Recruitment Complete
Sponsor ID
20230127

Pharmacokinetic Similarity Between ABP 234 and Keytruda® (pembrolizumab)Eucalyptus

Sponsor ID
20230127
Clinicaltrials.gov ID
NCT06430866
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this study is to demonstrate pharmacokinetic (PK) similarity ABP 234 with pembrolizumab.

Additional Study Details

Phase
Phase 3
Product
ABP 234
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
163
Additional Study Details

Protocol Summary

Primary Outcome Measures

Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose

Timeframe: 21 days

AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss)

Timeframe: Weeks 16-19

Secondary Outcome Measures

Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1)

Timeframe: Up to 65 weeks

Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1)

Timeframe: Up to 65 weeks

Cmax at Steady State (Cmax_ss)

Timeframe: Weeks 16-19

Tmax at Steady State (Tmax_ss)

Timeframe: Weeks 16-19

Trough Serum Concentrations (Ctrough) at Pre-dose of Week 4 (Ctrough_w4)

Timeframe: Week 4 pre-dose

Ctrough at Stead State (Ctrough_ss)

Timeframe: Weeks 16 and 19 pre-dose

Number of Participants with Treatment-emergent Adverse Events

Timeframe: Up to 16 months

Number of Participants with Treatment-emergent Serious Adverse Events

Timeframe: Up to 16 months

Number of Participants with Treatment-emergent Adverse Events of Interest (EOIs)

Timeframe: Up to 16 months

Number of Participants with Andit-drug Antibodies

Timeframe: Baseline and weeks 4, 7, 16, 19, 22, 28, 40, 52, and 65

Disease-free Survival

Timeframe: Up to 65 weeks

Locations

Location
Status
Contact Us
Location
University Multiprofile Hospital for Active Treatment Sofiamed
Sofia, Bulgaria, 1797
Status
Recruiting
Location
Centro de Investigaciones Clinicas Vina del Mar Ltda.
Viña del Mar, Region de Valparaiso, Chile, 2540364
Status
Recruiting
Location
CDIEM - Centro de Investigacion y Especialidades Medicas
Providencia, Region Metropolotana, Chile, 7500859
Status
Recruiting
Location
Azienda Ospedaliera Santa Maria Terni
Terni, Italy, 05100
Status
Recruiting
Location
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemysl, Poland, 37-700
Status
Completed
Location
Clincial Centre of Serbia
Belgrade, Serbia, 11000
Status
Recruiting
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