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.
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;
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.
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.
Use of corticosteroids or other immunosuppressants for systemic treatment within 14 days before the first study drug administration;
Known central nervous system (CNS) metastases;
Single group
GLS-012
DrugIn 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.
GLS-010
DrugIn 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.
Number of Participants with a Dose-Limiting Toxicity (DLT) and MTD in the dose escalation stage
Number of participants with treatment-related adverse events of GLS-012 monotherapy and in combination with GLS-010 in the expansion stage as assessed by CTCAE V5.0
Maximum plasma concentration (Cmax) of GLS-012 monotherapy and in combination with GLS-010
Elimination half-life (T1/2) of GLS-012 monotherapy and in combination with GLS-010
Objective response rate (ORR)
Disease control rate (DCR)
Receptor occupancy (RO) of GLS-012 in the dose escalation stage of GLS-012 monotherapy
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