Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Cystadenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Cystic, Mucinous, and Serous

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Biliary Tract Cancer

Adenocarcinoma of the Appendix

All Drugs and Chemicals

Antibodies

Immunoglobulins

During the Dose Escalation Stage, patients will be treated with ZB131 at increasing dose levels, beginning with a starting dose level (DL0) of 3 mg/kg once weekly, up to a maximum dose level (DL3) of 15 mg/kg once weekly.

ZB131 will be administered once weekly by intravenous infusion with the weight at baseline used for mg/kg dose calculations.

ZB131

Ramesh Ramanathan, MD

This study is a first-in-human, Phase 1, open label, multicenter, dose escalation study with expansion at the RP2D, to evaluate the safety, tolerability, and preliminary efficacy of ZB131 in patients with solid tumors where prevalence of CSP expression is high. Approximately 12 to 24 patients will be enrolled in the Dose Escalation Stage; the total number of patients will depend on the dose level at which the RP2D is defined. Patients who meet the eligibility criteria during Screening will enter the treatment period. ZB131 will be given via IV every week. Patients will be treated until disease progression or unacceptable toxicities occur.

This study is a first-in-human, Phase 1, open label, multicenter, dose escalation study with expansion at the RP2D, to evaluate the safety, tolerability, and preliminary efficacy of ZB131 in patients with solid tumors where prevalence of CSP expression is high. Approximately 12 to 24 patients will be enrolled in the Dose Escalation Stage; the total number of patients will depend on the dose level at which the RP2D is defined. Patients who meet the eligibility criteria during Screening will enter the treatment period. ZB131 will be given via IV every week. Patients will be treated until disease progression or unacceptable toxicities occur.

Once the RP2D has been established, the Dose Expansion stage will begin to enroll subjects by cohort. For each expansion cohort, subjects will be enrolled in two stages. The first stage includes an evaluation of 12 patients. If 1 or more of 12 patients have a CR or PR, then accrual will continue until a total of 37 patients with measurable disease have been enrolled. Additional patients may be added to ensure 37 subjects with measurable disease are available for evaluation

A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody in Solid Tumors

A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A Cancer-Specific Plectin (CSP)-Targeting Functional Antibody in Solid Tumors That Are Likely to Express CSP

Determine maximum plasma concentration (Cmax)

ZielBio, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Immune System Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Stomach Neoplasms

Breast Neoplasms

Lymphoma

Leukemia

Hematologic Neoplasms

Liver Neoplasms

Brain Neoplasms

Hematologic Diseases

Stomach Cancer

Quality of Life

Lymphosarcoma

Brain Tumor, Childhood

Being referred to palliative care team before totally terminating their chemotherapy among adult participants.

Being referred to palliative care team when their last chemotherapy is ended among adult participants.

haven't been under the palliative care among adult participants

receiving the palliative care among pediatric participants

haven't received the palliative care among pediatric participants

Palliative Care Team provide a self-learning booklet, medical treatment and consultation about Advance Care Planning with chemotherapy by oncologist.

Early palliative care

Palliative Care Team provide a routine hospice care the same as other patients who doesn't participate this study after the chemotherapy is totally terminated

Routine hospice care

Young Ho Yun, MD-PhD

This study evaluates the change of quality of life, treatment decision and utilization of health care depending on the use of palliative care in advanced cancer patients by a prospective cohort study. Participants will be separated into different groups by their intentions for using palliative care. Every participant will carry out the questionnaire per 3 months. This cohort study will be ended a year after each participant enrolls. However, if the participant didn't survive during this study, the caregivers will be asked to fill out additional questionnaire after 3 months of the death.

Patients with advanced cancer report physical, emotional, social and economic problems that may be due to the cancer itself or its treatment. Previous studies have shown the benefit of early palliative care in oncology. However, many Korean patients tend to start palliative care late even in general hospital. Because of the late start of palliative care, the burden of medical expenses increases, on the other hand, the quality of life of terminally ill patients decrease.

In this study, the use of palliative care in advanced cancer patients will be evaluated by a prospective cohort study. The goals of this study are as follow:

First, the clinical, psycho-social, and cognitive factors affecting quality of life, decision making, and hospital utilization (palliative medical team medical treatment, hospice and medical care) of patients with advanced stage cancer will be investigated.

Second, this study will explore the effects of age-specific characteristics on quality of life and care.

Third, an index, which reflects age-specific characteristics and predicts the time and content of terminal care will be developed. Improvements on the quality of life and care of patients with advanced stage of cancer or metastatic cancer are expected to establish effective terminal care strategies through this study.

The patients' symptom and quality of life, choice of medical care, advance care planning and caregiver's burden of care will be evaluated every 3 months after confirming the willingness to use palliative care for cancer patients. 3 months after the death, a caregiver evaluation will be conducted and hospice use, medical expenses will be analyzed.

Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients

Change of Quality of Life, Treatment Decision and Utilization of Health Care Depending on the Use of Palliative Care in Adult and Pediatric Patients With Advanced Stage of Cancer: a Prospective Cohort Study

to measure quality of life of adult patients developed by European Organisation for Research and Treatment of Cancer for Palliative Care

Patients survival and POLST(Physician Order for Life-Sustaining Treatment) documentation whether patients survive during the study period and write POLST documentation (Since POLST has no legal form in Korea, it is based on the format of each institution.)

"Patient Health Questionnaire-9 items" is used as assessment tool to measure depression of both patients and their caregivers by completing the questionnaire.

