Site 174

Cardiff, CF14 2TL, United Kingdom
Site 176

Tainan, 70428, Taiwan
Site 177

Krakow, 31-826, Poland
Site 178

Sankt Gallen, 9007, Switzerland
Site 179

Warsaw, 02-781, Poland
Site 18

St Louis, Missouri, 63110, United States
Site 180

Kaunas, 50161, Lithuania
Site 181

Vilnius, 08406, Lithuania
Site 182

Coimbra, 3004-561, Portugal
Site 183

Lisbon, 1998-018, Portugal
Site 184

Bellinzona, CH-6500, Switzerland
Site 185

Porto, 4200-072, Portugal
Site 186

Natori, 981-1293, Japan
Site 187

Atlanta, Georgia, 30322, United States
Site 188

Nový Jičín, 74101, Czechia
Site 189

Geneva, 1211, Switzerland
Site 19

Haifa, 3109601, Israel
Site 190

Bydgoszcz, 85-796, Poland
Site 191

Newcastle upon Tyne, NE7 7DN, United Kingdom
Site 192

Fukuoka, 812-8582, Japan
Site 193

CABA, Clll3AAE, Argentina
Site 194

Lausanne, 1011, Switzerland
Site 195

Pécs, 7624, Hungary
Site 196

Toronto, M4N 3M5, Canada
Site 197

Portimão, 8500-338, Portugal
Site 198

Szeged, 6725, Hungary
Site 199

Fukuoka, 810-8563, Japan
Site 2

Tel Aviv, 6423906, Israel
Site 20

Recoleta, 8420000, Chile
Site 200

Lodz, 93-513, Poland
Site 201

Olomouc, 779 00, Czechia
Site 203

Roma, 00161, Italy
Site 204

Nyíregyháza, 4400, Hungary
Site 205

Minatoku, 105-8471, Japan
Site 206

Seongnam-si, 13620, South Korea
Site 207

Atlanta, Georgia, 30341, United States
Site 208

Seoul, 07061, South Korea
Site 209

Naples, 80131, Italy
Site 21

Santiago, 7560908, Chile
Site 210

Dresden, 01307, Germany
Site 211

Brest, 29200, France
Site 213

Chicago, Illinois, 60611, United States
Site 214

The Bronx, New York, 10461, United States
Site 215

Busan, 49267, South Korea
Site 216

Madison, Wisconsin, 53705, United States
Site 217

Nagoya, Aichi-ken, 466-8560, Japan
Site 218

Cleveland, Ohio, 44106, United States
Site 22

Charlottesville, Virginia, 22908, United States
Site 23

Cincinnati, Ohio, 45219, United States
Site 24

New York, New York, 10029, United States
Site 25

La Jolla, California, 92037, United States
Site 26

Portland, Oregon, 97213, United States
Site 27

Santiago, 7500921, Chile
Site 28

Palo Alto, California, 94304, United States
Site 29

Hwasun, 58128, South Korea
Site 3

Darlinghurst, 2010, Australia
Site 30

Nedlands, 6009, Australia
Site 31

Indianapolis, Indiana, 46202, United States
Site 32

Columbus, Ohio, 43210, United States
Site 33

Soeul, 03722, South Korea
Site 34

El Paso, Texas, 79915, United States
Site 35

Taipei, 112, Taiwan
Site 36

Seoul, 05505, South Korea
Site 38

Melbourne, 3000, Australia
Site 39

Taipei, 100, Taiwan
Site 4

Salt Lake City, Utah, 84112, United States
Site 40

Baton Rouge, Louisiana, 70809, United States
Site 42

London, SW3 6JJ, United Kingdom
Site 43

Sutton, SM2 5PT, United Kingdom
Site 44

Liverpool, L7 8YA, United Kingdom
Site 45

Córdoba, X5008HHW, Argentina
Site 46

San Francisco, California, 94158, United States
Site 47

Seoul, 06351, South Korea
Site 48

Manchester, M20 4BX, United Kingdom
Site 49

Maple Grove, Minnesota, 55369, United States
Site 5

Detroit, Michigan, 48201, United States
Site 50

Charleston, South Carolina, 29425, United States
Site 51

Houston, Texas, 77030, United States
Site 52

Taoyuan City, 333, Taiwan
Site 53

Taichung, 40447, Taiwan
Site 54

Memphis, Tennessee, 38103, United States
Site 55

Denison, Texas, 75020, United States
Site 56

Brussels, 1200, Belgium
Site 57

Viedma, 8500, Argentina
Site 58

Caba, C1280AEB, Argentina
Site 59

Nashville, Tennessee, 37203, United States
Site 6

Spokane, Washington, 99202, United States
Site 60

Chattanooga, Tennessee, 37404, United States
Site 61

Nijmegen, 6525 GA, Netherlands
Site 62

Greifswald, 17475, Germany
Site 63

Pamplona, 31008, Spain
Site 64

Pamplona, 31008, Spain
Site 65

Cambridge, CB2 0QQ, United Kingdom
Site 66

Utrecht, 3584 CX, Netherlands
Site 67

Nashville, Tennessee, 37232, United States
Site 68

Chicago, Illinois, 60637, United States
Site 69

Namur, 5000, Belgium
Site 7

Houston, Texas, 77030, United States
Site 70

Middlesex, HA6 2RN, United Kingdom
Site 71

Madrid, 28041, Spain
Site 72

Leuven, 3000, Belgium
Site 73

Sydney, 2050, Australia
Site 74

Valencia, 46009, Spain
Site 75

Madrid, 28040, Spain
Site 76

Amsterdam, 1066 CX, Netherlands
Site 77

Boston, Massachusetts, 02215, United States
Site 78

Barcelona, 08035, Spain
Site 79

Hamburg, 20246, Germany
Site 8

Louisville, Kentucky, 40202, United States
Site 81

Milan, 20141, Italy
Site 82

Duarte, California, 91010, United States
Site 83

Thessaloniki, 55236, Greece
Site 84

Giessen, 35390, Germany
Site 85

Rozzano, 20089, Italy
Site 86

Hackensack, New Jersey, 07601, United States
Site 87

Cleveland, Ohio, 44195, United States
Site 89

Naples, 80131, Italy
Site 9

Orlando, Florida, 32827, United States
Site 90

London, SE1 9RT, United Kingdom
Site 91

Athens, 124 62, Greece
Site 92

Ghent, 9000, Belgium
Site 93

Brescia, 25123, Italy
Site 94

Pearland, Texas, 77584, United States
Site 95

Kaohsiung City, 833, Taiwan
Site 96

Athens, 15123, Greece
Site 97

Gliwice, 44-102, Poland
Site 98

Chapel Hill, North Carolina, 27514, United States
Site 99

Würzburg, 97080, Germany

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