Ovarian Cancer Clinical Trial

Selective TrkA Inhibitor VMD-928 to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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:

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

Key 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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

74

Study ID:

NCT03556228

Recruitment Status:

Recruiting

Sponsor:

VM Oncology, LLC

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There are 7 Locations for this study

See Locations Near You

City of Hope National Medical Center
Duarte California, 91010, United States More Info
Aruna V Parikh, MBBS CCRC
Contact
626-218-3419
[email protected]
Nikeeta Prajapati, RN, BSN
Contact
626-218-0029
Vincent Chung, MD
Principal Investigator
Atlantic Health System, Morristown Medical Center
Morristown New Jersey, 07962, United States More Info
Salome Geene, RN, BSN, OCN
Contact
973-971-6373
[email protected]
Leah Zitelli
Contact
973.971.6312
[email protected]
Angela Alistar, MD
Principal Investigator
Weill-Cornell Medicine, Cornell University
New York New York, 10065, United States More Info
Genevieve Durso, MS BS
Contact
[email protected]
Jessica Wilk
Contact
[email protected]
Barbara Ma, M.D., M.S.
Principal Investigator
Gabrail Cancer Center Research
Canton Ohio, 44718, United States More Info
Amanda Rich
Contact
330-492-3345
[email protected]
Carrie Smith
Contact
[email protected]
Nashat Y Gabrail, MD
Principal Investigator
Erlanger Health System (Hospital); University of Tennessee College of Medicine, Chattanooga
Chattanooga Tennessee, 37403, United States More Info
Deborah Dyer, RN
Contact
423-778-3903
[email protected]
Matthew Oliver, MD
Principal Investigator
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Helen Nemariam
Contact
713-745-0809
[email protected]
Ly M Nguyen
Contact
713-563-2169
[email protected]
David S Hong, MD
Principal Investigator
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Cassandra Kujawa, CHES
Contact
414-805-8839
[email protected]
Jaydah Gonzalez
Contact
[email protected]
Sailaja Kamaraju, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

74

Study ID:

NCT03556228

Recruitment Status:

Recruiting

Sponsor:


VM Oncology, LLC

How clear is this clinincal trial information?

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