Trial: A Phase 3 Study to Evaluate Petosemtama…

Trial Details

Sponsor: Merus N.V. (industry)

Phase: 3

Start date: June 25, 2024

Planned enrollment: 500

Trial ID: NCT06496178

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, ADCC‑enhanced, full‑length bispecific IgG1 antibody that targets EGFR and LGR5. It is being developed primarily for recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC), with ongoing phase 2 and phase 3 development; the FDA has granted Breakthrough Therapy designation for post–PD‑1/platinium r/m HNSCC (May 2024) and for the first‑line combination with pembrolizumab in PD‑L1–positive disease (February 2025). (aacrjournals.org)

Mechanism of action

Dual targeting of EGFR and LGR5 on tumor cells; binding blocks EGFR ligand engagement and, when both targets are present, promotes LGR5‑mediated internalization and degradation of EGFR. The Fc region is engineered for enhanced innate immune effector functions (ADCC/ADCP). (pubmed.ncbi.nlm.nih.gov)

Efficacy

Monotherapy (phase 1/2, expansion cohort, previously treated r/m HNSCC): Among 43 evaluable patients, overall response rate (ORR) was 37.2% with median duration of response (DOR) 6.0 months (data cutoff Feb 1, 2023; AACR 2023). (aacrjournals.org)
First‑line combination with pembrolizumab (phase 2 expansion, PD‑L1 CPS ≥1 r/m HNSCC):
Early ASCO 2024 readout (n=24 evaluable): investigator‑assessed ORR 67%. (merus.gcs-web.com)
Updated 2025 interim analysis (data cutoff Feb 27, 2025; n=43 evaluable): confirmed ORR 63% (6 CR, 21 PR); median PFS 9.0 months (95% CI 5.2–12.9); 12‑month overall survival rate 79%; median DOR and OS not reached. Responses were observed across PD‑L1 levels (CPS 1–19: 47%; CPS ≥20: 73%). (ir.merus.nl)
Study design and initial safety run‑in details were presented at ASCO 2024 (NCT03526835). (ascopubs.org)

Note: Phase 3 trials in first‑line PD‑L1+ and in post‑PD‑1 settings have been initiated/planned by the sponsor based on these data. For current recruitment/status, see the study record for NCT03526835 and sponsor updates. (fdaaa.trialstracker.net)

Safety

Monotherapy (AACR 2023, n=78 at RP2D across escalation/expansion): most frequent adverse events (all grades/grade 3–4) included rash (33%/0%), hypotension (26%/6%), dyspnea (26%/4%), nausea (26%/1%), acneiform dermatitis (24%/1%), hypomagnesemia (19%/5%); infusion‑related reactions (IRRs) in 74%/21% (mostly first infusion; 6% discontinued due to IRR). One unrelated grade 5 GI bleed in an esophageal cancer patient. (aacrjournals.org)
First‑line combination with pembrolizumab (ASCO 2024 safety run‑in): no grade 4–5 AEs observed at early cutoff; most AEs were grade 1–2 (e.g., acneiform dermatitis 31%, asthenia 27%, rash 27%); IRRs in 27% (grade 3 in 3.8%, first infusion, resolved). (ascopubs.org)
Updated 2025 interim combination data (n=45 treated): grade ≥3 treatment‑emergent AEs in 60% and grade ≥3 treatment‑related AEs in 44%; IRRs in 38% (grade 3 in 7%), mainly first infusion; no significant overlapping toxicities with pembrolizumab reported. (ir.merus.nl)

TrialFetch AI Analysis

Goal: To determine whether petosemtamab improves objective response rate and overall survival compared with investigator’s choice single‑agent therapy in patients with previously treated, incurable metastatic or recurrent head and neck squamous cell carcinoma (HNSCC).

Patients: Adults (≥18 years) with histologically confirmed HNSCC of the oropharynx, oral cavity, hypopharynx, or larynx, with metastatic or locally advanced disease not amenable to curative therapy. All patients must have progressed on or after both anti–PD‑1 therapy and platinum-containing therapy; if platinum was given only in the adjuvant/multimodal curative setting, progression must have occurred within 6 months of the last platinum dose. Additional key requirements include measurable disease by RECIST v1.1, ECOG 0–1, adequate organ function, and documented p16 status for oropharyngeal primaries. Exclusions include active/untreated CNS disease, leptomeningeal involvement, recent systemic therapy, significant uncontrolled comorbidities, and nasopharyngeal primary.

Design: International, multicenter, open-label, phase 3 randomized controlled trial with approximately 500 participants assigned to petosemtamab or investigator’s choice monotherapy as second- or third-line therapy after PD-1 and platinum. Allocation is randomized; efficacy assessments are by blinded independent central review for imaging endpoints.

