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

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

Secondary Objectives:

To evaluate antitumor activity in ORR per
RECIST v1.1 as assessed by investigator review
To evaluate antitumor activity in DOR per
RECIST v1.1 as assessed by BICR and
investigator review
To evaluate antitumor activity in TTR per
RECIST v1.1 as assessed by BICR and
investigator review
To evaluate antitumor activity in PFS per
RECIST v1.1 as assessed by BICR and by
investigator review
To evaluate antitumor activity in CBR per
RECIST v1.1 as assessed by BICR and by
investigator review
To evaluate safety and tolerability of
petosemtamab monotherapy
To evaluate patient health-related quality of
life (HRQL) using the European Organisation
for Research and Treatment of Cancer (EORTC)
validated Quality of Life of Cancer Patients
Questionnaire (QLQ-C30)
To evaluate patient HRQL using the updated
EORTC validated Quality of Life of Head and
Neck Cancer Patients Questionnaire (QLQH&N43)
To characterize the PK of petosemtamab
To characterize the population PK of
petosemtamab
To characterize the immunogenicity of
petosemtamab

Eligibility

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

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices