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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Dose escalation of CM24 with nivolumab in adult patients with selected recurrent or metastatic solid tumors
Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine in adult patients with advanced metastatic pancreatic cancer
Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer
Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabine in adult patients with advanced metastatic pancreatic cancer
Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer
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
...and 8 more locations
Part A: Incidence of treatment emergent adverse events
Incidence of treatment emergent adverse events with CM-24 and nivolumab in adults with selected recurrent or metastatic solid tumors
Time frame: Up to 24 months
Part C: Safety and tolerability
Incidence of treatment emergent adverse events with CM-24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV in adults with advanced metastatic pancreatic cancer
Time frame: Up to 24 months
Part D: Overall survival
This is an exploratory randomized sub-study with the objective of estimating the efficacy of CM24 and nivolumab with chemotherapy (Nal-IRI/5-FU/LV or gemcitabine/ nab-paclitaxel) and chemotherapy only (Nal- IRI/5-FU/LV or gemcitabine/nab-paclitaxel) as measured by overall survival.
Time frame: Up to 24 months
Maximum serum concentration [Cmax]
Maximum serum concentration \[Cmax\] of CM24
Time frame: Up to 24 months
Time of maximum concentration [Tmax]
Time of maximum concentration \[Tmax\] of CM24
Time frame: Up to 24 months
Area under the serum concentration curve [AUC]
Area under the serum concentration curve \[AUC\] of CM24
Time frame: Up to 24 months
Half life
Half life of CM24
Time frame: Up to 24 months
Drug clearance
Drug clearance of CM24
Time frame: Up to 24 months
Volume of distribution
Volume of distribution of CM24
Time frame: Up to 24 months
Serum ADA parameters
Serum ADA parameters of CM24 as measured by percentage of patients who are positive for the presence of anti-drug antibodies
Time frame: Up to 24 months
Objective Response Rate when CM24 is used in combination with nivolumab
Time frame: Up to 24 months
Disease Control Rate when CM24 is used in combination with nivolumab
Time frame: Up to 24 months
Median Duration of Response when CM24 is used in combination with nivolumab
Time frame: Up to 24 months
Median Time to Response when CM24 is used in combination with nivolumab
Time frame: Up to 24 months
Progression Free Survival when CM24 is used in combination with nivolumab
Time frame: Up to 48 months
Overall Survival when CM24 is used in combination with nivolumab
Time frame: Up to 48 months
Population pharmacokinetics when CM24 is used in combination with nivolumab as measured by the maximum plasma concentration [Cmax]
Time frame: Up to 24 months
Population pharmacokinetics when CM24 is used in combination with nivolumab as measured by the average area under the concentration curve [AUC]
Time frame: Up to 24 months
Population pharmacokinetics when CM24 is used in combination with nivolumab as measured by the median area under the concentration curve [AUC]
Time frame: Up to 24 months
Population pharmacokinetics when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV as measured by the maximum plasma concentration [Cmax]
Time frame: Up to 24 months
Population pharmacokinetics when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV as measured by the average area under the concentration curve [AUC]
Time frame: Up to 24 months
Population pharmacokinetics when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV as measured by the median area under the concentration curve [AUC]
Time frame: Up to 24 months
Disease Control Rate when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV
Time frame: Up to 24 months
Duration of Response when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV
Time frame: Up to 24 months
Time to Response when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV
Time frame: Up to 24 months
Progression Free Survival when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV
Time frame: Up to 48 months
Overall Survival when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV
Time frame: Up to 48 months
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