NCT02697591

A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Incyte Biosciences International Sàrl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in participants with advanced or metastatic solid tumors that was conducted in 2 parts. Part 1 is dose escalation and safety expansion which determines the optimal dose and maximum number of tolerated doses. Part 2 is dose expansion in which Part 1 recommended dose will be evaluated.

Conditions

• Advanced Malignancies
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	INCAGN01876	Initial cohort dose of INCAGN01876 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.

Timeline

• Start date: 2016-06-20
• Primary completion: 2019-12-16
• Completion: 2019-12-16
• First posted: 2016-03-03
• Last updated: 2021-02-26
• Results posted: 2021-02-26

Locations

8 sites across 1 country: United States