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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03556228
Other study ID # VMO-01C
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 8, 2018
Est. completion date June 2026

Study information

Verified date May 2024
Source VM Oncology, LLC
Contact Jay Wu, PhD
Phone 510-270-2790, 510-661-6770
Email OM@VMOncology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, open-label, Phase 1 study of orally administered VMD-928 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


Description:

This is an open-label, Phase I, FTIH, multiple-dose, dose-escalation and cohort expansion multi-center study conducted in three parts to identify a safe and pharmacologically active dose and regimen for VMD-928 monotherapy, which can be implemented in Phase 2 studies (the RP2D). The regimen will be identified using an adaptive design, multiple-ascending dose study in cancer patients. To conserve patients in the lower dose cohorts, dose escalation will begin with an accelerated titration scheme. A second part of the study will assess antitumor activity at the RP2D. The third part of the study will collect tumor samples before and after treatment to assess biological activity.


Recruitment information / eligibility

Status Recruiting
Enrollment 74
Est. completion date June 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma that is not responsive to standard therapies or had progressed following standard therapy and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible. - ECOG score of 0 or 1. - Able to swallow and retain oral medication. - Adequate organ system function. - 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. - Subjects must have a tumor: (i). with TrkA protein overexpression in the validated TrkA IHC assay, OR (ii). with documented NTRK1 gene fusion, or a tumor which has progressed due to NTRK1 mutation after treatment of a pan-Trk inhibitor (e.g. larotrectinib or entrectinib) - Adequate organ system function as defined as follows: 1. Absolute neutrophil count =1.5x10^9/L 2. Hemoglobin =9g/dL 3. Platelets =100x10^9/L 4. PT/INR, PTT =1.5xULN 5. Total bilirubin =1.5x ULN 6. AST, ALT =2.5xULN 7. Creatinine =1.2xULN for age, weight 8. Calculated creatinine clearance or 24h urine creatinine clearance =60mL/min Key Exclusion Criteria: 1. Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C). 2. Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and/or tumor embolization within the past 2 weeks. 3. Received an investigational anticancer drug within 14 days or 5 half-lives of the investigational agent, whichever is longer, prior to the first dose of VMD-928. Any exceptions to the above must be approved by the Sponsor Medical Monitor. 4. Unresolved toxicity from previous anticancer therapy > CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Sponsor Medical Monitor and the Investigator. 5. Negative result on TrkA immunohistochemistry (IHC) assay. 6. Known active infections including HIV disease. 7. Patients with a history of chronic viral hepatitis (HBV/HCV) or a history of cirrhotic liver secondary to any etiology (i.e. alcoholism, non-alcoholic steatohepatitis). 8. Currently pregnant, nursing, or planning to become pregnant during the course of the study. 9. QTcF interval = 480 msec. 10. Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. 11. Acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks. 12. Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the patient's safety or interfere with assessment of the drug. 13. Psychological, familial, sociological, geographical, or other concurrent conditions that would interfere with safety evaluation, limit the patient's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Patients with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded. 14. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drug, or excipients

Study Design


Related Conditions & MeSH terms

  • Adenoid Cystic Carcinoma
  • Bladder Cancer
  • Breast Cancer
  • Carcinoma
  • Carcinoma, Adenoid Cystic
  • Carcinoma, Non-Small-Cell Lung
  • Cervical Cancer
  • Esophageal Cancer
  • Head and Neck Carcinoma
  • Lung Cancer
  • Lung Neoplasms
  • Mesothelioma
  • Mesothelioma, Malignant
  • Non-Small Cell Lung Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Sarcoma
  • Thymic Carcinoma
  • Thymoma
  • Urinary Bladder Neoplasms
  • Uterine Cancer
  • Uterine Cervical Neoplasms
  • Uterine Neoplasms

Intervention

Drug:
VMD-928 300 mg Tablet (ongoing); 100 mg Capsule (complete)
Taken orally once daily

Locations

Country Name City State
Puerto Rico PanOncology Trials, Hospital Oncologico - Puerto Rico Medical Center, Río Piedras San Juan
United States Gabrail Cancer Center Research Canton Ohio
United States Erlanger Health System (Hospital); University of Tennessee College of Medicine, Chattanooga Chattanooga Tennessee
United States City of Hope National Medical Center Duarte California
United States Englewood Hospital and Medical Center Englewood New Jersey
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Cayuga Medical Center Ithaca New York
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Atlantic Health System, Morristown Medical Center Morristown New Jersey
United States Weill Cornell Medicine, Cornell University New York New York
United States Memorial Cancer Institute at Memorial Healthcare Systems Pembroke Pines Florida

Sponsors (1)

Lead Sponsor Collaborator
VM Oncology, LLC

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number and severity of treatment-emergent AEs Within 2 cycles (each cycle is 28 days)
Secondary Area under the plasma concentration versus time curve (AUC) of VMD-928. On Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Secondary Peak plasma concentration (Cmax) of VMD-928. On Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Secondary Incidence of Dose Limiting Toxicities. During the Cycle 1 (each cycle is 28 days)
Secondary Analgesic response as defined by the Brief Pain Inventory (BPI). On Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Secondary Change in TrkA protein expression. Pre-dose and at the end of Cycle 2 (each cycle is 28 days)
Secondary Correlation between clinical antitumor and AUC. Up to the end of the Cycle 2 (each cycle is 28 days)
Secondary Correlation between clinical antitumor and TrkA protein expression. Up to the end of the Cycle 2 (each cycle is 28 days)
Secondary Correlation between analgesic response and TrkA protein expression. Up to the end of the Cycle 2 (each cycle is 28 days)
Secondary Correlation between analgesic response and AUC. Up to the end of the Cycle 2 (each cycle is 28 days)
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