This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of IPH5401 (anti C5aR) in combination with Durvalumab (MEDI4736) in Adult Subjects with selected advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
IPH5401 and durvalumab
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States
ICAHN School of Medicine at Mount Sinai
New York, New York, United States
Occurrence of Drug Limited Toxicities (DLTs)
To assess the occurrence of Drug Limited Toxicities (DLTs)
Time frame: From Time of First dose assessed up to 6 weeks
Adverse events (AEs)
To evaluate the safety profile
Time frame: From screening visit up to 30 days after the last dose of study medication
Objective Response Rate
Rate of patients in complete or partial response according to RECIST 1.1
Time frame: up to 12 months
Duration of Response
duration between the complete or partial response and the first documented progression
Time frame: 2 years and 9 months
Progression Free Survival
time between the start of treatment and the first documented progression or death
Time frame: 2 years and 9 months
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Sarah Cannon Research Institute
Nashville, Tennessee, United States
NEXT Oncology
San Antonio, Texas, United States
Centre Georges-Francois Leclerc
Dijon, France
Centre Leon Berard
Lyon, France
Hôpital de la Timone- AP-HM
Marseille, France
Institut du Cancer de Montpellier
Montpellier, France
Centre Hospitalier Universitaire- Hôpital Nord Laennec
Nantes, France
...and 2 more locations