NCT05909436 Immuno-Oncology Drugs GLS-012 Alone & in Combination GLS-010 Treating With Advanced Patients Solid Tumors
| NCT ID | NCT05909436 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Guangzhou Gloria Biosciences Co., Ltd. |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 107 participants |
| Start Date | 2022-10-31 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
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