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

  • STATUS
    Recruiting
  • End date
    Jun 25, 2024
  • participants needed
    74
  • sponsor
    VM Oncology, LLC
Updated on 25 October 2022
cancer
myeloid leukemia
lymphoma
carcinoma
squamous cell carcinoma
cell transplantation
leukemia
neutrophil count
esophageal cancer
chemotherapy regimen
gastric cancer
cancer chemotherapy
solid tumour
solid tumor
ovarian cancer
squamous cell carcinoma of head and neck
esophagus cancer
prostate carcinoma
cancer of the ovary
thymic carcinoma
thymoma

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.

Details
Condition Any Solid Tumors, 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, Thymic Carcinoma and Thymoma, Progressor of Anti PD-1/PD-L1 Immunotherapy
Treatment VMD-928 300-mg Capsules, VMD-928 300 mg Tablets or 100 mg Capsules, VMD-928 300 mg Tablet (ongoing); 100 mg Capsule (complete)
Clinical Study IdentifierNCT03556228
SponsorVM Oncology, LLC
Last Modified on25 October 2022

Eligibility

Yes No Not Sure

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
Absolute neutrophil count ≥1.5x10^9/L
Hemoglobin ≥9g/dL
Platelets ≥100x10^9/L
PT/INR, PTT ≤1.5xULN
Total bilirubin ≤1.5x ULN
AST, ALT ≤2.5xULN
Creatinine ≤1.2xULN for age, weight
Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL/min

Exclusion Criteria

Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C)
Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and/or tumor embolization within the past 2 weeks
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
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
Negative result on TrkA immunohistochemistry (IHC) assay
Known active infections including HIV disease
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)
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
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
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drug, or excipients
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