Actively Recruiting
Study of NEO-201 in Solid Tumors Expansion Cohorts
Led by Precision Biologics, Inc · Updated on 2025-04-24
121
Participants Needed
2
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of NEO-201 in Solid Tumors Expansion Cohorts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed recurrent, locally advanced unresectable or metastatic cancer
- Diagnosed with advanced non-small cell lung cancer, head and neck squamous cell carcinoma, cervical or uterine cancer progressed during or after at least one frontline standard treatment
- Tumor expresses NEO-201 antigen in at least 10% of tumor cells
- Not a candidate for potentially curative surgery or radiation
- For NSCLC: tumor expresses PD-L1 (TSP > 1%) or is MSI-H, mismatch repair deficient, or TMB-H
- For NSCLC patients with EGFR, ALK1, ROS1, or BRAF V600E mutations, progression on FDA-approved agents required
- For NSCLC patients without these mutations, prior immune-checkpoint inhibitor treatment required
- For cervical cancer: tumor expresses CPS > 1 or is MSI-H, mismatch repair deficient, or TMB-H
- For HNSCC: prior pembrolizumab treatment allowed
- For uterine carcinoma: prior pembrolizumab plus lenvatinib treatment unless unsafe
- Available archived tissue or willingness to undergo safe tumor biopsy
- Measurable disease by RECIST v1.1
- ECOG performance status of 2 or less, or Karnofsky score 50% or higher
- Adequate organ function based on specified laboratory values
- Specified time elapsed since prior therapies including chemotherapy, monoclonal antibodies, tyrosine kinase inhibitors, corticosteroids, immunotherapy, and radiation
- Recovery from acute toxicities of prior therapies except for alopecia
- Ability to remain on study protocol for at least 8 weeks
- For females: post-menopausal, surgically sterilized, or willing to use acceptable birth control during study and specified post-treatment periods
- For males: agree to use adequate contraception during study and specified post-treatment periods
You will not qualify if you...
- History of uncontrolled or disseminated brain metastases or central nervous system disease
- Allergic reactions to NEO-201 or similar agents
- Major surgery within 14 days before enrollment
- Receiving other investigational agents
- No archival tissue or unsafe/unwilling for tumor biopsy
- Uncontrolled illnesses such as active infections, uncontrolled diabetes, symptomatic heart failure, unstable angina, hypokalemia, family history of Long QT Syndrome, or cardiac arrhythmia
- High risk of infection from neutropenia as assessed by investigator
- HIV-positive on combination antiretroviral therapy
- Other serious medical or psychiatric illnesses interfering with study participation
- Pregnant or breastfeeding women
- Immunodeficiency or chronic systemic steroid therapy exceeding 10 mg prednisone equivalent within 7 days before study
- Active autoimmune disease requiring systemic treatment in past 2 years except replacement therapies
- Severe or life-threatening immune-related adverse events with prior immune checkpoint therapy requiring permanent discontinuation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
National Cancer Institute
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
INOVA Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
A
Ann McCoy, RN
CONTACT
E
Erica Redmond, BSN,RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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