Treatments: Experimental: Petosemtamab (MCLA‑158), a human IgG1 bispecific antibody targeting EGFR and LGR5. It blocks ligand binding to EGFR, co-engages LGR5 to drive internalization and degradation of EGFR in LGR5-positive tumor cells, and leverages Fc-mediated effector function for ADCC/ADCP. In phase 1/2 monotherapy cohorts in previously treated r/m HNSCC, confirmed ORR around 36%–40% with median PFS about 5 months and median OS about 11–12.5 months has been reported; infusion-related reactions are common but largely first-infusion and manageable with mitigation. The program has FDA Breakthrough Therapy designation in pretreated r/m HNSCC. Control: Investigator’s choice single-agent standard therapy per local practice (e.g., commonly used monotherapies in this setting), serving as an active comparator.

Outcomes: Co-primary endpoints are objective response rate by blinded independent central review per RECIST v1.1 and overall survival. Key secondary endpoints include PFS by BICR and by investigator, duration of response, time to response, clinical benefit rate, safety and tolerability (TEAEs, serious TEAEs, discontinuations and dose modifications due to AEs), patient-reported outcomes with EORTC QLQ-C30 and QLQ-H&N43, and pharmacokinetics and immunogenicity (ADA).

Burden on patient: Moderate. Requirements include baseline provision of a tumor sample (new biopsy if archival FFPE is insufficient), regular imaging for RECIST assessments, adverse event monitoring, and patient-reported outcome questionnaires. As a phase 3 IV therapy, visit frequency will align with dosing cycles and imaging approximately every 6–9 weeks common in HNSCC studies; added pharmacokinetic and ADA sampling in the first six cycles increases blood draws beyond standard care. Infusion visits, especially the first dose with monitoring for infusion-related reactions, may extend clinic time. Travel burden reflects routine oncology infusion schedules at participating centers without mandatory inpatient stays.

Last updated: Oct 2025

Eligibility

Show Criteria

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 patients 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.

* Documentation of p16 status (positive or negative) by local laboratory IHC for patients with primary oropharyngeal cancer.

* A baseline new tumor sample unless the patient 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 of study entry.

* Known leptomeningeal involvement

* Any systemic anticancer therapy within 4 weeks of the first dose of study treatment.

* Major surgery or radiotherapy within 3 weeks of the first dose of study treatment.

* 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 excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease

* 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

* Patients with known infectious diseases (as per protocol)

* Pregnant or breastfeeding patients

* Patient has a primary tumor site of nasopharynx (any histology).

Sites (180)

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Site 110

Rosario, S2000KZE, Argentina

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Córdoba, X5008HHW, Argentina

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Viedma, 8500, Argentina

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Caba, C1280AEB, Argentina

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Saint Leonards, 2065, Australia

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Herston, 4060, Australia

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Darlinghurst, 2010, Australia

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Nedlands, 6009, Australia

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Melbourne, 3000, Australia

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Sydney, 2050, Australia

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Liège, 4000, Belgium

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Brussels, 1200, Belgium

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Namur, 5000, Belgium

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Leuven, 3000, Belgium

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Ghent, 9000, Belgium

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São Paulo, 04538-132, Brazil

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Porto Alegre, 90110-270, Brazil

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Recife, 50040-000, Brazil

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São Paulo, 01509-900, Brazil

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Rio de Janeiro, 22281-100, Brazil

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Porto Alegre, 90610-000, Brazil

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Brasília, 70390-140, Brazil

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Rio de Janeiro, 22.250-905, Brazil

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Montreal, H2X 0A9, Canada

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Providencia, 7500859, Chile

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Recoleta, 8420000, Chile

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Santiago, 7560908, Chile

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Santiago, 7500921, Chile

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Bordeaux, 33075, France

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Montpellier, 34298, France

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Rouen, 76038, France

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Villejuif, 94800, France

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Paris, 75005, France

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Marseille, 13005, France

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Lyon, 69373, France

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Toulouse, 31059, France

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Poitiers, 86000, France

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Rennes, 35042, France

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Vandœuvre-lès-Nancy, 54519, France

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Lille, 59000, France

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Le Mans, 72000, France

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Paris, 75013, France

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Nice, 06189, France

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Aachen, 52074, Germany

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Hanover, 30625, Germany

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Leipzig, 04103, Germany

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Berlin, 12203, Germany

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Essen, 45147, Germany

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München, 81675, Germany

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Mannheim, 68167, Germany

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Greifswald, 17475, Germany

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Hamburg, 20246, Germany

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Giessen, 35390, Germany

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Hamburg, 22763, Germany

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Würzburg, 97080, Germany

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Heraklion, 71500, Greece

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Rio, 26504, Greece

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Thessaloniki, 55236, Greece

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Athens, 124 62, Greece

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Athens, 15123, Greece

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Jerusalem, 9112001, Israel

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Tel Litwinsky, 5265601, Israel

