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 : March 15, 2021
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Tracking Information | |||||||||
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First Submitted Date ICMJE | April 29, 2018 | ||||||||
First Posted Date ICMJE | June 14, 2018 | ||||||||
Last Update Posted Date | March 15, 2021 | ||||||||
Actual Study Start Date ICMJE | June 8, 2018 | ||||||||
Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Number and severity of treatment-emergent AEs [ Time Frame: Within two months of the first VMD-928 dose for each patient ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Oral TrkA Inhibitor VMD-928 for Treatment of Advanced Adult Solid Tumors or Lymphoma | ||||||||
Official Title ICMJE | 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 | ||||||||
Brief 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 | ||||||||
Detailed 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. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Intervention Model Description:
Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: VMD-928 300 mg Tablets or 100 mg Capsules
Taken orally once daily
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Study Arms ICMJE | Experimental: VMD-928 300 mg Tablet or 100 mg Capsule
Intervention: Drug: VMD-928 300 mg Tablets or 100 mg Capsules
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
54 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 2022 | ||||||||
Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Part-1 Dose Escalation [Key Inclusion]:
Parts 2-4 Cohort Expansion Only [Key Inclusion]:
(ii). Tumor types associated with high TrkA protein overexpression, i.e.:
(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 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):
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03556228 | ||||||||
Other Study ID Numbers ICMJE | VMO-01C | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | VM Oncology, LLC | ||||||||
Study Sponsor ICMJE | VM Oncology, LLC | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | VM Oncology, LLC | ||||||||
Verification Date | March 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |