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CancerPhase 1/2NCT02929862

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

A Phase 1/2 study testing LYC-55716 in people with Cancer, run by Lycera Corp. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
LYC-55716
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
20 sitesUnited States
Study dates
Dec 2016to 31 May 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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)

Who cannot join

  • 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:
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  • NSCLC
  • Gastric, Esophageal, and G-E Junction Adenocarcinoma
  • SCCHN
  • Ovarian Carcinoma
  • Renal Cell Carcinoma
  • Urothelial Carcinoma

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Lycera Investigational Site

    Atlanta, Georgia, 30322

  • Lycera Investigational Site

    Augusta, Georgia, 30912

  • Lycera Investigational Site

    Charlottesville, Virginia, 22908

  • Lycera Investigational Site

    Chicago, Illinois, 60611

  • Lycera Investigational Site

    Dallas, Texas, 75230

  • Lycera Investigational Site

    Durham, North Carolina, 27710

  • Lycera Investigational Site

    Fairfax, Virginia, 22031

  • Lycera Investigational Site

    Greenville, South Carolina, 29605

  • Lycera Investigational Site

    Huntsville, Alabama, 35805

  • Lycera Investigational Site

    Nashville, Tennessee, 37203

  • Lycera Investigational Site

    New York, New York, 10016

  • Lycera Investigational Site

    Oklahoma City, Oklahoma, 73104

  • Lycera Investigational Site

    Omaha, Nebraska, 68130

  • Lycera Investigational Site

    Philadelphia, Pennsylvania, 19111

  • Lycera Investigational Site

    Portland, Oregon, 97213

  • Lycera Investigational Site

    Sacramento, California, 95817

  • Lycera Investigational Site

    Saint Cloud, Minnesota, 56303

  • Lycera Investigational Site

    San Antonio, Texas, 78229

  • Lycera Investigational Site

    Sarasota, Florida, 34232

  • Lycera Investigational Site

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

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

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.

Read the 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
Being tested
LYC-55716
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LYC-55716Drug

    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 groups in NCT02929862
Study groupRoleWhat they receive
Single Agent 55716ExperimentalNot described
Receives: Drug: LYC-55716

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess Tumor Activity

    Evaluated according to RECIST v1.1

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion31 May 2019
  4. Study completion31 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02929862
Sponsor's protocol ID
LYC-55716-1001
Status last verified
May 2018
First submitted
5 Oct 2016
Last updated
25 Sep 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LYC-55716 in people with Cancer, run by Lycera Corp. at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess Tumor Activity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02929862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.

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