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Haifa, 3109601, Israel

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Tel Aviv, 6423906, Israel

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Cuneo, 12100, Italy

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Milan, 20133, Italy

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Milan, 20141, Italy

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Rozzano, 20089, Italy

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Napoli, 80131, Italy

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Brescia, 25123, Italy

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Kashiwa, 277-8577, Japan

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Chūōku, 104-0045, Japan

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Ōsaka-sayama, 589-8511, Japan

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Sendai, 980-8574, Japan

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Miki, 761-0793, Japan

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Nagoya, 464-8681, Japan

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Kaunas, 50161, Lithuania

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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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Skorzewo, 60-185, Poland

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Gdansk, 80-214, Poland

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Krakow, 31-826, Poland

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Warsaw, 02-781, Poland

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Gliwice, 44-102, Poland

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Goyang-si, 10408, South Korea

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Seoul, 03080, South Korea

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Busan, 48108, South Korea

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Suwon, 16499, South Korea

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Hwasun, 58128, South Korea

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Soeul, 03722, South Korea

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Seoul, 05505, South Korea

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Seoul, 06351, South Korea

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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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Valencia, 46009, Spain

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Madrid, 28040, Spain

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Barcelona, 08035, Spain

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Sankt Gallen, 9007, Switzerland

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Kaohsiung City, 80756, Taiwan

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Tainan, 70428, Taiwan

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Taipei, 112, Taiwan

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Taipei, 100, 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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Kaohsiung City, 833, Taiwan

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London, EC1A 7BE, United Kingdom

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London, E20 1JQ, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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Cardiff, CF14 2TL, United Kingdom

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London, SW3 6JJ, United Kingdom

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Sutton, SM2 5PT, United Kingdom

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Liverpool, L7 8YA, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Cambridge, CB2 0QQ, United Kingdom

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Middlesex, HA6 2RN, United Kingdom

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London, SE1 9RT, United Kingdom

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Mobile, Alabama, 36608, United States

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Prescott, Arizona, 86301, United States

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Scottsdale, Arizona, 85054, United States

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Sacramento, California, 95817, United States

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Orange, California, 92868, United States

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La Jolla, California, 92037, United States

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Palo Alto, California, 94304, United States

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San Francisco, California, 94158, United States

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Duarte, California, 91010, United States

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Lone Tree, Colorado, 80124, United States

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

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Fort Myers, Florida, 33501, United States

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Jacksonville, Florida, 32224, United States

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Temple Terrace, Florida, 33612, United States

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Orlando, Florida, 32827, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60637, United States

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Indianapolis, Indiana, 46202, United States

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Louisville, Kentucky, 40202, United States

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New Orleans, Louisiana, 70121, United States

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Baton Rouge, Louisiana, 70809, United States

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Columbia, Maryland, 21044, United States

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Boston, Massachusetts, 02215, United States

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Ann Arbor, Michigan, 48109, United States

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Detroit, Michigan, 48201, United States

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Rochester, Minnesota, 55905, United States

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Maple Grove, Minnesota, 55369, United States

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St Louis, Missouri, 63110, 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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New York, New York, 10029, United States

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Durham, North Carolina, 27710, United States

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Chapel Hill, North Carolina, 27514, United States

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Cincinnati, Ohio, 45219, United States

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Columbus, Ohio, 43210, United States

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Cleveland, Ohio, 44195, United States

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Portland, Oregon, 97213, United States

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Bensalem, Pennsylvania, 19020, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19114, United States

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Charleston, South Carolina, 29425, 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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Nashville, Tennessee, 37232, United States

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El Paso, Texas, 79915, United States

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Houston, Texas, 77030, United States

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Denison, Texas, 75020, United States

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Houston, Texas, 77030, United States

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Pearland, Texas, 77584, 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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Winchester, Virginia, 22601, United States

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Charlottesville, Virginia, 22908, United States

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Seattle, Washington, 98109, United States

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Spokane, Washington, 99202, United States

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Site 37

Buenos Aires, C1125ABD, Argentina

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Site 80

Buenos Aires, C1426ANZ, Argentina

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Site 129

Brussels, 1070, Belgium

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A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator's Choice Monotherapy Treatment in Previously Treated Patients With Incurable, Metastatic/Recurrent 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 (180)

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