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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510322-32-00

Acronym

MCLA-158-CL02

Enrollment

273

Registered

2024-08-27

Start date

2025-01-27

Completion date

Unknown

Last updated

2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic/recurrent head and neck squamous cell carcinoma, patients with incurable

Brief summary

Objective response rate (ORR) per RECIST v1.1 as assessed by BICR., Overall survival (OS)

Detailed description

1. Progression Free Survival PFS per RECIST v1.1 as assessed by BICR, 2. DOR per RECIST v1.1 as assessed by BICR, 3. OOR per RECIST v1.1 as assessed by investigator review, 4. PFS per RECIST v1.1 as assessed by investigator review, 5. DOR per RECIST v1.1 as assessed by investigator review, 6. TTR per RECIST v1.1 as assessed by BICR and by Investigator review, 7. CBR per RECIST v1.1 as assessed by BICR and by Investigator review, 8. Assess number of patients experiencing TEAEs, 9. Number of patients experiencing serious TEAEs, 10. Number of patients who discontinued study treatment due to TEAEs, 11. Number of patients who had dose modifications due to TEAEs

Interventions

DRUGDocetaxel EVER Valinject 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGMethotrexate 25 mg/ml solution for injection

DRUGErbitux 5 mg/mL solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) per RECIST v1.1 as assessed by BICR., Overall survival (OS)	—

Secondary

Measure	Time frame
1. Progression Free Survival PFS per RECIST v1.1 as assessed by BICR, 2. DOR per RECIST v1.1 as assessed by BICR, 3. OOR per RECIST v1.1 as assessed by investigator review, 4. PFS per RECIST v1.1 as assessed by investigator review, 5. DOR per RECIST v1.1 as assessed by investigator review, 6. TTR per RECIST v1.1 as assessed by BICR and by Investigator review, 7. CBR per RECIST v1.1 as assessed by BICR and by Investigator review, 8. Assess number of patients experiencing TEAEs, 9. Number of patients experiencing serious TEAEs, 10. Number of patients who discontinued study treatment due to TEAEs, 11. Number of patients who had dose modifications due to TEAEs	—

Measure

Time frame

—

Countries

Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026