Actively Recruiting
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
Led by NATCO Pharma Ltd. · Updated on 2026-01-23
21
Participants Needed
13
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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%.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide signed informed consent and follow study rules
- Male or female aged 18 years or older
- Histologically confirmed unresectable recurrent or metastatic head and neck squamous cell carcinoma
- Documented disease progression according to RECIST v1.1
- At least one measurable tumor lesion per RECIST v1.1
- ECOG performance status score of 2 or less
- Disease progression during or after immune checkpoint inhibitor therapy like pembrolizumab or nivolumab
- Female patients of childbearing potential must have a negative pregnancy test before enrollment
- Patients of reproductive age must use effective contraception during the study and for 30 days after last dose
- Adequate bone marrow, kidney, and liver function per defined laboratory values
- At least two weeks since stopping prior immune checkpoint or investigational therapy with recovery to grade 1 or less toxicity
You will not qualify if you...
- Uncontrolled cardiac, liver, endocrine, lung, autoimmune, renal, or psychiatric disease
- Cirrhosis of liver at Child-Pugh B level or worse
- Uncontrolled brain metastases; controlled brain metastases allowed with low-dose steroids
- Baseline prolonged QT/QTc interval or risk factors for Torsade de pointes
- Prior cetuximab or other EGFR-targeted therapy for recurrent or metastatic disease
- Currently enrolled in another clinical trial or receiving investigational therapy
- Nasopharyngeal carcinoma or salivary gland cancers
- Positive pregnancy test, breastfeeding, or planning pregnancy during study
- Positive for HIV, active hepatitis B or C infection unless controlled or treated as specified
- Active infection requiring IV antibiotics or fever within 7 days before treatment
- Major surgery within 4 weeks prior to screening
- Live attenuated vaccine within 4 weeks before treatment or planned during study
- Known allergy to study drug components
- Any condition that would interfere with study participation or evaluation
- Unable to attend scheduled study visits
- Current drug or alcohol abuse
- Prior treatment with paclitaxel, docetaxel, or similar taxane drugs for recurrent or metastatic disease, except as part of curative treatment for locally advanced disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Providence Medical Foundation -Fullerton
Fullerton, California, United States, 92835
Completed
2
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, United States, 90017
Completed
3
Lynn Cancer Center
Boca Raton, Florida, United States, 33486
Completed
4
Miami Cancer Center
Miami, Florida, United States, 33176
Completed
5
Norton Cancer Institute - Downtown
Louisville, Kentucky, United States, 40202
Completed
6
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1544
Completed
7
Washington University - Siteman Cancer Center
St Louis, Missouri, United States, 63110
Completed
8
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-1000
Completed
9
Salib Oncology
Easton, Pennsylvania, United States, 18045
Completed
10
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Completed
11
Daycare Angels under AOH
Mumbai, Maharashtra, India, 40001
Actively Recruiting
12
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, India, 411001
Completed
13
Basavatarakam Indo American Cancer Hospital & Research Institute
Hyderabad, Telangana, India, 500034
Not Yet Recruiting
Research Team
P
Praveen Myneni, MBBS
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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