NCT02929862

Study of LYC-55716 in Adult Subjects With Locally Advanced or Metastatic Cancer

A Phase 1/2A Multicenter, Open-Label Study of LYC-55716 in Adult Subjects With Locally Advanced or Metastatic Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Lycera Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2A study designed to evaluate the safety and tolerability of increased repeated doses of LYC-55716 in subjects with locally advanced or metastatic solid tumors.

Detailed description

Approximately 30 subjects across approximately 5 United States (US) sites will be enrolled in the Phase 1 portion of the study and approximately 69-84 subjects across approximately 15 US sites will be enrolled in the Phase 2A portion of the study. The Phase 1 portion of the study will follow a 3 + 3 dose-escalation design to evaluate twice-daily (BID) administration of LYC-55716 for DLTs and to determine the MTD and the RP2D for further assessment in Phase 2A. A treatment cycle will consist of 28 days of treatment and subjects may continue to receive subsequent cycles of therapy as long as they do not have clinically significant progressive disease. In the Phase 2A portion of the study, 69-84 subjects with locally advanced or metastatic solid tumors considered most likely to be responsive to a RORγ agonist will be enrolled and treated at the MTD or RP2D. Six cohorts of subjects with advanced cancer will be enrolled. Cohorts 1 to 3 will enroll 14 to 19 subjects per cohort. Tumor types include NSCLC (Cohort 1); gastric, esophageal and G-E junction adenocarcinoma (Cohort 2); and SCCHN (Cohort 3). Cohorts 4 to 6 will enroll up to 9 subjects per cohort. Tumor types include ovarian carcinoma (Cohort 4), renal cell carcinoma (Cohort 5), and urothelial carcinoma (Cohort 6). Primary Study Objectives Phase 1 * Evaluate the safety and tolerability of LYC-55716 * Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Phase 2A • Determine the objective response rate according to response evaluation criteria in solid tumors (RECIST) v1.1. Secondary Study Objectives Phase 1 * Evaluate the activity of LYC-55716 by objective response according to RECIST v1.1. * Determine the durability of any observed objective response Phase 2A * Determine the duration of response * Determine progression-free survival (PFS) and overall survival (OS) * Determine suitability of the RP2D for further study * Characterize the pharmacokinetics (PK) of LYC-55716

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	LYC-55716	For Phase 1, increasing doses of oral 55716 given BID for a 28 day cycle. For Phase 2A, the RP2D will be administered to patients for 28 day cycles.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2016-10-11
• Last updated: 2019-09-25

Locations

20 sites across 1 country: United States