RecruitingPhase 2NCT05283226

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

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


Sponsor

NATCO Pharma Ltd.

Enrollment

21 participants

Start Date

Sep 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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%.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called NRC-2694-A combined with weekly paclitaxel (a standard chemotherapy drug) in patients with head and neck squamous cell carcinoma (HNSCC) — a cancer of the mouth, throat, or voice box — that has come back or spread and stopped responding to immunotherapy. **You may be eligible if...** - You are 18 or older with confirmed HNSCC that cannot be surgically removed and has progressed after immunotherapy (such as pembrolizumab or nivolumab) - You have not previously received taxane-based chemotherapy (e.g., paclitaxel or docetaxel) for your recurrent or metastatic disease - Your overall health and blood counts are adequate **You may NOT be eligible if...** - You have uncontrolled brain metastases - You have significant heart, liver, lung, kidney, or autoimmune conditions - You have nasopharyngeal or salivary gland cancer - You are currently in another clinical trial - You are pregnant, breastfeeding, or HIV/hepatitis positive (with exceptions for controlled disease) 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

DRUGNRC-2694-A

300 mg orally once daily

DRUGPaclitaxel

175 mg/m² IV infusion over approximately 3 hours


Locations(13)

Providence Medical Foundation -Fullerton

Fullerton, California, United States

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States

Lynn Cancer Center

Boca Raton, Florida, United States

Miami Cancer Center

Miami, Florida, United States

Norton Cancer Institute - Downtown

Louisville, Kentucky, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Washington University - Siteman Cancer Center

St Louis, Missouri, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Salib Oncology

Easton, Pennsylvania, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Daycare Angels under AOH

Mumbai, Maharashtra, India

Grant Medical Foundation Ruby Hall Clinic

Pune, Maharashtra, India

Basavatarakam Indo American Cancer Hospital & Research Institute

Hyderabad, Telangana, India

View Full Details on ClinicalTrials.gov

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NCT05283226


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