A Multicenter, Open-label, Phase 1a Study of HC 5404-FU in Subjects with Selected, Advanced Solid Tumors.
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: HiberCell, Inc.
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: This is a first-in-human study designed to establish the maximum tolerated dose, and to evaluate the safety and tolerability of oral drug HC-5404-FU in subjects with advanced solid tumors. Specific tumor types evaluated in this study are; renal cell carcinoma, gastric cancer, metastatic breast cancer, or small-cell lung cancer. HC-5404-FU is highly selective for protein kinase RNA-like endoplasmic reticulum kinase (PERK) and acts as a PERK inhibitor. PERK plays an important role in tumor growth and new blood vessel development, therefore interfering with PERK function could potentially lead to tumor growth inhibition.
- Have a signed informed consent form (ICF) prior to any study-specific procedures or treatment
- Be ≥18 years of age (male or female) at the time of consent
- Have 1 of the following histologically or cytologically confirmed tumor types with qualifying characteristics, and have received a minimum of 3 (and no more than 5) lines of prior therapy for metastatic (Stage IV) disease:
a. RCC (renal cell carcinoma – clear cell or papillary)
b. GC (gastric adenocarcinoma)
c. Human epidermal growth factor receptor positive (HER2+) MBC
(metastatic breast cancer)
d. SCLC (small cell lung cancer)
- Have at least 1 radiologically measurable lesion as per RECIST v1.1.
- Two biopsies will be necessary: at baseline (within 30 days prior to first dose) and within 7 days after Cycle 3/Day 1. Newly obtained biopsy specimens are preferred to archived samples, and formalin-fixed, paraffin-embedded block specimens are preferred to slides. In the event a fresh pre-treatment biopsy is not able to be provided, the most recent archival biopsy must be provided in its place.
- ECOG Status of 0 or 1.
- Have life expectancy of 3 months or greater as determined by the treating physician.
- Have adequate organ function within 15 days prior to first administration of dose.
- Be willing and have the ability to comply with scheduled visits (including geographical proximity), treatment plans, laboratory tests, and other study procedures.
- Additional criteria may apply and will be discussed in further detail with the physician.
- Subject is currently pregnant, planning to become pregnant, or breastfeeding
- Had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first dose of study treatment or who has not recovered from adverse reactions due to a previously administered agent or major surgery.
- Is currently participating in a clinical trial and is receiving treatment using an investigational drug or investigational device, or has received treatment using an investigational therapy within 4 weeks prior to first dose.
- Has a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- Has known history of active tuberculosis, history of HIV (HIV 1/2 antibodies), has known active Hepatitis B (anti-hepatitis B surface antibody, anti-hepatitis B core antibody, hepatitis B surface antigen [HBsAg]) or Hepatitis C (hepatitis C antibody) infection, history of clinically severe autoimmune disease, or a history of organ transplant.
- Has been diagnosed with severe acute respiratory syndrome coronavirus (SARS-CoV)-2 infection and/or is seropositive for (SARS-CoV)-2 antibodies, as per the local guidelines at screening and is positive by 7 days prior to the first dose of study treatment.
- Has insulin-dependent (Type I) diabetes or poorly controlled Type II diabetes (per clinical discretion).
- Has known additional malignancy that is progressing or required active treatment within previous 5 years. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy, superficial bladder cancer, or in situ cervical cancer. Subjects with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
- Has known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of disease progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using systemic steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- Has a history of interstitial lung disease, pneumonitis within 12 months prior to screening or current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or ongoing clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome, symptomatic or uncontrolled arrhythmia, congestive heart failure, baseline ECG abnormalities, including, but not limited to, QTc prolongation (prolonged QTcF defined as ≥450 msec) or any Class III or IV cardiac disease as defined by the New York Heart Association Functional Classification.
- Has overt or latent disorders of the exocrine pancreas (such as acute or chronicpancreatitis of any etiology) or chronic (including autoimmune) gastrointestinal disorders such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, lupus, scleroderma, Sjogren’s syndrome, and polyarteritis nodosa.
- Has a known psychiatric or substance abuse disorder(s) that would interfere with informed consent or cooperation with the requirements of the trial.
- Additional exclusion criteria may apply and will be discussed with physician.
Lisa Wahowske, RN, BSN, OCN
Principal Investigator: Brian Martinson, PhD
Study Sponsor: The Laura and John Arnold Foundation
Purpose of study:
The Flu-PRO Study survey is being done by The Laura and John Arnold Foundation to explore ways to help patients manage flu symptoms following a healthcare visit. The survey is being offered online to people experiencing respiratory symptoms. If you have received a survey invitation and would like to participate, please contact the Center for Evaluation & Survey Research (CESR).
- Currently feeling sick from recent respiratory illness
- Over 18 years old
- Have access to a computer/internet
- Under 18 years old
- Have no recent symptoms due to respiratory illness
CESR Flu-PRO Study Recruitment line