Clinical trial · Interventional
Using MASL to Combat Oral Cancer
Using Maackia Amurensis Seed Lectin to Target the Podoplanin Receptor as a Functionally Relevant Biomarker to Inhibit the Growth of Oral Squamous Cell Carcinoma and Precancerous Lesions
NCT04188665CI-TRIAL-00106098completedEarly Phase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MASL | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MASL treated
- description
- Patients treated with lozenge containing MASL
- interventionNames
- Drug: MASL
- type
- PLACEBO_COMPARATOR
- label
- Placebo treated
- description
- Patients treated with lozenge without MASL
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Pre-treatment OSCC Morphology and PDPN Expression
- timeFrame
- 1 day.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males and females of at least 18 years of age who are able to give consent. 2. Smokers and non-smokers. 3. 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. 4. 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. 5. patients will be considered for inclusion at any stage of disease progression. 6. Patients will be considered for inclusion if a subsequent biopsy or surgical resection are planned as part of their best care treatment. 7. Patients will have an Eastern Cooperative Oncology Group performance status of 0 or 1. 8. Patients will display normal organ function as evidenced by standard laboratory blood tests including liver enzymes and creatine. 9. Patients will not present evidence of comorbidities including ongoing or active infection, unstable illness, or medical conditions. Exclusion Criteria: 1. Patients with cognitive impairments and cannot consent for themselves. 2. Patients with language/hearing impairments. 3. Use of a topical steroid product within the last 2 weeks. 4. Pregnant women (to avoid any potential risk to the fetus) to be confirmed by standard blood or urine tests according to best care practice. 5. Patients who are breastfeeding. 6. Abstinence or use of adequate contraception will be required for women of childbearing potential and men of reproductive potential.
References
Publications (1)
- RESULTYin AC, Holdcraft CJ, Helmig TJ, Brace EJ, Suster DI, Shienbaum AJ, Roden D, Kalyoussef E, Mir G, Capitle E, Baredes S, Shanti RM, Kaneko MK, Kato Y, Kobayashi H, Furusawa A, Fatahzadeh M, Goldberg GS. Effects of Maackia amurensis seed lectin (MASL) on OSCC cell morphology, PDPN expression, growth, and motility in a phase 1 clinical trial. J Cancer Res Clin Oncol. 2025 Jul 19;151(7):218. doi: 10.1007/s00432-025-06265-z. PMID 40681758