RecruitingPhase 1/2

VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma

United States242 participantsStarted 2018-06-08

Plain-language 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

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Head and Neck Cancers ("HNC") (of any types),
✓. Esophageal cancer,
✓. Lung cancers (of any types),
✓. Mesothelioma,
✓. Pancreatic cancers,
✓. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,
✓. any NTRK1+ solid tumors or lymphoma\*, that is R/R/I to SOC.
✓. Absolute neutrophil count ≥1.5x10\^9/L

What they're measuring

Number and severity of treatment-emergent Adverse Events (Phase 1)

Timeframe: First cycle (21 days per cycle)

To determine the recommended Phase 2 dose for VMD-928 (Phase 1)

Timeframe: First cycle (21 days per cycle)

To determine the RP2D of VMD-928 in combination with pembrolizumab (Phase 1)

Timeframe: First cycle (21 days per cycle)

Antitumor activity of VMD-928 in subjects with TrkA-driven tumors (Phase 2)

Timeframe: Up to 18 months

Antitumor activity of VMD-928 in combination with pembrolizumab in subjects with TrkA-driven tumors (Phase 2)

Timeframe: Up to 18 months

Trial details

NCT IDNCT03556228

SponsorVM Oncology, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Jay Wu, PhD

1-510-270-2790 OM@VMOncology.com

View on ClinicalTrials.gov More Head and Neck Carcinoma trials