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

Phase 1

Recruiting

• Conditions: Solid Tumor
• Interventions: Drug: GLS-012; Drug: GLS-010

• Registration Number: NCT05909436
• Lead Sponsor: Guangzhou Gloria Biosciences Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-31
• Status Verified: 2023-05
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-06-11
• Last Update Submitted: 2023-06-11
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 107

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010	GLS-010	-
Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010	GLS-012	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Overall survival (OS)	Up to approximately 24 months
Time to response (TTR)	Up to approximately 24 months
Duration of response (DOR)	Up to approximately 24 months
Progression free survival (PFS)	Up to approximately 24 months

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, China