A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients

JRCT ID: jRCT2031240485

Registered date:14/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Head and neck squamous cell carcinoma (HNSCC)
• Date of first enrollment: 29/11/2024
• Target sample size: 50
• Countries of recruitment: Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,Greece,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Study participants will be randomly assigned to a study group to receive either petosemtamab or one of the approved drugs (cetuximab, methotrexate, or docetaxel) in this study.

petosemtamab monotherapy treatment:
Petosemtamab is administered intravenously once every 2 weeks at the prescribed dose.

investigators choice monotherapy treatment:
One of the approved drugs (cetuximab, methotrexate, or docetaxel) is administrated once a week at a prescribed dose.

Outcome(s)

• Primary Outcome: To compare antitumor activity in ORR per Response Evaluation Criteria in Solid Tumor (RECIST) Guidelines version (v) 1.1 as assessed by blinded independent central review (BICR) and OS in patients treated with petosemtamab monotherapy vs investigators choice monotherapy.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Signed ICF before initiation of any study procedures.
- Age 18 years or more 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 or more, as per investigator
- Adequate organ function (as per protocol)

Exclude 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 over 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, potentially pregnant or breastfeeding patients and patients who are planning to become pregnant
- Patient has a primary tumor site of nasopharynx (any histology).

Related Information

• Primary Sponsor: Yao David
• Secondary ID(s): NCT06496178