Clinical Trials List
Protocol NumberOBI-866-001
2020-09-20 - 2024-02-22
Phase I
Recruiting2
ICD-10C71.0
Malignant neoplasm of cerebrum, except lobes and ventricles
ICD-10C56.9
Malignant neoplasm of unspecified ovary
ICD-10C64.9
Malignant neoplasm of unspecified kidney, except renal pelvis
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C25.9
Malignant neoplasm of pancreas, unspecified
ICD-10C50.919
Malignant neoplasm of unspecified site of unspecified female breast
ICD-9183.0
Malignant neoplasm of ovary
ICD-9157.9
Malignant neoplasm of pancreas, part unspecified
ICD-9189.0
Malignant neoplasm of kidney, except pelvis
ICD-9191.0
Malignant neoplasm of cerebrum, except lobes and ventricles
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
ICD-9174.9
Malignant neoplasm of female breast, unspecified
A Phase I, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of OBI-866/OBI-821, a Novel Anti-Stage-Specific Embryonic Antigen-4 (SSEA-4) Active Immunotherapy, in Patients with Advanced/Metastatic Cancers of the Ovary, Kidney, Brain, Pancreas, Breast or Lung
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Trial Applicant
OBI PHARMA, INC.
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Sponsor
-
Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 黃子權 Division of Hematology & Oncology
- 彭忠衎 Division of Hematology & Oncology
- 沈志浩 Division of Hematology & Oncology
- 余慕賢 Division of Hematology & Oncology
- 陳宇欽 Division of Hematology & Oncology
- 陳佳宏 Division of Hematology & Oncology
- 簡志峯 Division of Hematology & Oncology
- 孟繁俊 Division of Hematology & Oncology
- 何景良 Division of Hematology & Oncology
- 張平穎 Division of Hematology & Oncology
- 吳宜穎 Division of Hematology & Oncology
- 張山岳 Division of Hematology & Oncology
- 蔡文銓 Division of Hematology & Oncology
- 戴明燊 Division of Hematology & Oncology
- 葉人華 Division of Hematology & Oncology
- 蔡鎮良 Division of Hematology & Oncology
- 王毓淇 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ching-Chan Lin Division of Hematology & Oncology
- Ming-Hung Tsai Division of Hematology & Oncology
- Su-Peng Yeh Division of Hematology & Oncology
- Chang-Fang Chiu Division of Hematology & Oncology
- Chih-Yen Tu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
1 Recruiting
Condition/Disease
Cancers of the Ovary, Kidney, Brain, Pancreas, Breast or Lung
Objectives
Primary objective:
To evaluate the safety and tolerability of OBI-866/OBI-821 in patients with
advanced/metastatic cancers of the ovary, kidney, brain, pancreas, breast or lung
Secondary objectives:
1. To assess the frequency and magnitude of humoral immune responses for anti-SSEA-4 IgG
and IgM following the subcutaneous administration of OBI-866/OBI-821
2. To determine the preliminary efficacy of OBI-866/OBI-821 as assessed by tumor response
Test Drug
OBI-866 (SSEA-4) / OBI-821 (adjuvant)
Active Ingredient
OBI-821 (adjuvant)
OBI-866 (SSEA4)
OBI-866 (SSEA4)
Dosage Form
liquid
lyophilized powder
lyophilized powder
Dosage
37.5 μg
150 μg
150 μg
Endpoints
Primary endpoints:
(1) To evaluate the safety profile of OBI-866/OBI-821 by following parameters:
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Local injection site reaction
Changes in laboratory tests, including hematology, serum biochemistry, coagulation,
and urinalysis
Changes in vital signs
Changes in electrocardiograms (ECGs)
Changes in physical examination (PE)
(2) To determine the tolerability of OBI-866/OBI-821 by dose-limiting toxicities (DLTs) as
assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse
Events (CTCAE) version 5.0
(1) To evaluate the safety profile of OBI-866/OBI-821 by following parameters:
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Local injection site reaction
Changes in laboratory tests, including hematology, serum biochemistry, coagulation,
and urinalysis
Changes in vital signs
Changes in electrocardiograms (ECGs)
Changes in physical examination (PE)
(2) To determine the tolerability of OBI-866/OBI-821 by dose-limiting toxicities (DLTs) as
assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse
Events (CTCAE) version 5.0
Inclution Criteria
(1) Subjects are at least 20 years old at screening (inclusive).
(2) Subjects with histologically or cytologically confirmed advanced/metastatic cancers of the
ovary, kidney, brain, pancreas, breast or lung that failed to respond to all available
therapies, or physicians have determined that such established therapy is not sufficiently
efficacious, or subjects have declined to receive the standard-of-care therapy per local
practice
(3) Subject with at least one primary tumor lesion that can be assessed by RECIST version 1.1
criteria
(4) Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at the
screening visit
(5) Subjects must have a life expectancy of more than 3 months.
(6) Subjects must have adequate organ functions as defined below:
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× upper
limit of normal (ULN); AST and ALT ≤ 5× ULN (with underlying liver
metastasis)
Total bilirubin ≤ 1.5× ULN
Serum creatinine ≤ 1.5× ULN
Absolute neutrophil count (ANC) ≥ 1,200/µL
Platelets ≥ 75,000/µL
(7) Both male and female subjects with child-bearing potential must agree to apply acceptable
contraceptive methods during the study period (e.g., barrier contraceptives [male condom,
female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants,
injectables, combination oral contraceptives, transdermal patches, or contraceptive rings],
and intrauterine devices).
(8) Subjects without childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in study. Postmenopausal is defined as no menses for at least 12 months
without an alternative medical cause.
