Immuno-Oncology Drugs GLS-012 Alone & in Combination GLS-010 Treating With Advanced Patients Solid Tumors

Официальное название

A Phase I/II Study Evaluating the Safety, Tolerability and Preliminary Efficacy of GLS-012 Monotherapy and in Combination With GLS-010 in Patients With Advanced Solid Tumors After Progression on Standard Treatment (Triumph-01)

Обзор

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.

Вмешательства

• Препарат GLS-012
  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
• Препарат GLS-010
  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.

Первичные конечные точки

• Number of Participants with a Dose-Limiting Toxicity (DLT) and MTD in the dose escalation stage [Срок оценки: Up to 21 days after the first dose]
• 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 [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (9)

• Maximum plasma concentration (Cmax) of GLS-012 monotherapy and in combination with GLS-010 [Срок оценки: Up to approximately 4.5 months]
• Elimination half-life (T1/2) of GLS-012 monotherapy and in combination with GLS-010 [Срок оценки: Up to approximately 4.5 months]
• Objective response rate (ORR) [Срок оценки: Up to approximately 24 months]
• Disease control rate (DCR) [Срок оценки: Up to approximately 24 months]
• Preliminary anti-tumor activity: Duration of response (DOR), time to response (TTR), progression free survival (PFS), overall survival (OS) [Срок оценки: Up to approximately 24 months]
• Duration of response (DOR) [Срок оценки: Up to approximately 24 months]
• Time to response (TTR) [Срок оценки: Up to approximately 24 months]
• Progression free survival (PFS) [Срок оценки: Up to approximately 24 months]
• Overall survival (OS) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• 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 screening assessments in the screening period;
• 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.

Критерии исключения

• 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;
• Patients with severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies in the past.
• Patients with other malignant tumors within 5 years before screening, except cured cervical 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 as HIV-infection), or a history of organ transplantation.
• 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;
• Patients with poor compliance or other conditions that are not suitable to participate in the clinical trial, as considered by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT05909436 · GLS-012-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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