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Study of NEO-201 in Solid Tumors Expansion Cohorts

NCT03476681 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2025-04-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

NEO-201 in combination with pembrolizumab

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.

Sponsors & Collaborators

  • Precision Biologics, Inc

    lead INDUSTRY

Principal Investigators

  • Kevin Conlon, MD · National Cancer Institute - Women's Malignancy Branch

  • Azam Ghafoor, MD · National Cancer Institute - Thoracic and GI Malignancy Branch

  • Charalampos Floudas, MD · National Cancer Institute - Head and Neck/GUMB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-18
Primary Completion
2028-01-15
Completion
2029-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03476681 on ClinicalTrials.gov