(9) Subjects with ability to understand and are willing to sign written informed consent
document according to institutional guidelines
(10) Subjects willing and able to communicate well with the investigator and comply with all
study visits and procedures
(2) Subjects with histologically or cytologically confirmed advanced/metastatic cancers of the
ovary, kidney, brain, pancreas, breast or lung that failed to respond to all available
therapies, or physicians have determined that such established therapy is not sufficiently
efficacious, or subjects have declined to receive the standard-of-care therapy per local
practice
(3) Subject with at least one primary tumor lesion that can be assessed by RECIST version 1.1
criteria
(4) Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at the
screening visit
(5) Subjects must have a life expectancy of more than 3 months.
(6) Subjects must have adequate organ functions as defined below:
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× upper
limit of normal (ULN); AST and ALT ≤ 5× ULN (with underlying liver
metastasis)
Total bilirubin ≤ 1.5× ULN
Serum creatinine ≤ 1.5× ULN
Absolute neutrophil count (ANC) ≥ 1,200/µL
Platelets ≥ 75,000/µL
(7) Both male and female subjects with child-bearing potential must agree to apply acceptable
contraceptive methods during the study period (e.g., barrier contraceptives [male condom,
female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants,
injectables, combination oral contraceptives, transdermal patches, or contraceptive rings],
and intrauterine devices).
(8) Subjects without childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in study. Postmenopausal is defined as no menses for at least 12 months
without an alternative medical cause.
(9) Subjects with ability to understand and are willing to sign written informed consent
document according to institutional guidelines
(10) Subjects willing and able to communicate well with the investigator and comply with all
study visits and procedures
Exclusion Criteria
Subjects meet any of the following criteria will not be enrolled in this study:
(1) Subjects who have untreated or unstable central nervous system (CNS) metastases (except
for brain tumor). Whether subjects with treated and stably controlled CNS metastases are
eligible will be judged by the investigator.
(2) Subjects who have history of splenectomy
(3) Subjects with human immunodeficiency virus (HIV) infection, active hepatitis B virus
(HBV) infection, or active hepatitis C virus (HCV) infection
(4) Subjects with a positive test result for SARS-CoV-2 by standard reverse transcription
polymerase chain reaction (RT-PCR) at screening
(5) Subjects with any autoimmune or other disorders requiring intravenous (iv)/oral steroids or
immunosuppressive or immunomodulatory therapies within 4 weeks prior to the first dose
of OBI-866/OBI-821. Single systemic acute or prophylactic use of steroids is allowed.
(6) Subjects who participated in the study with any other investigational or non-registered
product (including drug, vaccine, and device) within 4 weeks prior to the first dose of
OBI-866/OBI-821
(7) Subjects with any known unstable inter-current illness including ongoing or active
infections, symptomatic congestive heart failure (New York Heart Association [NYHA]
class 3 and 4), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements
(8) Subjects who have received major surgery, radiation therapy, or systemic anti-cancer
therapy within 2 weeks prior to the first dose of OBI-866/OBI-821. All toxicities attributed
to prior anti-cancer therapy must have resolved or returned to baseline before
administration of study drug. Subjects with prior treatment-related toxicities which are not
expected to resolve and result in long-lasting sequelae are permitted to enroll.
(9) Subjects who have not recovered from AEs due to previous treatment as judged by theinvestigator
(10) Subjects who have received vaccination within 4 weeks prior to the first dose of
OBI-866/OBI-821
(11) Subjects with known or suspected hypersensitivity to OBI-866/OBI-821 or its excipients
(12) Female subjects who are pregnant or breast-feeding at screening or plan to be pregnant or breast-feeding during the study period.
(13) Subjects with any conditions that the investigator deems to be unsuitable for participating the study.
(1) Subjects who have untreated or unstable central nervous system (CNS) metastases (except
for brain tumor). Whether subjects with treated and stably controlled CNS metastases are
eligible will be judged by the investigator.
(2) Subjects who have history of splenectomy
(3) Subjects with human immunodeficiency virus (HIV) infection, active hepatitis B virus
(HBV) infection, or active hepatitis C virus (HCV) infection
(4) Subjects with a positive test result for SARS-CoV-2 by standard reverse transcription
polymerase chain reaction (RT-PCR) at screening
(5) Subjects with any autoimmune or other disorders requiring intravenous (iv)/oral steroids or
immunosuppressive or immunomodulatory therapies within 4 weeks prior to the first dose
of OBI-866/OBI-821. Single systemic acute or prophylactic use of steroids is allowed.
(6) Subjects who participated in the study with any other investigational or non-registered
product (including drug, vaccine, and device) within 4 weeks prior to the first dose of
OBI-866/OBI-821
(7) Subjects with any known unstable inter-current illness including ongoing or active
infections, symptomatic congestive heart failure (New York Heart Association [NYHA]
class 3 and 4), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements
(8) Subjects who have received major surgery, radiation therapy, or systemic anti-cancer
therapy within 2 weeks prior to the first dose of OBI-866/OBI-821. All toxicities attributed
to prior anti-cancer therapy must have resolved or returned to baseline before
administration of study drug. Subjects with prior treatment-related toxicities which are not
expected to resolve and result in long-lasting sequelae are permitted to enroll.
(9) Subjects who have not recovered from AEs due to previous treatment as judged by theinvestigator
(10) Subjects who have received vaccination within 4 weeks prior to the first dose of
OBI-866/OBI-821
(11) Subjects with known or suspected hypersensitivity to OBI-866/OBI-821 or its excipients
(12) Female subjects who are pregnant or breast-feeding at screening or plan to be pregnant or breast-feeding during the study period.
(13) Subjects with any conditions that the investigator deems to be unsuitable for participating the study.
The Estimated Number of Participants
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Taiwan
16 participants
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Global
16 participants
