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Brief Title: A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
Official Title: A Phase 1/2 Study With Open-Label, Dose Escalation Phase Followed by Single-Arm Expansion at the Maximum Tolerated Dose to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of NT219 Injection Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
Study ID: NCT04474470
Brief Summary: This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or metastatic solid tumors.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
California Cancer Associates for Research and Excellence, Encinitas, California, United States
The Angeles Clinic and Research Institute, Los Angeles, California, United States
UCSD Moores Cancer Center, San Diego, California, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
The University of Chicago and Biological Sciences, Chicago, Illinois, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Hadassah University Medical Center, Jerusalem, , Israel
Rabin Medical Center, Petah tikva, , Israel
Sourasky Medical Center, Tel Aviv, , Israel
Name: Michael Schickler, PhD
Affiliation: TyrNovo Ltd.
Role: STUDY_DIRECTOR