Cancer Clinical Trial - Study of LYC-55716 in Adult Subjects With Locally

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02929862
Study type	Interventional
Source	Lycera Corp.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	December 2016
Completion date	May 31, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms