Last updated: June 11, 2023
Sponsor: Guangzhou Gloria Biosciences Co., Ltd.
Overall Status: Active - Recruiting
Phase
1/2
Condition
Neuroblastoma
Neoplasms
Treatment
GLS-010
GLS-012
Clinical Study ID
NCT05909436
GLS-012-11
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients who are willing to sign the informed consent form;
- Aged 18-75 years, male or female;
- Histologically confirmed diagnosis of a solid tumor;
- Patients with advanced solid tumors after progression on standard treatment;
- Subjects must have 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 function and bone marrow function as indicated by the screeningassessments in the screening period;
- Women of childbearing potential must use highly effective contraception during thestudy period and at least 6 months after the last study drug administration, and musthave a negative blood pregnancy test within 3 days before study enrollment.
Exclusion
Exclusion Criteria:
- Patients with irAEs of grade ≥ 3 in the previous immunotherapy, and the AEs of thelast anti-tumor treatment have not recovered to grade ≤ 1, except forhypothyroidism/hyperthyroidism and dermatitis that have recovered to grade ≤ 2, andAEs with no safety risks judged by the investigators, for example, alopecia.
- Patients with primary or secondary immunodeficiency, or patients who are receivinglong-term systemic steroid therapy or any other form of immunosuppressive therapywithin 7 days before randomization.
- Use of corticosteroids or other immunosuppressants for systemic treatment within 14days before the first study drug administration;
- Known central nervous system (CNS) metastases;
- Patients with severe hypersensitivity to macromolecular proteinpreparations/monoclonal antibodies in the past.
- Patients with other malignant tumors within 5 years before screening, except curedcervical carcinoma in situ and cured skin basal cell carcinoma.
- Cardiac clinical symptoms or diseases that are not well controlled.
- Known hereditary or acquired bleeding and thrombosis tendency.
- Patients with congenital or acquired immunodeficiency disorders (such asHIV-infection), or a history of organ transplantation.
- Patients complying with any of hepatitis B surface antigen (HBsAg) positive andHBV-DNA copies being more than 2500 copies/ml (or 500 IU/ml); or positive HCV-RNA;
- Patients with poor compliance or other conditions that are not suitable to participatein the clinical trial, as considered by the investigator.
Study Design
Total Participants: 107
Treatment Group(s): 2
Primary Treatment: GLS-010
Phase: 1/2
Study Start date:
October 31, 2022
Estimated Completion Date:
December 31, 2026
Connect with a study center
Beijing Cancer Hospital
Beijing,
ChinaActive - Recruiting
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