Treatment for advanced solid tumors using GLS-012 and GLS-010

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)

This study is testing a new treatment using GLS-012 alone and with GLS-010 to see if it can help adults with advanced solid tumors that haven't improved with standard treatments.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 107 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangzhou Gloria Biosciences Co., Ltd. (industry)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT05909436 on ClinicalTrials.gov

What this trial studies

This study investigates the safety, tolerability, and preliminary efficacy of GLS-012 as a standalone treatment and in combination with GLS-010 for patients with advanced solid tumors who have not responded to standard therapies. It is designed for individuals aged 18-75 with histologically confirmed solid tumors and aims to assess the effectiveness of these immuno-oncology drugs. Participants will be monitored for measurable target lesions and overall health status throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced solid tumors that have progressed after standard treatment.

Not a fit: Patients with severe immune-related adverse events from previous immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide new options for patients with advanced solid tumors who have exhausted standard treatment options.

How similar studies have performed: Other studies have shown promise with similar immuno-oncology approaches, suggesting potential for success in this trial.

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.

Where this trial is running

Beijing

• Beijing Cancer Hospital — Beijing, China (RECRUITING)

Conditions: Solid Tumor