Study of LYC-55716 in Adult Subjects With Locally Advanced or Metastatic Cancer
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|ClinicalTrials.gov Identifier: NCT02929862|
Recruitment Status : Recruiting
First Posted : October 11, 2016
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: LYC-55716||Phase 1 Phase 2|
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
- Evaluate the safety and tolerability of LYC-55716
- Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)
• Determine the objective response rate according to response evaluation criteria in solid tumors (RECIST) v1.1.
Secondary Study Objectives
- Evaluate the activity of LYC-55716 by objective response according to RECIST v1.1.
- Determine the durability of any observed objective response
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2A Multicenter, Open-Label Study of LYC-55716 in Adult Subjects With Locally Advanced or Metastatic Cancer|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
|Experimental: Single Agent 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.
- Assess Tumor Activity [ Time Frame: 8 weeks ]Evaluated according to RECIST v1.1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929862
|Contact: H. Jeffrey Wilkins, MD||484-243-6222|
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