VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
NCT ID: NCT03556228
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
242 participants
INTERVENTIONAL
2018-06-08
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
* Dose Escalation (Phase 1)
* Cohort Expansion with RP2D (Phase 2)
TREATMENT
NONE
Study Groups
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VMD-928 monotherapy
VMD-928 tablet monotherapy
VMD-928 100 mg Tablet
Taken orally once daily for 21 days per 21-day cycle
Combination Therapy
VMD-928 tablet in combination with fixed dose of pembrolizumab 200 mg once-very-21-day (per cycle)
VMD-928 Tablet and Pembrolizumab (200 mg)
VMD-928 tablet (oral) starting at 300 mg daily for 21 days of 21-day cycle. Pemprolizumab at fixed intravenous dose of 200 mg once-every-21 days (per cycle) for max. 6 cycles.
Interventions
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VMD-928 100 mg Tablet
Taken orally once daily for 21 days per 21-day cycle
VMD-928 Tablet and Pembrolizumab (200 mg)
VMD-928 tablet (oral) starting at 300 mg daily for 21 days of 21-day cycle. Pemprolizumab at fixed intravenous dose of 200 mg once-every-21 days (per cycle) for max. 6 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Phase 1 Dose Escalation only: Subjects with
(A) any advanced solid tumors of
1. Head and Neck Cancers ("HNC") (of any types),
2. Esophageal cancer,
3. Lung cancers (of any types),
4. Mesothelioma,
5. 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
1. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,
2. 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:
1. Absolute neutrophil count ≥1.5x10\^9/L
2. Hemoglobin ≥9g/dL
3. Platelets ≥100x10\^9/L
4. PT/INR, PTT ≤1.5xULN
5. Total bilirubin ≤1.5x ULN
6. AST, ALT ≤2.5xULN
7. Creatinine ≤1.2xULN for age, weight
8. Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL/min
Exclusion Criteria
* 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.
* Known active infections including HIV disease.
* 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.
* Patient has had or is currently having other malignant tumors within 3 years.
* Patients have multiple factors that affect their oral medication.
* Patients have long-term unhealed wounds or fractures.
* Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.
* Patients are taking the following drugs and can't stop them during the study:
* Tylenol or medicine containing acetaminophen (paracetamol).
* Antacids (e.g. TUMS, calcium carbonate, or magnesium hydroxide), proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. famotidine), or buffered vitamins.
* Epstein-Barr virus (EBV) negative nasopharyngeal carcinoma.
For Phase 2 only:
* Negative result on TrkA immunohistochemistry (IHC) assay.
* Have visceral crisis, defined as severe organ dysfunction and rapid progression of the cancer. (It is not about presence of visceral metastasis.)
For combination therapy with Pembrolizumab only:
* Serious adverse immune related adverse events (grade 3 or 4) with previous PD-1(L1) inhibitor therapy, that were symptomatic and required prolong immunosuppression (\>6 weeks).
* Any grade Pneumonitis and Myocarditis related to prior PD-1(L1) inhibitor therapy.
* For subjects that received PD-1(L1) inhibitors before, there should be a washout period of at least 21 days between the last day of PD-1(L1) inhibitor and first day of study medications.
* Subjects who relapsed after prior treatment with PD-1(L1) inhibitors. Relapsed is defined as patients having best overall response of CR or PR after treatment with a PD-1(L1) inhibitor.
18 Years
80 Years
ALL
No
Sponsors
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VM Oncology, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development
Role: STUDY_CHAIR
VM Oncology
Locations
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Providence Medical Foundation (site 209)
Santa Rosa, California, United States
Hartford Hospital (site 210)
Hartford, Connecticut, United States
The George Washington University Cancer Center (site 212)
Washington D.C., District of Columbia, United States
Holy Cross Hospital (site 213)
Fort Lauderdale, Florida, United States
Memorial Cancer Institute at Memorial Healthcare Systems (site 132)
Pembroke Pines, Florida, United States
Englewood Hospital and Medical Center (site 202)
Englewood, New Jersey, United States
Summit Medical Group (site 205)
Florham Park, New Jersey, United States
Atlantic Health System, Morristown Medical Center (site 124)
Morristown, New Jersey, United States
Presbyterian Kaseman Hospital (site 208)
Albuquerque, New Mexico, United States
Weill Cornell Medicine, Cornell University (site 126)
New York, New York, United States
Taylor Cancer Research Center (site 204)
Maumee, Ohio, United States
Cancer Care Associates of York (site 206)
York, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center (site 127)
Houston, Texas, United States
Utah Cancer Specialists (site 203)
Salt Lake City, Utah, United States
PanOncology Trials, Hospital Oncologico - Puerto Rico Medical Center, Río Piedras (site 200)
San Juan, , Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VMO-01C
Identifier Type: -
Identifier Source: org_study_id
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