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Brief Title: A Study of CM24 in Combination With Nivolumab in Adults With Advanced Solid Tumors
Official Title: A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CM24 in Combination With Nivolumab in Adults With Advanced Solid Tumors
Study ID: NCT04731467
Brief Summary: This is an open-label, multicenter, multi-dose escalation and dose expansion study in subjects with selected advanced solid tumors (Part A) and advanced metastatic pancreatic cancer (Parts C \& D) to evaluate the safety and tolerability of CM-24 in combination with nivolumab. In Part C of the study gemcitabine/nab-paclitaxel or Nal-IRI/5-FU/LV will be administered subsequent to CM24 and nivolumab. CM24, nivolumab and gemcitabine/nab-paclitaxel or Nal-IRI/5-FU/LV are administered intravenously.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
HonorHealth Research Institute, Scottsdale, Arizona, United States
University of Colorado, Aurora, Colorado, United States
Yale University, New Haven, Connecticut, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Rambam Health Care Campus, Haifa, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Hospital Clinic Barcelona, Barcelona, , Spain
NEXT Oncology Barcelona, Barcelona, , Spain
Vall d' Hebron Institute of Oncology (VHIO), Barcelona, , Spain
Clinica Universidad de Navarra, Madrid, , Spain
Hospital 12 Octubre, Madrid, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC, Madrid, , Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz, Madrid, , Spain
Clinica Universidad de Navarra - Pamplona, Pamplona, , Spain
NEXT Oncology Madrid, Pozuelo de Alarcon, , Spain
Hospital Quiron Salud Valencia, Valencia, , Spain
Name: Michael Schickler, PhD
Affiliation: Famewave Ltd.
Role: STUDY_DIRECTOR