About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- GLS-012
- GLS-010