A Phase I, Open-Label, Multi-center, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of GC33 Administered Weekly in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC)
A Phase I, Open-Label, Multi-center, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of GC33 Administered Weekly in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC)
This phase I trial is studying the safety and best dose of GC33 in patients with advanced or metastatic liver cancer.
This is a Phase I open-label dose escalation study of GC33 in patients with advanced or metastatic HCC. This study is designed to evaluate safety, tolerability, pharmacokinetics, and preliminary assessment of anti-tumor activity. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose has been established.
Inclusion Criteria:
Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form
Male or female ≥ 18 years old.
Life expectancy ≥ 3 months.
ECOG Performance Status of 0-1.
Histologically confirmed hepatocellular carcinoma (without fibrolamellar subtype).
Not a candidate for curative treatments.
Child-Pugh A or B.
Hematological, Biochemical and Organ Function:
Ability to provide a tumor tissue sample either by:
At least one measurable lesion based on Response Evaluation Criteria In Solid Tumors criteria.
(Extension Phase)
Signed written Institutional Review Board (IRB)/Ethical Committee (EC) approved informed consent form.
Male or female ≥ 18 years old.
Life expectancy ≥ 3 months.
ECOG Performance Status of 0-1.
Histologically confirmed hepatocellular carcinoma (without fibrolamellar subtype).
Not a candidate for curative treatments.
Child-Pugh A.
Hematological, Biochemical and Organ Function:
IHC confirmed GPC3-positive HCC tumor tissue. Tumor tissue sample may be provided by:
At least one measurable lesion based on Response Evaluation Criteria In Solid Tumors criteria.
Exclusion Criteria:
Child-Pugh C.
Pregnant or lactating women or women of child-bearing potential and men of childbearing potential not willing to use effective means of contraception.
Patients known to be positive for Human immunodeficiency virus infection.
Active infectious diseases requiring treatment except for hepatitis B and C.
Other malignancies within the last 5 years.
History of transplantation (organ, bone marrow transplantation,peripheral blood stem cell transplantation, etc.).
Patients with significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug.
Patients with brain metastases, other central nervous system or other psychiatric disease.
Patients who received major surgery, local therapy for HCC, chemotherapy, radiotherapy, hormone-therapy, immunotherapy, or another investigational drug within 4 weeks prior to Day 1.
Patients who received the following treatments within 2 weeks prior to Day1:
History of hypersensitivity to similar agents.
Patient is unable to comply with the requirements of the protocol and/or follow-up procedures.
(Extension Phase)
Child-Pugh B or C.
Pregnant or lactating women or women of child-bearing potential and men of childbearing potential not willing to use effective means of contraception.
Patients known to be positive for Human immunodeficiency virus infection.
Active infectious diseases requiring treatment except for hepatitis B and C.
Other malignancies within the last 5 years.
History of transplantation (organ, bone marrow transplantation, Peripheral blood stem cell transplantation, etc.).
Patients with significant concomitant disease determined by the investigator to be potentially aggravated by the investigational drug.
Patients with brain metastases, other central nervous system or other psychiatric disease.
Patients who received major surgery, local therapy for HCC, chemotherapy, radiotherapy, hormone-therapy, immunotherapy, or another investigational drug within 4 weeks prior to Day 1.
Patients who received the following treatments within 2 weeks prior to Day 1:
History of hypersensitivity to similar agents.
Patient is unable to comply with the requirements of the protocol and/or follow-up procedures.
IHC confirmed GPC3-negative HCC tumor tissue.