A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients with Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)

Conditions

Upper Gastrointestinal Tract Cancer, Advanced Upper Gastrointestinal Tract Malignancies, Gastrointestinal Tract Malignancies

Brief summary

The Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and any Clinically meaningful trends in safety parameters [Time Frame: Up to 18 months], Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and assessed by the investigator [Time Frame: Up to 18 months]

Detailed description

Objective Response Rate (ORR) as measured by PD-L1 Expression Level [Time Frame: Up to 18 months], Overall survival (OS) [Time Frame: From date of first dose until the date of death due to any cause (approximately 18 months)], Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1 [Time Frame: Up to 18 months], Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks [Time Frame: Up to 18 months], Duration of response (DOR) as determined by the Investigator according to RECIST v1.1 [Time Frame: Up to 18 months], Plasma concentration of domvanalimab [Time Frame: Up to 18 months], Plasma concentration of zimberelimab [Time Frame: Up to 18 months], Plasma concentration of quemliclustat [Time Frame: Up to 18 months], Percentage of participants with anti-drug antibodies to domvanalimab [Time Frame: Up to 18 months], Percentage of participants with anti-drug antibodies to zimberelimab [Time Frame: Up to 18 months]

Related papers

No related papers found yet.

Interventions

DRUGOXALIPLATIN

DRUGCALCIUM FOLINATE

DRUGQuemliclustat

DRUGZimberelimab

DRUGFLUOROURACIL

DRUGDOMVANALIMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and any Clinically meaningful trends in safety parameters [Time Frame: Up to 18 months], Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and assessed by the investigator [Time Frame: Up to 18 months]	—

Secondary

Measure	Time frame
Objective Response Rate (ORR) as measured by PD-L1 Expression Level [Time Frame: Up to 18 months], Overall survival (OS) [Time Frame: From date of first dose until the date of death due to any cause (approximately 18 months)], Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1 [Time Frame: Up to 18 months], Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks [Time Frame: Up to 18 months], Duration of response (DOR) as determined by the Investigator according to RECIST v1.1 [Time Frame: Up to 18 months], Plasma concentration of domvanalimab [Time Frame: Up to 18 months], Plasma concentration of zimberelimab [Time Frame: Up to 18 months], Plasma concentration of quemliclustat [Time Frame: Up to 18 months], Percentage of participants with anti-drug antibodies to domvanalimab [Time Frame: Up to 18 months], Percentage of participants with anti-drug antibodies to zimberelimab [Time Frame: Up to 18	—

Measure

Time frame

Objective Response Rate (ORR) as measured by PD-L1 Expression Level [Time Frame: Up to 18 months], Overall survival (OS) [Time Frame: From date of first dose until the date of death due to any cause (approximately 18 months)], Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1 [Time Frame: Up to 18 months], Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks [Time Frame: Up to 18 months], Duration of response (DOR) as determined by the Investigator according to RECIST v1.1 [Time Frame: Up to 18 months], Plasma concentration of domvanalimab [Time Frame: Up to 18 months], Plasma concentration of zimberelimab [Time Frame: Up to 18 months], Plasma concentration of quemliclustat [Time Frame: Up to 18 months], Percentage of participants with anti-drug antibodies to domvanalimab [Time Frame: Up to 18 months], Percentage of participants with anti-drug antibodies to zimberelimab [Time Frame: Up to 18

—

Countries

France

Outcome results

None listed