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Trial Title:
Immuno-Oncology Drugs GLS-012 Alone & in Combination GLS-010 Treating With Advanced Patients Solid Tumors
NCT ID:
NCT05909436
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GLS-012
Description:
In the dose escalation stage of GLS-012 monotherapy, RP2D will be determined. All
subjects will receive GLS-012 intravenously Q3W.
In the expansion stage of GLS-012 monotherapy, subjects will receive up to 17 doses of
GLS-012 at the RP2D administered Q3W.
In the dose escalation stage of GLS-012 combination with GLS-010, RP2D of GLS-012 in
combination with a fixed-dose GLS-010 will be determined. All subjects will receive
GLS-012 and GLS-010 intravenously Q3W.
In the expansion stage of GLS-012 combination with GLS-010, subjects will receive up to
35 doses of GLS-012 at the RP2D and GLS-010 at a fixed dose administered Q3W.
Arm group label:
Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010
Intervention type:
Drug
Intervention name:
GLS-010
Description:
In the dose escalation stage of GLS-012 combination with GLS-010, RP2D of GLS-012 in
combination with a fixed-dose GLS-010 will be determined. All subjects will receive
GLS-012 and GLS-010 intravenously Q3W.
In the expansion stage of GLS-012 combination with GLS-010, subjects will receive up to
35 doses of GLS-012 at the RP2D and GLS-010 at a fixed dose administered Q3W.
Arm group label:
Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients who are willing to sign the informed consent form;
2. Aged 18-75 years, male or female;
3. Histologically confirmed diagnosis of a solid tumor;
4. Patients with advanced solid tumors after progression on standard treatment;
5. Subjects must have at least 1 measurable target lesion according to RECIST version
1.1；
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1；
7. Life expectancy more than 12 weeks;
8. Adequate organ function and bone marrow function as indicated by the screening
assessments in the screening period;
9. Women of childbearing potential must use highly effective contraception during the
study period and at least 6 months after the last study drug administration, and
must have a negative blood pregnancy test within 3 days before study enrollment.
Exclusion Criteria:
1. Patients with irAEs of grade ≥ 3 in the previous immunotherapy, and the AEs of the
last anti-tumor treatment have not recovered to grade ≤ 1, except for
hypothyroidism/hyperthyroidism and dermatitis that have recovered to grade ≤ 2, and
AEs with no safety risks judged by the investigators, for example, alopecia.
2. Patients with primary or secondary immunodeficiency, or patients who are receiving
long-term systemic steroid therapy or any other form of immunosuppressive therapy
within 7 days before randomization.
3. Use of corticosteroids or other immunosuppressants for systemic treatment within 14
days before the first study drug administration;
4. Known central nervous system (CNS) metastases;
5. Patients with severe hypersensitivity to macromolecular protein
preparations/monoclonal antibodies in the past.
6. Patients with other malignant tumors within 5 years before screening, except cured
cervical carcinoma in situ and cured skin basal cell carcinoma.
7. Cardiac clinical symptoms or diseases that are not well controlled.
8. Known hereditary or acquired bleeding and thrombosis tendency.
9. Patients with congenital or acquired immunodeficiency disorders (such as
HIV-infection), or a history of organ transplantation.
10. Patients complying with any of hepatitis B surface antigen (HBsAg) positive and
HBV-DNA copies being more than 2500 copies/ml (or 500 IU/ml); or positive HCV-RNA;
11. Patients with poor compliance or other conditions that are not suitable to
participate in the clinical trial, as considered by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Guo, MD
Phone:
+86-010-88121122
Email:
guoj307@126.com
Start date:
October 31, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
Guangzhou Gloria Biosciences Co., Ltd.
Agency class:
Industry
Source:
Guangzhou Gloria Biosciences Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05909436
