Early Phase 1 N=18 Randomized Double-blind Treatment

Using MASL to Combat Oral Cancer

Squamous Cell Carcinoma of Head and Neck

Bottom Line

View on ClinicalTrials.gov: NCT04188665 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Pre-treatment OSCC Morphology and PDPN Expression — 2.8; 3.4; 2.5 score on a scale from 1 to 5 — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: MASL (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Rowan University
Primary completion: Dec 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Pre-treatment OSCC Morphology and PDPN Expression	2.8; 3.4; 2.5	<0.05 sig
SECONDARY Post-treatment OSCC Morphology and PDPN Expression	4.1; 4.6; 3.7	—

Summary

This project will evaluate the expression of a receptor called podoplanin (PDPN) in cells from oral cancers and precancerous lesions. We will also determine how sensitive oral cancer cells are to a potential drug called Maackia amurensis seed lectin (MASL).

Eligibility Criteria

Inclusion Criteria

Males and females of at least 18 years of age who are able to give consent.
Smokers and non-smokers.
Persons with white or red spots and/or lesions suspected or found to be oral cancer or precancer on the inner surface of the mouth.
Oral lesions will be classified as OSCC or leukoplakia including, proliferative verrucous leukoplakia, conventional erythroplakia, suspect oral papillomas, or oral lichen planus. Only patients with such histologically confirmed diagnoses will be considered for inclusion.
patients will be considered for inclusion at any stage of disease progression.
Patients will be considered for inclusion if a subsequent biopsy or surgical resection are planned as part of their best care treatment.
Patients will have an Eastern Cooperative Oncology Group performance status of 0 or 1.
Patients will display normal organ function as evidenced by standard laboratory blood tests including liver enzymes and creatine.
Patients will not present evidence of comorbidities including ongoing or active infection, unstable illness, or medical conditions.

Exclusion Criteria

Patients with cognitive impairments and cannot consent for themselves.
Patients with language/hearing impairments.
Use of a topical steroid product within the last 2 weeks.
Pregnant women (to avoid any potential risk to the fetus) to be confirmed by standard blood or urine tests according to best care practice.
Patients who are breastfeeding.
Abstinence or use of adequate contraception will be required for women of childbearing potential and men of reproductive potential.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04188665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.