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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02929862
Recruitment Status : Completed
First Posted : October 11, 2016
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Lycera Corp.

Tracking Information
First Submitted Date  ICMJE October 5, 2016
First Posted Date  ICMJE October 11, 2016
Last Update Posted Date September 25, 2019
Study Start Date  ICMJE December 2016
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2017)
Assess Tumor Activity [ Time Frame: 8 weeks ]
Evaluated according to RECIST v1.1
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
Assess Tumor Activity [ Time Frame: 8 weeks ]
Evaluated according to RECIST
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of LYC-55716 in Adult Subjects With Locally Advanced or Metastatic Cancer
Official Title  ICMJE A Phase 1/2A Multicenter, Open-Label Study of LYC-55716 in Adult Subjects With Locally Advanced or Metastatic Cancer
Brief 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Single Agent 55716
Intervention: Drug: LYC-55716
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2019)
119
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2016)
90
Actual Study Completion Date  ICMJE May 31, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is male or female and at least 18 years of age.
  • Histological or cytological confirmation of advanced unresectable solid tumors, including those subjects who have progressed on standard anticancer therapy and for whom no further therapy that confers clinical benefit is available.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) score of 0 1 or Karnofsky Performance Status Score ≥ 70.
  • Subject has a life expectancy of at least 12 weeks.
  • Subject has adequate organ function as determined by the following laboratory values:

    • Absolute Neutrophil Count* ≥ 1,500/mm3 (≥ 1.5 x 109/L)
    • Platelets* ≥ 100,000/mm3 (≥ 100 x 109/L)
    • Lymphocytes ≥ 0.5 x 109/L
    • Hemoglobin* > 9.0 g/dL
    • Serum Creatinine or Creatinine Clearance** ≤ 1.5 x ULN, > 50 mL/min
    • Total Serum Bilirubin ≤ 1.5 x ULN (< 3.0 mg/dL if subject has Gilbert's syndrome)
    • Liver Transaminases (ALT/AST) ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver metastases present

      • (* = without ongoing growth factor or transfusion support)
      • (** = calculated by Cockcroft and Gault's formula)
      • (ALT = alanine aminotransferase, AST = aspartate aminotransferase, ULN = upper limit of normal)

Exclusion Criteria:

  • Subject has received an investigational drug in the 28 day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another interventional clinical trial.
  • Subject has known symptomatic brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Subjects with stable asymptomatic brain metastases or leptomeningeal disease are eligible if they have not required new treatments for this disease in a 28 day period before the first dose of study drug, and anticonvulsants and steroids have not been administered for a period of 2 weeks prior to the first dose of study drug.
  • Subject has not recovered from adverse reactions to prior cancer treatment or procedures (surgery, chemotherapy, immunotherapy, radiation therapy) to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or better.
  • Subject has a previous (within 5 years) or current malignancy other than the target cancer with the exception of curatively treated local tumors such as carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade < 6 and prostate-specific antigen within normal range.

Modifications to Eligibility Criteria for the following specific tumor types:

Phase 2A will be limited to enrolling the following tumor types:

  • NSCLC
  • Gastric, Esophageal, and G-E Junction Adenocarcinoma
  • SCCHN
  • Ovarian Carcinoma
  • Renal Cell Carcinoma
  • Urothelial Carcinoma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02929862
Other Study ID Numbers  ICMJE LYC-55716-1001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lycera Corp.
Study Sponsor  ICMJE Lycera Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lycera Corp.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP