Trial: A Phase 3 Study to Evaluate Petosemtama…

Trial Details

Sponsor: Merus N.V. (industry)

Phase: 3

Start date: Sept. 25, 2024

Planned enrollment: 500

Trial ID: NCT06525220

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: Petosemtamab (MCLA-158)

Overview

Petosemtamab (MCLA-158) is an investigational bispecific antibody being studied for several advanced cancers. The most substantial reported human results are from single-arm phase 2 studies in recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), both alone after prior treatment and with pembrolizumab as first-line treatment. These studies show antitumor activity but cannot establish how much benefit petosemtamab adds over existing treatments. (annalsofoncology.org)

Mechanism of action

Petosemtamab binds EGFR and LGR5, a marker found on some stem-like cancer cells. Preclinical research indicates that binding both targets can promote EGFR degradation in LGR5-positive cells, suppress EGFR signaling, and recruit immune cells through antibody-dependent cellular cytotoxicity. Whether these mechanisms account for clinical benefit remains under investigation. (nature.com)

Efficacy

Previously treated HNSCC: An investigator-assessed, single-arm phase 2 analysis reported tumor responses in 19 of 47 evaluable patients (40.4%) receiving petosemtamab alone. Median response duration was 7.2 months. (annalsofoncology.org)
First-line, PD-L1-positive HNSCC: A 2025 phase 2 conference abstract reported responses in 26 of 43 evaluable patients (60%) receiving petosemtamab plus pembrolizumab, including five complete responses; median response duration was 11 months. A subsequently updated investigator assessment reported 27 of 43 (63%), including six complete responses. (asco.org)
Metastatic colorectal cancer: Preliminary phase 2 cohorts were small and had short follow-up. Responses were reported with chemotherapy combinations, while one of 14 evaluable patients receiving later-line petosemtamab alone had an unconfirmed partial response. (aacrjournals.org)

Safety

In a previously treated HNSCC cohort, commonly reported adverse events included acneiform dermatitis, decreased magnesium, rash, and infusion-related reactions. In the first-line combination cohort of 45 patients, 27 (60%) had a grade 3 or higher treatment-emergent adverse event, and 20 (44%) had one considered treatment-related. Infusion-related reactions occurred in 38%, including grade 3 reactions in 7%. Adverse-event figures include events not necessarily caused by petosemtamab. (annalsofoncology.org)

TrialFetch AI Analysis

Goal: Determine whether adding petosemtamab to first-line pembrolizumab improves survival and tumor response in recurrent or metastatic PD-L1–positive head and neck squamous cell carcinoma (HNSCC), while assessing safety.

Patients: Adults with measurable, incurable recurrent or metastatic HNSCC arising in the oropharynx, oral cavity, hypopharynx, or larynx; PD-L1 combined positive score ≥1; and ECOG performance status 0–1. Prior systemic therapy for incurable recurrent or metastatic disease is not permitted. Prior anti–PD-(L)1 therapy is excluded, as is prior anti-EGFR therapy except cetuximab given with radiotherapy if progression occurred more than one year after its last dose.

Design: Randomized, open-label comparison of two first-line treatment arms. Objective response is assessed by blinded independent central review despite the open-label design.

Treatments: The experimental arm receives petosemtamab plus pembrolizumab; the comparator receives pembrolizumab alone, an established first-line immunotherapy option for eligible PD-L1–positive HNSCC. Petosemtamab is an investigational bispecific antibody targeting EGFR and LGR5; preclinical work suggests it can promote EGFR degradation in LGR5-positive cells and recruit immune effector cells. In a single-arm first-line phase 2 cohort, the combination produced investigator-assessed responses in 27 of 43 evaluable patients (63%), but its added benefit over pembrolizumab alone remains unproven.

Outcomes: Co-primary endpoints are overall survival, followed for approximately three years, and RECIST v1.1 objective response rate by blinded independent central review, followed for approximately two years. Secondary measures include progression-free survival, duration of response, clinical benefit, investigator-assessed efficacy, treatment-emergent adverse events, patient-reported quality of life, pharmacokinetics, and anti-drug antibodies.

Burden on patient: Moderate. Participants undergo repeated treatment visits, imaging and safety assessments, and quality-of-life evaluations; pharmacokinetic sampling occurs during the first six cycles. A new tumor biopsy may be required if sufficient archival tissue is unavailable. The combination arm adds an investigational treatment and potentially more treatment-related monitoring than pembrolizumab alone, although visit and scan frequencies are not specified.

