Primary Outcome Measures:
- Number of subjects reporting adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ]
- Number of subjects reporting serious adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ]
- Number of subjects experiencing dose-limiting toxicities [ Time Frame: First dose of study medications through 4 weeks after the first dose of study medication ]
- Change from Baseline in laboratory evaluations [ Time Frame: Screening through 90 days after the last dose of study medication ] ]
- Change from Baseline in electrocardiograms [ Time Frame: Screening through 90 days through last dose of study medication ]
- Change from Baseline in vital signs [ Time Frame: Screening through 90 days after the last dose of study medication ]
Secondary Outcome Measures:
- Objective Response Rate [ Time Frame: Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
- Disease Control Rate [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
- Duration of Response [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
- Individual Durvalumab concentrations [ Time Frame: First dose of Durvalumab through 3 months after the last dose of study medication ]
- Individual IPH2201 Concentration [ Time Frame: First dose of IPH2201 through 3 months after the last dose of study medication ]
- Durvalumab area under the concentration-curve [ Time Frame: First dose of Durvalumab through 3 months after the last dose of study medication ]
- IPH2201 area under the concentration-curve [ Time Frame: First dose of IPH2201 through 3 months after the last dose of study medication ]
- Number of subjects and percentage of subjects who develop detectable anti-drug antibodies [ Time Frame: First dose of Durvalumab through 3 months after the last dose of study medication ]
- Progression Free Survival [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
- Overall Survival [ Time Frame: Screening through 5 years after the last subject receives the first dose of study medication ]
This is a Phase 1, multicenter, open-label, single-arm dose-escalation and dose-expansion study of durvalumab in combination with IPH2201 to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and antitumor activity in adult subjects with selected advanced solid tumors. The study consists of 2 parts: dose escalation and dose expansion.
Subjects will receive durvalumab and IPH2201 via 2 separate IV infusions. Subjects will receive durvalumab and IPH2201 until unacceptable toxicity, documentation of confirmed progressive disease (PD), or documentation of subject withdrawal for another reason.
