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

Has cardiac, hepatic, endocrine, pulmonary, or autoimmune disease, interstitial lung disease, renal or psychiatric disorders, not controlled with therapy corresponding to the illness or a condition that contraindicates the use of a taxane or an EGFR inhibitor.

Has Cirrhosis of liver at a level of Child-Pugh B (or worse).

Has uncontrolled brain metastases. Patients are allowed if brain metastasis has been previously treated with surgery, whole brain irradiation, and/or stereotactic radiosurgery and are considered controlled (controlled by the dose ≤10 mg/day of prednisone or equivalent) at the time of the first dose of investigational product. Radiological evaluation of brain metastasis will be performed only if the patient has symptoms. For asymptomatic patients, brain imaging during screening is not required.

Has baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval \>480 milliseconds \[CTCAE Grade 1\] using Fredericia's QT correction formula).

Has a history of additional risk factors for Torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).

Has had prior cetuximab therapy for recurrent or metastatic disease. Note that cetuximab used concomitantly with radiotherapy or as an induction therapy is acceptable

Has received any other EGFR-targeted therapies for recurrent or metastatic disease.

Currently participating in any clinical trial or receiving investigational therapy on expanded access or compassionate basis.

Has nasopharyngeal carcinomas or salivary gland cancers.

Female patient who tested positive for pregnancy.

Female patient who is breastfeeding or planning to become pregnant, or male patient planning to father a child within the duration of the study.

Has tested positive for HIV, HBsAg, HCV antibody, or HCV RNA at screening. However, patients who test positive for HCV antibody, but negative for HCV RNA, will be allowed. In addition, patients with controlled HIV, chronic HBV on suppressive antiviral therapy, or a history of HCV infection status post-curative antiviral treatment with an HCV viral load below limit of quantification are permitted to participate (DHHS 2020).

Has active infection requiring intravenous anti-infective therapy within 7 days prior to Day 1 Cycle 1 or is febrile due to infection.

Has had major surgery within 4 weeks prior to screening.

Administered a live attenuated vaccine within 4 weeks prior to Day 1 Cycle 1 or anticipation that such a live attenuated vaccine will be required during the study.

Has known or suspected hypersensitivity to any components of the formulation used for this investigational product.

Has concurrent disease or any clinically significant abnormality following the investigator's review of the screening physical examination findings, 12-lead ECG results, and clinical laboratory tests, which in the judgment of the investigator would interfere with the patient's participation in this study or evaluation of study results.

Unable to come for study visits per schedule.

Has current drug or alcohol abuse.

Has received prior treatment with paclitaxel or docetaxel or any other drugs with taxane like mode of action for recurrent or metastatic or recurrent HNSCC. However, prior paclitaxel or docetaxel or any other drugs with taxane like mode of action as a component of a curatively-intended multimodality treatment for locally advanced HNSCC is permitted.

What this study is about