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
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- STATUS
- Recruiting
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- End date
- Jun 25, 2024
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- participants needed
- 74
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- sponsor
- VM Oncology, LLC
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 |
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| 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 Identifier | NCT03556228 |
| Sponsor | VM Oncology, LLC |
| Last Modified on | 25 October 2022 |
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