Immuno-Oncology Drugs GLS-012 Alone & in Combination GLS-010 Treating With Advanced Patients Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010
|
Drug: 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 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.
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with a Dose-Limiting Toxicity (DLT) and MTD in the dose escalation stage [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 [Up to approximately 24 months]
Secondary Outcome Measures
- Maximum plasma concentration (Cmax) of GLS-012 monotherapy and in combination with GLS-010 [Up to approximately 4.5 months]
- Elimination half-life (T1/2) of GLS-012 monotherapy and in combination with GLS-010 [Up to approximately 4.5 months]
- Objective response rate (ORR) [Up to approximately 24 months]
- Disease control rate (DCR) [Up to approximately 24 months]
- Preliminary anti-tumor activity: Duration of response (DOR), time to response (TTR), progression free survival (PFS), overall survival (OS) [Up to approximately 24 months]
- Duration of response (DOR) [Up to approximately 24 months]
- Time to response (TTR) [Up to approximately 24 months]
- Progression free survival (PFS) [Up to approximately 24 months]
- Overall survival (OS) [Up to approximately 24 months]
Other Outcome Measures
- Receptor occupancy (RO) of GLS-012 in the dose escalation stage of GLS-012 monotherapy [Up to approximately 4.5 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who are willing to sign the informed consent form;
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Aged 18-75 years, male or female;
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Histologically confirmed diagnosis of a solid tumor;
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Patients with advanced solid tumors after progression on standard treatment;
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Subjects must have at least 1 measurable target lesion according to RECIST version 1.1；
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Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1；
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Life expectancy more than 12 weeks;
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Adequate organ function and bone marrow function as indicated by the screening assessments in the screening period;
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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:
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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.
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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.
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Use of corticosteroids or other immunosuppressants for systemic treatment within 14 days before the first study drug administration;
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Known central nervous system (CNS) metastases;
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Patients with severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies in the past.
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Patients with other malignant tumors within 5 years before screening, except cured cervical carcinoma in situ and cured skin basal cell carcinoma.
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Cardiac clinical symptoms or diseases that are not well controlled.
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Known hereditary or acquired bleeding and thrombosis tendency.
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Patients with congenital or acquired immunodeficiency disorders (such as HIV-infection), or a history of organ transplantation.
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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;
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Patients with poor compliance or other conditions that are not suitable to participate in the clinical trial, as considered by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Cancer Hospital | Beijing | China |
Sponsors and Collaborators
- Guangzhou Gloria Biosciences Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GLS-012-11