NCT03556228 is a Phase 1/Phase 2 clinical trial of VMD-928 100 mg Tablet in Head and Neck Carcinoma, sponsored by VM Oncology, LLC.

Who is sponsoring NCT03556228?

NCT03556228 is sponsored by VM Oncology, LLC.

What drugs are being tested in NCT03556228?

Interventions in NCT03556228: VMD-928 100 mg Tablet, VMD-928 Tablet and Pembrolizumab (200 mg).

What condition does NCT03556228 study?

NCT03556228 studies Head and Neck Carcinoma, Adenoid Cystic Carcinoma, Lung Cancer, Non-Small Cell Lung Cancer, Pancreatic Cancer, Mesothelioma, Esophageal Cancer, Any Solid Tumors Progressed After a Prior Immunotherapy, Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma HNSCC, Salivary Gland Carcinomas, Head and Neck Cancers - Salivary Gland, Head and Neck Cancers - Nasopharyngeal, Head and Neck Cancers - Throat, Small Cell Lung Cancer ( SCLC ), Lung Cancer (Locally Advanced or Metastatic), Head and Neck Cancers - Tonsils, Head and Neck Cancers Hypopharynx, Head and Neck Cancers Larynx, Head and Neck Cancers Lip, Head and Neck Cancers Nasopharynx, Head and Neck Cancers Oral Cavity, Head and Neck Cancers, Head and Neck Cancers Oropharynx, Head and Neck Cancers Trachea.

Is NCT03556228 still recruiting?

NCT03556228 is currently recruiting now. Last updated 4 December 2025.

Last reviewed 2025-12-04 · How we verify

NCT03556228

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 as Monotherapy and in Combination With Pembrolizumab in Subjects With Solid Tumors or Lymphoma

Recruiting now Phase 1/Phase 2 Last updated 4 December 2025

What this trial tests

Phase 1/Phase 2 trial testing VMD-928 100 mg Tablet in Head and Neck Carcinoma in 242 participants. Currently enrolling.

Timeline

8 June 2018

Primary endpoint
1 December 2027

1 June 2028

Quick facts

Lead sponsor	VM Oncology, LLC
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	242
Start date	8 June 2018
Primary completion	1 December 2027
Estimated completion	1 June 2028
Sites	15 locations across United States, Puerto Rico

Drugs / interventions tested

VMD-928 100 mg Tablet — full drug profile →
VMD-928 Tablet and Pembrolizumab (200 mg) — full drug profile →

Conditions studied

Head and Neck Carcinoma — all drugs for Head and Neck Carcinoma →
Adenoid Cystic Carcinoma — all drugs for Adenoid Cystic Carcinoma →
Lung Cancer — all drugs for Lung Cancer →
Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

VM Oncology, LLC — full company profile →

Who can join

Adults 18 to 80, any sex, with Head and Neck Carcinoma or Adenoid Cystic Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number and severity of treatment-emergent Adverse Events (Phase 1)
Time frame: First cycle (21 days per cycle)
TEAE
To determine the recommended Phase 2 dose for VMD-928 (Phase 1)
Time frame: First cycle (21 days per cycle)
RP2D of monotherapy
To determine the RP2D of VMD-928 in combination with pembrolizumab (Phase 1)
Time frame: First cycle (21 days per cycle)
RP2D of combination therapy
Antitumor activity of VMD-928 in subjects with TrkA-driven tumors (Phase 2)
Time frame: Up to 18 months
Antitumor efficacy signal for monotherapy
Antitumor activity of VMD-928 in combination with pembrolizumab in subjects with TrkA-driven tumors (Phase 2)
Time frame: Up to 18 months
Antitumor efficacy signal for combination therapy

Sponsor's own description

This is a multicenter, open-label, Phase 1/2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeted therapy in advanced non-small cell lung cancer: current advances and future trends.
Majeed U, Manochakian R, Zhao Y, Lou Y. · · 2021 · cited 193× · PMID 34238332 · DOI 10.1186/s13045-021-01121-2
Development of small-molecule tropomyosin receptor kinase (TRK) inhibitors for <i>NTRK</i> fusion cancers.
Jiang T, Wang G, Liu Y, Feng L, et al · · 2021 · cited 109× · PMID 33643817 · DOI 10.1016/j.apsb.2020.05.004
Nerves in the Tumor Microenvironment: Origin and Effects.
Wang W, Li L, Chen N, Niu C, et al · · 2020 · cited 76× · PMID 33392191 · DOI 10.3389/fcell.2020.601738
KRAS wild-type pancreatic ductal adenocarcinoma: molecular pathology and therapeutic opportunities.
Luchini C, Paolino G, Mattiolo P, Piredda ML, et al · · 2020 · cited 75× · PMID 33115526 · DOI 10.1186/s13046-020-01732-6
NTRK Fusion in Non-Small Cell Lung Cancer: Diagnosis, Therapy, and TRK Inhibitor Resistance.
Liu F, Wei Y, Zhang H, Jiang J, et al · · 2022 · cited 61× · PMID 35372074 · DOI 10.3389/fonc.2022.864666
Systemic therapies for salivary gland adenoid cystic carcinoma.
Sahara S, Herzog AE, Nör JE. · · 2021 · cited 50× · PMID 34659878
Perineural Invasion in Pancreatic Ductal Adenocarcinoma: From Molecules towards Drugs of Clinical Relevance.
Selvaggi F, Melchiorre E, Casari I, Cinalli S, et al · · 2022 · cited 43× · PMID 36497277 · DOI 10.3390/cancers14235793
Angiogenesis in Gynecological Cancers: Role of Neurotrophins.
Garrido MP, Torres I, Vega M, Romero C. · · 2019 · cited 38× · PMID 31608227 · DOI 10.3389/fonc.2019.00913

Verify or expand the search:

Other recruiting trials for Head and Neck Carcinoma

Currently open trials in the same condition.

NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT07227792 — Tongue-out Radiation Therapy (TORT) for the Mitigation of Radiotherapy-related Toxicities in Patients With Head and Neck · NA · recruiting
NCT06896695 — A Financial Intervention (Financial Compass) to Identify and Address Financial Hardship Among Head and Neck Cancer Patie · NA · recruiting
NCT07118176 — Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers · Phase 1 · recruiting
NCT06985784 — Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03556228 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VM Oncology, LLC
Last refreshed: 4 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03556228.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing