Oral TrkA Inhibitor VMD-928 for Treatment of Advanced Adult Solid Tumors or Lymphoma
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ClinicalTrials.gov Identifier: NCT03556228 |
Recruitment Status :
Recruiting
First Posted : June 14, 2018
Last Update Posted : December 8, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thymic Carcinoma and Thymoma Mesothelioma Head and Neck Squamous Cell Carcinoma Ovarian Cancer Hepatocellular Carcinoma Squamous Cell Carcinoma of Lung Esophageal Cancer Adenoid Cystic Carcinoma Prostate Cancer Cervical Cancer Gastric Cancer Melanoma Acute Myeloid Leukemia Non Hodgkin Lymphoma | Drug: VMD-928 300 mg Tablets or 100 mg Capsules | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 54 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Intervention Model Description: |
|
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 in Subjects With Solid Tumors or Lymphoma |
Actual Study Start Date : | June 8, 2018 |
Estimated Primary Completion Date : | June 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: VMD-928 300 mg Tablet or 100 mg Capsule |
Drug: VMD-928 300 mg Tablets or 100 mg Capsules
Taken orally once daily |
- Number and severity of treatment-emergent AEs [ Time Frame: Within two months of the first VMD-928 dose for each patient ]
- Area under the plasma concentration versus time curve (AUC) of VMD-928. [ Time Frame: Two to three months after starting treatment for each patient [Estimated] ]
- Peak plasma concentration (Cmax) of VMD-928. [ Time Frame: Two to three months after starting treatment for each patient [Estimated] ]
- Incidence of Dose Limiting Toxicities. [ Time Frame: Within two months of the first VMD-928 dose for each patient ]
- Analgesic response as defined by the Brief Pain Inventory (BPI). [ Time Frame: Within two months after starting treatment for each patient [Estimated] ]
- Change in p-TrkA protein expression. [ Time Frame: Pre-dose and within two months after starting treatment for each patient [Estimated] ]
- Correlation between clinical antitumor and AUC. [ Time Frame: Six to eight months after starting treatment for each patient [Estimated] ]
- Correlation between clinical antitumor and p-TrkA inhibition. [ Time Frame: Six to eight months after starting treatment for each patient [Estimated] ]
- Correlation between analgesic response and p-TrkA inhibition. [ Time Frame: Six to eight months after starting treatment for each patient [Estimated] ]
- Correlation between analgesic response and AUC. [ Time Frame: Six to eight months after starting treatment for each patient [Estimated] ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Part-1 Dose Escalation [Key Inclusion]:
- Histologically or cytologically confirmed diagnosis of solid tumor malignancy or lymphoma that is not responsive to standard therapies, are unfit for standard chemotherapy or for which there is no approved or curative therapy.
- ECOG score of 0 or 1.
- Able to swallow and retain oral medication.
- Adequate organ system function.
Parts 2-4 Cohort Expansion Only [Key Inclusion]:
- Part 1 inclusion criteria.
-
Subjects must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose, that is sufficient for IHC analysis of TrkA expression, AND have a tumor or tumor type in one of the following categories:
(i). Tumors showing a response or stable disease after at least 2 cycles of VMD-928 during Part 1;
(ii). Tumor types associated with high TrkA protein overexpression, i.e.:
- Thymic carcinoma and thymoma
- Mesothelioma
- Head and neck squamous cell carcinoma (HNSCC)
- Ovarian cancer (especially serous)
- Hepatocellular carcinoma
- Squamous cell carcinoma of lung (squamous NSCLC)
- Esophageal cancer
- Adenoid cystic carcinoma
- Prostate cancer
- Cervical cancer
- Gastric cancer
- Melanoma
- Acute myeloid leukemia
- Pancreatic carcinoma
- Non-Hodgkins' lymphoma
(iii). Tumors with documented NTRK1 gene fusions or amplifications, or TrkA protein overexpression, or a tumor which has progressed due to NTRK1 mutation after treatment of a pan-Trk inhibitor (e.g. larotrectinib or entrectinib)
Part 3 Pharmacodynamic Activity only (Eligible subjects in Part 2 may enroll in Part 3):
- Part-2 inclusion criteria.
- Tumor with readily accessible lesion that is amenable to biopsy and consent to pre-and post-dose biopsy.
Part 4 Exploratory Comparative PK of Tablet vs. Capsule Formulations only (Eligible subjects in Part 2 or 3 will be encouraged to enroll in Part 4)
Key Exclusion Criteria (Parts 1-4):
- Received chemotherapy having delayed toxicity within the last 21 days (six weeks for prior nitrosourea or mitomycin C).
- Received anticancer therapy with radiation, immunotherapy, a biologic, surgery and/or tumor embolization within the past 2 weeks.
- Received an investigational anti-cancer drug within 21 days or 5 half-lives of the investigational agent prior, whichever is longer, to the first dose of VMD-928.
- Unresolved toxicity from previous anti-cancer therapy ≥ CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Investigator and Sponsor.
- Negative result on TrkA-specific or pan-Trk IHC assay (Parts 2-4 only).
- Known active infections including HIV disease.
- Currently pregnant, nursing, or planning to become pregnant during the course of the study.
- QTcF interval ≥ 480 msec.
- Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
- Acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.
- Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the patient's safety or interfere with assessment of the drug.
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Psychological, familial, sociological, geographical or other concurrent conditions that would interfere with safety evaluation, limit the subject's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Subjects with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.
Key Exclusion Criteria (For Parts 1 and 4 only):
-
Any current medical condition that would alter the absorption, distribution, metabolism or excretion of VMD-928 including but not limited to:
- Severe uncontrolled nausea or vomiting
- Severe uncontrolled diarrhea
- With a history of short bowel syndrome
- Clinically diagnosed malabsorption secondary to bowel resection

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556228
Contact: Jay Wu, PhD | 510-661-6770 ext 101 | OM@VMOncology.com | |
Contact: Liz Gaynor; Cameron Wright | 602-358-8344; 602-358-8341 | egaynor@td2inc.com; cwright@td2inc.com |
United States, California | |
City of Hope National Medical Center | Recruiting |
Duarte, California, United States, 91010 | |
Contact: Aruna V Parikh, M.B.B.S. CCRC 626-218-3419 ext 83419 arparikh@coh.org | |
Contact: Nikeeta Prajapati, RN, BSN 626-218-0029 ext 80029 | |
Principal Investigator: Vincent Chung, MD | |
United States, New Jersey | |
Atlantic Health System, Morristown Medical Center | Recruiting |
Morristown, New Jersey, United States, 07962 | |
Contact: Leah Zitelli 973-971-6312 Leah.Cappadona@atlantichealth.org | |
Contact: Rosemary Stefiniw 973-971-5990 Rosemary.Stefiniw@atlantichealth.org | |
Principal Investigator: Angela Alistar, MD | |
United States, New York | |
Weill-Cornell Medicine, Cornell University | Not yet recruiting |
New York, New York, United States, 10065 | |
Contact: Anita Ou, MPH CCRP | |
Principal Investigator: Giuseppe Giaccone, MD PhD | |
United States, Texas | |
The University of Texas MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: David S Hong 713-563-5844 dshong@mdanderson.org | |
Principal Investigator: David S Hong, MD | |
United States, Wisconsin | |
Medical College of Wisconsin | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Mike Jacklin 414-805-8839 mjacklin@mcw.edu | |
Contact: Holly Lemke 414-805-0261 hlemke@mcw.edu | |
Principal Investigator: Sailaja Kamaraju, MD |
Study Director: | Peg Fletcher, MD PhD | MedAssessment |
Responsible Party: | VM Oncology, LLC |
ClinicalTrials.gov Identifier: | NCT03556228 |
Other Study ID Numbers: |
VMO-01C |
First Posted: | June 14, 2018 Key Record Dates |
Last Update Posted: | December 8, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
TrkA NTRK1 Thymic carcinoma and thymoma Mesothelioma Head and Neck Squamous Cell Carcinoma Ovarian Cancer Hepatocellular Carcinoma Squamous Cell Carcinoma of Lung (squamous NSCLC) |
Esophageal Cancer Adenoid Cystic Carcinoma Prostate Cancer Cervical Cancer Gastric Cancer Melanoma Acute Myeloid Leukemia Non Hodgkin Lymphoma |
Lymphoma Carcinoma Prostatic Neoplasms Melanoma Carcinoma, Squamous Cell Leukemia, Myeloid, Acute Ovarian Neoplasms Lymphoma, Non-Hodgkin Carcinoma, Hepatocellular Stomach Neoplasms Uterine Cervical Neoplasms Esophageal Neoplasms Mesothelioma Squamous Cell Carcinoma of Head and Neck Carcinoma, Adenoid Cystic |
Thymoma Lung Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Glandular and Epithelial Leukemia Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Prostatic Diseases Leukemia, Myeloid |