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Recruiting Phase 2 Interventional

Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy

ClinicalTrials.gov ID: NCT05283226

Public ClinicalTrials.gov record NCT05283226. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 1:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2 Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 2, open-label, multicenter, single-arm study of NRC-2694-A in combination with paclitaxel in patients with R/M HNSCC with progression on or after ICI therapy. A total of approximately 46 male and female patients will be enrolled. This sample size is based on Simon's 2-stage design with historical control ORR of 30% and a target ORR of 50%.

Study identification

NCT ID
NCT05283226
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
NATCO Pharma Ltd.
Industry
Enrollment
21 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 29, 2022
Primary completion
Dec 29, 2026
Completion
Jun 29, 2027
Last update posted
Jan 22, 2026

2022 – 2027

United States locations

U.S. sites
10
U.S. states
8
U.S. cities
10
Facility City State ZIP Site status
Providence Medical Foundation -Fullerton Fullerton California 92835 Completed
Los Angeles Hematology Oncology Medical Group Los Angeles California 90017 Completed
Lynn Cancer Center Boca Raton Florida 33486 Completed
Miami Cancer Center Miami Florida 33176 Completed
Norton Cancer Institute - Downtown Louisville Kentucky 40202 Completed
University of Maryland Greenebaum Cancer Center Baltimore Maryland 21201-1544 Completed
Washington University - Siteman Cancer Center St Louis Missouri 63110 Completed
Dartmouth Hitchcock Medical Center Lebanon New Hampshire 03756-1000 Completed
Salib Oncology Easton Pennsylvania 18045 Completed
University of Wisconsin Carbone Cancer Center Madison Wisconsin 53792 Completed

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05283226, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 22, 2026 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05283226 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →