Actively Recruiting
Immuno-Oncology Drugs GLS-012 Alone & in Combination GLS-010 Treating With Advanced Patients Solid Tumors
Led by Guangzhou Gloria Biosciences Co., Ltd. · Updated on 2023-06-18
107
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I/II study to investigate the safety, tolerability, and preliminary efficacy of GLS-012 monotherapy and in combination with GLS-010 in subjects with advanced solid rumor after progression on standard treatment.
CONDITIONS
Official Title
Immuno-Oncology Drugs GLS-012 Alone & in Combination GLS-010 Treating With Advanced Patients Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who are willing to sign the informed consent form
- Aged 18 to 75 years, male or female
- Histologically confirmed diagnosis of a solid tumor
- Patients with advanced solid tumors after progression on standard treatment
- At least 1 measurable target lesion according to RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy more than 12 weeks
- Adequate organ and bone marrow function as shown by screening tests
- Women of childbearing potential must use highly effective contraception during the study and for at least 6 months after the last drug dose, and have a negative pregnancy test within 3 days before enrollment
You will not qualify if you...
- Patients with immune-related adverse events grade 3 or higher from prior immunotherapy, or whose last anti-tumor treatment side effects have not recovered to grade 1 or less, except certain thyroid or skin conditions
- Patients with primary or secondary immunodeficiency, or on long-term steroid or immunosuppressive therapy within 7 days before randomization
- Use of corticosteroids or immunosuppressants within 14 days before first study drug dose
- Known brain metastases
- Severe allergic reactions to protein or monoclonal antibody treatments in the past
- Other cancers diagnosed within 5 years except cured cervical carcinoma in situ or skin basal cell carcinoma
- Uncontrolled heart symptoms or diseases
- Known bleeding or clotting disorders
- Congenital or acquired immunodeficiency disorders including HIV or history of organ transplant
- Positive for hepatitis B surface antigen with high viral load or positive hepatitis C RNA
- Poor compliance or other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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