OncoMatch/Clinical Trials/NCT03476681
Study of NEO-201 in Solid Tumors Expansion Cohorts
Is NCT03476681 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies NEO-201 in combination with pembrolizumab for non small cell lung cancer.
Treatment: NEO-201 in combination with pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Cervical Cancer
Endometrial Cancer
Biomarker criteria
Allowed: PD-L1 (CD274) overexpression
Tumor(s) must express PD-L1 (TSP > 1%) as determined by an FDA-approved test
Allowed: EGFR genomic tumor aberration
Patients with EGFR, ALK1, ROS1 or BRAF V600E genomic tumor aberrations must have had disease progression on FDA-approved agents for these aberrations.
Allowed: ALK genomic tumor aberration
Patients with EGFR, ALK1, ROS1 or BRAF V600E genomic tumor aberrations must have had disease progression on FDA-approved agents for these aberrations.
Allowed: ROS1 genomic tumor aberration
Patients with EGFR, ALK1, ROS1 or BRAF V600E genomic tumor aberrations must have had disease progression on FDA-approved agents for these aberrations.
Allowed: BRAF V600E
Patients with EGFR, ALK1, ROS1 or BRAF V600E genomic tumor aberrations must have had disease progression on FDA-approved agents for these aberrations.
Disease stage
Metastatic disease required
recurrent, locally advanced unresectable or metastatic cancer
Performance status
ECOG OR KARNOFSKY 0–2
ECOG ≤ 2; or Karnofsky performance status of ≥ 50%
Prior therapy
Must have received: standard of care treatment — front-line
has progressed during or after at least one front-line standard of care treatment, including chemotherapy and/or targeted therapy
Lab requirements
Blood counts
Hemoglobin > 9 g/dL, or on stable doses (hematocrit stable within 1 gram and dose stable for one month) of erythropoietin or similar medication; Absolute neutrophil count (ANC) ≥1,500/mm3; Platelets ≥ 100,000/mm3
Kidney function
Creatinine ≤ 1.5 mg/dL or creatinine clearance > 40 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal, as calculated by the Cockcroft Gault formula
Liver function
Total bilirubin ≤ 2.0 mg/dL; ALT and AST ≤ 3 times the ULN, or, if the subject has liver metastases, ≤ 5 times the ULN
Subject must have adequate organ function: Hemoglobin > 9 g/dL... ANC ≥1,500/mm3; Platelets ≥ 100,000/mm3; Total bilirubin ≤ 2.0 mg/dL; ALT and AST ≤ 3 times the ULN, or, if the subject has liver metastases, ≤ 5 times the ULN; Creatinine ≤ 1.5 mg/dL or creatinine clearance > 40 mL/min/1.73 m2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Cancer Institute · Bethesda, Maryland
- INOVA Schar Cancer Institute · Fairfax, Virginia
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