Squamous Cell Carcinoma of Head and NeckEarly Phase 1NCT04188665
Using MASL to Combat Oral Cancer
A Early Phase 1 study testing MASL in people with Squamous Cell Carcinoma of Head and Neck, run by Rowan University at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- MASL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Jan 2021to 15 May 2025
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
New Jersey Medical School
Newark, New Jersey, 07103
Rutgers School for Dental Medicine
Newark, New Jersey, 07103
University Hospital
Newark, New Jersey, 07103
Rowan University
Stratford, New Jersey, 08084
About this study
Official title: 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
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
- Being tested
- MASL, Placebo
- Keywords
- maackia amurensis, podoplanin, pdpn, lectin, oral squamous cell carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MASLDrug
Also called Maackia amurensis seed lectin
Patients treated with MASL lozenge
PlaceboOther
Patients treated with placebo lozenge
| Study group | Role | What they receive |
|---|---|---|
| MASL treated | Experimental | Patients treated with lozenge containing MASL Receives: Drug: MASL |
| Placebo treated | Placebo comparator | Patients treated with lozenge without MASL Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day.
Secondary outcomes (1)
Post-treatment OSCC Morphology and PDPN Expression
Evaluate and compare the PDPN expression and morphology of cells from included in resected oral lesions from patients treated with the experimental compound MASL or placebo. We will measure if MASL treatment decreases PDPN expression and normalizes morphology of OSCC cells on a defined scale of pathological examination by immunohistochemistry.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start29 Jan 2021
- Primary completion31 Dec 2024
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers University
- Responsible party
- Sponsor
- Investigators
- Gary S Goldberg, Principal investigator, Rowan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188665
- Sponsor's protocol ID
- Pro2019000548
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2019
- Last updated
- 20 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40681758
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04188665
- Acronym / sponsor ID
- Pro2019000548
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- maackia amurensis, podoplanin, pdpn, lectin, oral squamous cell carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Collaborators
- Rutgers University
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Posted 20 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MASL treated | Experimental | Drug: MASLPatients treated with lozenge containing MASL |
| Placebo treated | Placebo comparator | Other: PlaceboPatients treated with lozenge without MASL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MASLAlso: Maackia amurensis seed lectinPatients treated with MASL lozenge | Drug | MASL treated |
| PlaceboPatients treated with placebo lozenge | Other | Placebo treated |
Primary outcome
Pre-treatment OSCC Morphology and PDPN Expression
Time frame: 1 day.
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 secondary outcome
Post-treatment OSCC Morphology and PDPN Expression
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40681758Yin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary S Goldberg principal investigator
Rowan University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MASL in people with Squamous Cell Carcinoma of Head and Neck, run by Rowan University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-treatment OSCC Morphology and PDPN Expression (time frame: 1 day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04188665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.