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

NCT05909436 | Recruiting Phase 1

• 1 other identifier: GLS-012-11
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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

Other Outcomes (1)

• Receptor occupancy (RO) of GLS-012 in the dose escalation stage of GLS-012 monotherapy

  Up to approximately 4.5 months

Study Arms (1)

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

EXPERIMENTAL

Drug: GLS-012; Drug: GLS-010

Interventions

GLS-012 DRUG

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.

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

GLS-010 DRUG

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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Gloria Biosciences Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

zimberelimab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 18, 2023
• Study Start: October 31, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 18, 2023

Record last verified: 2023-05

Locations

CN (1)