Last updated: Sep 2026

Eligibility

Caution: ClinicalTrials.gov appears to have newer eligibility criteria than the version saved here. Review the current criteria in ClinicalTrials.gov.

Show Criteria

Inclusion Criteria:

1. Signed ICF before initiation of any study procedures

2. Age ≥ 18 years at signing of ICF

3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.

4. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.

5. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1.

6. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting

7. A new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material

8. Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods

9. ECOG Performance Status (PS) of 0-1

10. Life expectancy ≥ 12 weeks, as per investigator assessment.

11. Left ventricular ejection fraction (LVEF) ≥50% or ≥ institutional normal limit, whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan

12. Adequate organ function as defined per protocol.

13. HIV-positive patients are eligible only if the cluster of differentiation 4 (CD4+) count is ≥ 300/µl, viral load is undetectable, and the patient is currently receiving highly active antiretroviral therapy

Exclusion Criteria:

1. Central nervous system metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 21 days prior to randomization

2. Known leptomeningeal involvement

3. Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization

4. Requirement for immunosuppressive medication

5. Major surgery or radiotherapy within 3 weeks of randomization

6. Clinically significant toxicities related to prior anticancer therapies that have not returned to ≤ Grade 1 or baseline except for Grade ≤2- myalgia, neuropathy, alopecia, and any prior therapy related endocrinopathies

7. History of hypersensitivity reaction to any of the excipients of petosemtomab or pembrolizumab.

8. 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 prior to randomization

9. History of prior malignancies within the last 5 years, with the exception of excised local cancer

10. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy

11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders

12. Patients with known infectious diseases as per protocol.

13. Pregnant or breastfeeding patients.

14. The patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy of prednisone \>10 mg/day or equivalent, or any other form of immunosuppressive therapy

15. The patient has an active autoimmune disease that has required systemic immune suppressive treatment in the past 2 years; replacement therapy is not considered immune suppressive treatment

16. The patient has had an allogeneic tissue/solid organ transplant.

17. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)

Other protocol defined inclusion/exclusion criteria may apply.

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Providencia, 7500859, Chile

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Prague, 150 06, Czechia

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Olomouc, 779 00, Czechia

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Le Mans, 72000, France

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Mannheim, 68167, Germany

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Ulm, 89075, Germany

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Bonn, 53175, Germany

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Dortmund, 44137, Germany

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Tübingen, 72076, Germany

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Hamburg, 22763, Germany

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Panórama, 55236, Greece

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Chaïdári, 12462, Greece

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Pátrai, Achaia, 265 04, Greece

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Athens, Attica, 151 23, Greece

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Heraklion, Crete, 715 00, Greece

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Szeged, 6720, Hungary

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Pécs, 7624, Hungary

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Nyíregyháza, 4400, Hungary

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Ramat Gan, 5266202, Israel

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Jerusalem, 9112001, Israel

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Tel Aviv, 6423906, Israel

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Haifa, 3109601, Israel

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Milan, 20133, Italy

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Meldola, 47014, Italy

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Naples, 80131, Italy

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Cagliari, 09121, Italy

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Rome, 00161, Italy

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Milan, 20141, Italy

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Rozzano, 20089, Italy

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Ancona, 60126, Italy

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Naples, 80131, Italy

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Brescia, 25123, Italy

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Nagoya, Aichi-ken, 464-8681, Japan

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Kashiwa, Chiba, 277-8577, Japan

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Fukuoka, Fukuoka, 810-8563, Japan

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Hiragi, Kagawa-ken, 761-0793, Japan

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Sendai, Miyagi, 960-8574, Japan

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Natori-shi, Miyagi, 981-1293, Japan

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Ōsaka-sayama, Osaka, 589-8511, Japan

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Chuo Ku, Tokyo, 104-0045, Japan

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Minato-Ku, Tokyo, 105-8471, Japan

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Vilnius, 08406, Lithuania

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Kaunas, 50161, Lithuania

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Kuching, 93586, Malaysia

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Putrajaya, 62250, Malaysia

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Johor Bahru, 81100, Malaysia

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Nijmegen, 6525 GA, Netherlands