"Decision Conflict Scale" is used as assessment tool to measure a level of decision conflict in treatment of both patients and their caregivers by completing the questionnaire.

to measure the awareness of patients' status of prognosis in both patients and caregivers through two questions in the questionnaire. The first question is about the idea of the possibility of curing the patient's disease and asks patients thought about whether treatment is available for cure and prolong survival. The second question concerns the life expectancy of the patient.

to measure the perceived holistic health status(physical, mental, social, spiritual and general) in both patients and caregivers. caregivers (The patient is asked to answer the perceived health status into five stages.)

To measure Daily functional skills in elderly only in 65-year or order patients.

Direct medical cost will be collected through National Health Insurance Corporation and Indirect cost will be collected by caregiver's questionnaire. In addition, "EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L)" tool will be included in the patient's questionnaire to measure the condition of patients at the same time.

In order to analyze the cost effectiveness, investigate the frequency of use of early palliative care programs, the use of life-sustaining treatment and hospicee, and the use of complementary and alternative medicine(CAM). CAM include Chinese medicine, aromatherapy, diet, and yoga, etc.

to assess the patient's awareness of advanced care planning and willingness to construct advanced care planning. The preference for palliative care is divided according to the life expectancy. Investigate the preference of palliative care in each case - if the life expectancy is within a year, within a few months, or within a few weeks.

To measure mental, social, spiritual quality of life of both patients and caregivers

"Pediatric Quality of Life Inventory(Peds QL)" will be used as assessment tool for QOL among pediatric patients.

Seoul National University Bundang Hospital

National Cancer Center, Korea

Kyunghee University Medical Center

Severance Hospital

Gyeongsang National University Hospital

Chungnam National University Hospital

Chonbuk National University Hospital

Ewha Womans University Mokdong Hospital

Daegu Fatima Hospital

Chonnam National University Hospital

Keimyung University Dongsan Medical Center

Hallym University Medical Center

Asan Medical Center

National Evidence-Based Healthcare Collaborating Agency

National Institute of Health, Korea

National Clinical Research Coordination Center, Seoul, Korea

Ulsan University Hospital

Seoul National University Hospital

Clinical Professor

Symptoms and General Pathology

Recurrence

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Irinotecan

Gemcitabine

Leucovorin

Fluorouracil

Cisplatin

Oxaliplatin

Levoleucovorin

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Folinic Acid

Folate

Vitamin B9

D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

Oxaliplatin,5FU, leucovorin

irinotecan,5FU, leucovorin

In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized phase 2 trial.

1. brief enrollment criteria

   * histological confirmed
   * refractory to first line gemcitabine plus cisplatin
   * fit for chemotherapy
2. treatment arms A. mFOLFOX D1 oxaliplatin 100mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks

   B. mFOLFIRI D1 Irinotecan 150mg/m2 over 2hr Leucovorin 100mg/m2 over 2hr 5FU 2400mg/m2 over 46hr Every 2 weeks
3. randomization - stratified by tumor site and performance status

mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line

A Randomized Phase II Study of mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line Gemcitabine Plus Cisplatin

at 6 months from intervention treatment, overall survival rate

complete response, partial response, stable disease

from treatment start to progression or any cause of death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody in Solid Tumors	NCT05074472	Solid Tumor, Ad... Pancreatic Duct... Ovarian Serous ... Biliary Cancer ... Ovarian Serous ...	ZB131	18 Years -	ZielBio, Inc.
Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients	NCT03222258	Stage IV Breast... Stage IV Pancre... Stage IV Colon ... Stage IV Gastri... Stage IV Lung C... Stage IV Liver ... Malignant Hemat... Biliary Cancer ... Pediatric Leuke... Pediatric Lymph... Pediatric Brain... Pediatric Solid...	Early palliativ... Routine hospice...	-	Seoul National University Hospital
mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line	NCT03464968	Biliary Cancer ...	Oxaliplatin,5FU... irinotecan,5FU,...	20 Years -	Seoul National University Bundang Hospital
A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody in Solid Tumors	NCT05074472	Solid Tumor, Ad... Pancreatic Duct... Ovarian Serous ... Biliary Cancer ... Ovarian Serous ...	ZB131	18 Years -	ZielBio, Inc.
Prospective Cohort Study Depending on the Use of Palliative Care for Advanced Stage of Cancer Patients	NCT03222258	Stage IV Breast... Stage IV Pancre... Stage IV Colon ... Stage IV Gastri... Stage IV Lung C... Stage IV Liver ... Malignant Hemat... Biliary Cancer ... Pediatric Leuke... Pediatric Lymph... Pediatric Brain... Pediatric Solid...	Early palliativ... Routine hospice...	-	Seoul National University Hospital
A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody in Solid Tumors	NCT05074472	Solid Tumor, Ad... Pancreatic Duct... Ovarian Serous ... Biliary Cancer ... Ovarian Serous ...	ZB131	18 Years -	ZielBio, Inc.
A Phase 1/2, First-in-Human, Open Label, Dose Escalation Study Of A CSP Targeting Functional Antibody in Solid Tumors	NCT05074472	Solid Tumor, Ad... Pancreatic Duct... Ovarian Serous ... Biliary Cancer ... Ovarian Serous ...	ZB131	18 Years -	ZielBio, Inc.

Spots Global Cancer Trial Database for biliary cancer metastatic