Oral TrkA Inhibitor VMD-928 for Treatment of Advanced Adult Solid Tumors or Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 25, 2022
  • participants needed
    54
  • sponsor
    VM Oncology, LLC
Updated on 25 March 2021
cancer
myeloid leukemia
lymphoma
carcinoma
squamous cell carcinoma
leukemia
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 Malignant neoplasm of prostate, Pancreatic Cancer, Cervical Cancer, Adenocarcinoma, Ovarian disorder, Adenoid Cystic Carcinoma, Disorders of cervix NOS, Uterine Cancer, Lymphoma, Prostatic disorder, Ovarian Cancer, Acute myeloid leukemia, Esophageal Diseases, Esophageal Cancer, melanoma, skin cancer, HEPATIC NEOPLASM, Lymphoproliferative Disorder, Lymphoma, Mesothelioma, HEPATOCELLULAR CARCINOMA, Gastropathy, Gastric Cancer, Mesothelioma, head and neck cancer, Stomach Discomfort, Metastatic Melanoma, Prostate Disorders, Non-Hodgkin's Lymphoma, Prostate Cancer, Early, Recurrent, Acute Myelogenous Leukemia (AML), Ovarian Function, Solid Tumor, Esophageal Carcinoma, Squamous Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Malignant Mesothelioma, Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, Gastric Carcinoma, Recurrent Ovarian Cancer, Islet Ce417ll Cancer, Prostate Cancer, Esophageal Disorders, Malignant Melanoma, Liver Cancer, Malignant Adenoma, Stomach Cancer, Lymphoproliferative disorders, Thymic Carcinoma and Thymoma, Squamous Cell Carcinoma of Lung, cervical carcinoma, prostate carcinoma, non-hodgkin's lymphoma (nhl), ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, gastric cancers, esophagus cancer, oesophageal cancer, cervical cancer, uterine, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix, ovarian tumors, prostate cancers, liver cell carcinoma, acute myelogenous leukemia, anll, acute myeloblastic leukemia, cancer of the esophagus, oesophageal carcinoma
Treatment VMD-928 300-mg Capsules, VMD-928 300 mg Tablets or 100 mg Capsules
Clinical Study IdentifierNCT03556228
SponsorVM Oncology, LLC
Last Modified on25 March 2021

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