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Utrecht, 3584 CX, Netherlands

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Amsterdam, 1066 CX, Netherlands

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Gliwice, 44-102, Poland

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Krakow, 31-826, Poland

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Gdansk, 80-214, Poland

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Bydgoszcz, 85-796, Poland

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Warsaw, 02-781, Poland

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Lodz, 93-513, Poland

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Coimbra, 3004-561, Portugal

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Porto, 4200-072, Portugal

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Portimão, 8500-338, Portugal

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Lisbon, 1998-018, Portugal

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Goyang-si, 10408, South Korea

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Busan, 48108, South Korea

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Suwon, 16499, South Korea

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Seoul, 03722, South Korea

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Seoul, 03722, South Korea

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Suwon, 16247, South Korea

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Seoul, 05505, South Korea

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Hwasun, 58128, South Korea

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Badalona, 08916, Spain

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Madrid, 28040, Spain

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Madrid, 28050, Spain

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Pamplona, 31008, Spain

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Pamplona, 31008, Spain

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Madrid, 28041, Spain

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Marbella, 29660, Spain

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Valencia, 46009, Spain

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Madrid, 28040, Spain

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Barcelona, 08035, Spain

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Kaohsiung City, 833, Taiwan

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Taipei, 112, Taiwan

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Taipei, 100, Taiwan

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Kaohsiung City, 80756, Taiwan

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Changhua, 500, Taiwan

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Taoyuan, 333, Taiwan

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Taichung, 40447, Taiwan

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Chiang Rai, 57000, Thailand

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Pathum Wan, Bangkok, 10330, Thailand

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Bangkok Noi, Bangkok, 10700, Thailand

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Ratchathewi, Bangkok, 10400, Thailand

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Hat Yai, Changwat Songkhla, 90110, Thailand

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Antalya, 07025, Turkey (Türkiye)

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Ankara, 06230, Turkey (Türkiye)

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Istanbul, 34722, Turkey (Türkiye)

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Ankara, 06170, Turkey (Türkiye)

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Cambridge, CB20QQ, United Kingdom

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London, EC1A 7BE, United Kingdom

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Taunton, TA1 5DA, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Cardiff, CF14 2TL, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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London, SW3 6JJ, United Kingdom

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Sutton, SM2 5PT, United Kingdom

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Northwood, HA62RN, United Kingdom

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London, SE19RT, United Kingdom

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Mobile, Alabama, 36607, United States

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Palo Alto, California, 94304, United States

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Los Angeles, California, 90033, United States

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La Jolla, California, 92037, United States

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Newark, Delaware, 19713, United States

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

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Fort Myers, Florida, 33901, United States

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West Palm Beach, Florida, 33401, United States

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St. Petersburg, Florida, 33705, United States

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Orlando, Florida, 32827, United States

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Atlanta, Georgia, 30322, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60637, United States

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Louisville, Kentucky, 40202, United States

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Baton Rouge, Louisiana, 70809, United States

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Minneapolis, Minnesota, 55417, United States

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St Louis, Missouri, 63108, United States

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Hackensack, New Jersey, 07601, United States

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Albuquerque, New Mexico, 87131, United States

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Durham, North Carolina, 27710, United States

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Winston-Salem, North Carolina, 27157, United States

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Cleveland, Ohio, 44195, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19114, United States

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Philadelphia, Pennsylvania, 19104, United States

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Memphis, Tennessee, 38103, United States

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Nashville, Tennessee, 37203, United States

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Chattanooga, Tennessee, 37404, United States

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Houston, Texas, 77030, United States

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Tyler, Texas, 75702, United States

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Sugar Land, Texas, 77479, United States

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Plano, Texas, 75075, United States

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Austin, Texas, 78745, United States

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Salt Lake City, Utah, 84112, United States

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Blacksburg, Virginia, 24060, United States

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Norfolk, Virginia, 23502, United States

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CABA, C1125ABD, Argentina

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Gyeonggi-do, 13496, South Korea

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Orlando, Florida, 32804, United States

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A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma

Trial Details

Show Summary from Sponsor

More details:

Investigational Drug AI Analysis

Show for: Petosemtamab (MCLA-158)

Overview

Mechanism of action

Efficacy

Safety

Further reading

TrialFetch AI Analysis

Eligibility

Show Criteria

Sites (197)

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