Trials Sponsors Conditions Drugs Pricing

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
+4 more secondary outcomes

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-012Drug: GLS-010

Interventions

GLS-012Drug

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-010Drug

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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;

Sponsors & Collaborators

Guangzhou Gloria Biosciences Co., Ltd.
Industrylead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

Jun Guo, MDCONTACT+86-010-88121122 guoj307@126.com

MeSH Terms

Interventions

zimberelimab

Study Design

Study Type: interventional
Phase: phase 1 2
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

Actual (reported)

Primary Completion

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Other Outcomes (1)

Study Arms (1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Other Outcomes (1)

Study Arms (1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations