Using MASL to Combat Oral Cancer

NCT04188665 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: Pro2019000548
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

maackia amurensis; podoplanin; pdpn; lectin; oral squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Pre-treatment OSCC Morphology and PDPN Expression

  Measure morphology and podoplanin (PDPN) expression by immunohistochemistry of cells included in initial biopsies of oral lesions in comparison to normal oral squamous epithelial cells (OSCCs). We selected patients with lesions that express robust levels of PDPN and notable dysplasia for inclusion in the study. Intensity was graded on a scale of 1 to 5 with 5 having the most dysplastic morphology and highest PDPN expression.

  1 day.

Secondary Outcomes (1)

• Post-treatment OSCC Morphology and PDPN Expression

  1 day

Study Arms (2)

MASL treated

EXPERIMENTAL

Patients treated with lozenge containing MASL

Drug: MASL

Placebo treated

PLACEBO COMPARATOR

Patients treated with lozenge without MASL

Other: Placebo

Interventions

MASL DRUG

Patients treated with MASL lozenge

Also known as: Maackia amurensis seed lectin

MASL treated

Placebo OTHER

Patients treated with placebo lozenge

Placebo treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rowan University: lead
• Rutgers University: collaborator

Study Sites (4)

New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Rutgers School for Dental Medicine

Newark, New Jersey, 07103, United States

Location

University Hospital

Newark, New Jersey, 07103, United States

Location

Rowan University

Stratford, New Jersey, 08084, United States

Location

Related Publications (1)

• Yin 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 RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Gary S. Goldberg
• Organization: Rowan University

gary.goldberg@rowan.edu

8565666718

Study Officials

• Gary S Goldberg

  Rowan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: December 6, 2019
• Study Start: January 29, 2021
• Primary Completion: December 31, 2024
• Study Completion: May 15, 2025
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2025-11

Locations

US (4)