CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
INCAGN01876drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02697591
NCT02697591Phase 2Completed
CompareCT.gov

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

Incyte Biosciences International Sàrl·interventional·Posted Mar 3, 2016·Updated Feb 26, 2021

In Brief

A Phase 2 clinical trial evaluating INCAGN01876 for Advanced Malignancies and Metastatic Cancer. Completed, enrolled 100 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Malignancies, Metastatic Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 3, 2016
Enrollment StartJun 20, 2016
Primary CompletionDec 16, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.3 years ago

Interventions

INCAGN01876drug

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.