At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Histologically or cytologically confirmed recurrent, locally advanced unresectable or metastatic cancer
- ✓Advanced NSCLC, HNSCC, uterine cancer, or cervical cancer with progression during or after at least one front-line standard of care treatment
- ✓Tumor positive for NEO-201 antigen expression (at least 10% of tumor cells)
- ✕History of disseminated or uncontrolled brain metastases or CNS disease (unless stable on consecutive MRIs 2+ months apart and seizure-free)
- ✕History of allergic reactions to NEO-201 or similar compounds
- ✕Major surgery within 14 days of enrollment
- ✕Currently receiving other investigational agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1/2 With Expansion Cohorts in a Study of NEO-201 in Adults With Chemo-Resistant Solid Tumors
In Brief
A Phase 1 clinical trial evaluating NEO-201 in combination with pembrolizumab for Non Small Cell Lung Cancer and 3 related conditions. Active but no longer recruiting, targeting 121 participants across 2 sites.
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
Subjects will receive 3 doses NEO-201 in combination with one dose of pembrolizumab in a 42 day cycle. This course will be repeated in the absence of disease progression or unacceptable toxicity.
Interventions
NEO-201 will be given intravenously every 2 weeks in combination with pembrolizumab. In each cycle subjects will receive 3 doses of NEO 201 and one dose of pembrolizumab.