Study of NEO-201 in Solid Tumors Expansion Cohorts

The open label, first-in-human, phase 1, dose escalation component in refractory solid tumors has been completed. The Maximum Tolerated Dose and Recommended Phase 2 Dose (RP2D) was determined to be 1.5mg/kg. The Expansion Phase of this study is currently enrolling subjects with non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), cervical and uterine cancers who progressed on front line therapy. Subjects will be treated with NEO-201 at the RP2D (1.5 mg/kg) every 2 weeks in combination with pembrolizumab, given 1 day after the NEO-201, at 400 mg IV every 6 weeks.

Trial Details

NCT ID
NCT03476681
Phase
PHASE1 / PHASE2
Sponsor
Precision Biologics, Inc
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • NEO-201 in combination with pembrolizumab
Locations (sample)
  • Bethesda, Maryland, United States|38.98067,-77.10026
  • Fairfax, Virginia, United States|38.84622,-77.30637

Key Eligibility Criteria

  • Age: \>/=18 years
  • Diagnosis:
  • Subjects must have histologically or cytologically confirmed recurrent, locally advanced unresectable or metastatic cancer confirmed by the Laborat…
  • Subjects enrolled in the expansion cohorts must have advanced non-small cell lung cancer, HNSCC, uterine cancer, or cervical cancer that has progre…

For full eligibility, visit ClinicalTrials.gov.

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