A Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 as Monotherapy and in Combination With Pembrolizumab in Subjects With Solid Tumors or Lymphoma

Who is this study for? Adult patients with Solid Tumors or Lymphoma that are unresponsive to standard therapies
What treatments are being studied? VMD-928
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a multicenter, open-label, Phase 1/2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• #. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma:

• Phase 1 Dose Escalation only: Subjects with

• (A) any advanced solid tumors of

⁃ Head and Neck Cancers (HNC) (of any types),

⁃ Esophageal cancer,

⁃ Lung cancers (of any types),

⁃ Mesothelioma,

⁃ Pancreatic cancers,

• Or,

• (B) any NTRK1 gene fusion positive (NTRK1+) solid tumors or lymphomas, that is relapsed, refractory or intolerant (R/R/I) to standard of care (SOC) 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.

• Phase 2 Monotherapy and Combination with Pembrolizumab only:

• Subjects must have

⁃ TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,

⁃ any NTRK1+ solid tumors or lymphoma\*, that is R/R/I to SOC.

• Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1.

• Able to swallow and retain oral medication.

• Subjects must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose.

• 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

Locations
United States
California
Providence Medical Foundation (site 209)
RECRUITING
Santa Rosa
Connecticut
Hartford Hospital (site 210)
RECRUITING
Hartford
Washington, D.c.
The George Washington University Cancer Center (site 212)
RECRUITING
Washington D.c.
Florida
Holy Cross Hospital (site 213)
RECRUITING
Fort Lauderdale
Memorial Cancer Institute at Memorial Healthcare Systems (site 132)
RECRUITING
Pembroke Pines
New Jersey
Englewood Hospital and Medical Center (site 202)
RECRUITING
Englewood
Summit Medical Group (site 205)
RECRUITING
Florham Park
Atlantic Health System, Morristown Medical Center (site 124)
RECRUITING
Morristown
New Mexico
Presbyterian Kaseman Hospital (site 208)
RECRUITING
Albuquerque
New York
Weill Cornell Medicine, Cornell University (site 126)
RECRUITING
New York
Ohio
Taylor Cancer Research Center (site 204)
RECRUITING
Maumee
Pennsylvania
Cancer Care Associates of York (site 206)
RECRUITING
York
Texas
The University of Texas MD Anderson Cancer Center (site 127)
RECRUITING
Houston
Utah
Utah Cancer Specialists (site 203)
RECRUITING
Salt Lake City
Other Locations
Puerto Rico
PanOncology Trials, Hospital Oncologico - Puerto Rico Medical Center, Río Piedras (site 200)
RECRUITING
San Juan
Contact Information
Primary
Jay Wu, PhD
OM@VMOncology.com
1-510-270-2790
Time Frame
Start Date: 2018-06-08
Estimated Completion Date: 2028-06
Participants
Target number of participants: 242
Treatments
Experimental: VMD-928 monotherapy
VMD-928 tablet monotherapy
Experimental: Combination Therapy
VMD-928 tablet in combination with fixed dose of pembrolizumab 200 mg once-very-21-day (per cycle)
Sponsors
Leads: VM Oncology, LLC

This content was sourced from clinicaltrials.gov