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Clinical Trials List

Protocol NumberMCLA-158-CL02
NCT Number(ClinicalTrials.gov Identfier)NCT06496178
Active

2024-06-28 - 2028-03-31

Phase III

Recruiting8

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 Applicant

    MEDPACE TAIWAN LIMITED

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 林進清 Division of Radiation Therapy
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hui-Ching Wang Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HUAI-CHENG HUANG Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shau-Hsuan Li Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Muh-Hwa Yang Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王宏銘  Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Yu Lien Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shang-Yin Wu
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Head and Neck Squamous Cell Carcinoma

Objectives

The purpose of this trial is to compare the antitumor activity of petosemtamab and its impact on overall survival with standard cancer care.

Test Drug

Intravenous infusion

Active Ingredient

petosemtamab

Dosage Form

246

Dosage

100mg/5ml

Endpoints

• ORR assessed by BICR according to RECIST v1.1

• OS

Inclution 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

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).

The Estimated Number of Participants

  • Taiwan

    52 participants

  • Global

    500 participants

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