A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate Denikitug as Monotherapy or in Combination With Nivolumab or Chemotherapy in Participants With HER2-Negative, Unresectable, Recurrent, and/or Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas

Conditions

and esophageal adenocarcinomas, and/or metastatic gastric, GEJ, HER2-negative, recurrent, unresectable

Brief summary

ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST Version 1.1.

Detailed description

DOR is measured from the time of first response (CR or PR) as assessed by investigator, per RECIST Version 1.1 until the date of first documented progressive disease (PD) or death, whichever comes first., PFS is the time from date of first dose until PD or death from any cause, whichever comes first as assessed by the investigator according to RECIST Version 1.1., OS is length of time from first dose until the date of death from any cause., The incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs) and incidence and severity of clinical laboratory abnormalities graded according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0., Serum concentration of DEN and estimated PK parameters (eg, Cmax, AUCall)., Percentage of treatment-emergent antidrug (DEN) antibody (ADA)-positive and ADA-negative participants.

Related papers

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Interventions

DRUGGS-1811 150 mg/vial concentrate for solution for infusion

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGCyramza 10 mg/ml concentrate for solution for infusion

DRUGGS-1811

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST Version 1.1.	—

Secondary

Measure	Time frame
DOR is measured from the time of first response (CR or PR) as assessed by investigator, per RECIST Version 1.1 until the date of first documented progressive disease (PD) or death, whichever comes first., PFS is the time from date of first dose until PD or death from any cause, whichever comes first as assessed by the investigator according to RECIST Version 1.1., OS is length of time from first dose until the date of death from any cause., The incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs) and incidence and severity of clinical laboratory abnormalities graded according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0., Serum concentration of DEN and estimated PK parameters (eg, Cmax, AUCall)., Percentage of treatment-emergent antidrug (DEN) antibody (ADA)-positive and ADA-negative participants.	—

Measure

Time frame

DOR is measured from the time of first response (CR or PR) as assessed by investigator, per RECIST Version 1.1 until the date of first documented progressive disease (PD) or death, whichever comes first., PFS is the time from date of first dose until PD or death from any cause, whichever comes first as assessed by the investigator according to RECIST Version 1.1., OS is length of time from first dose until the date of death from any cause., The incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs) and incidence and severity of clinical laboratory abnormalities graded according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0., Serum concentration of DEN and estimated PK parameters (eg, Cmax, AUCall)., Percentage of treatment-emergent antidrug (DEN) antibody (ADA)-positive and ADA-negative participants.

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Outcome results

None listed