RecruitingPhase 1Phase 2NCT03476681

Study of NEO-201 in Solid Tumors Expansion Cohorts

Phase 1/2 With Expansion Cohorts in a Study of NEO-201 in Adults With Chemo-Resistant Solid Tumors


Sponsor

Precision Biologics, Inc

Enrollment

121 participants

Start Date

Jan 18, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called NEO-201 in patients with specific advanced solid tumors — including non-small cell lung cancer, head and neck cancer, uterine cancer, and cervical cancer — whose cancer has returned or spread despite standard treatments. **You may be eligible if...** - You are 18 or older - You have confirmed advanced, unresectable, or metastatic cancer in one of these specific types: non-small cell lung cancer, head and neck squamous cell carcinoma (HNSCC), uterine cancer, or cervical cancer - Your tumor tests positive for the NEO-201 target protein (at least 10% of tumor cells) - Your cancer has progressed during or after at least one prior standard treatment (chemotherapy and/or targeted therapy) - You cannot be cured by surgery or radiation - Your disease is measurable on scans - For lung cancer: your tumor must express PD-L1 or have specific genetic features; patients with EGFR/ALK/ROS1/BRAF mutations must have already tried approved targeted drugs **You may NOT be eligible if...** - Your tumor does not express the NEO-201 target - You have not yet tried standard first-line treatments appropriate for your cancer type - You are unable or unwilling to provide tumor tissue for testing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNEO-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.


Locations(2)

National Cancer Institute

Bethesda, Maryland, United States

INOVA Schar Cancer Institute

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT03476681


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