Ireland
--:--IST
Latest
Active, not recruiting Phase 3

Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)

NCT06430866 · tracked via the Priya Life Science Italy tracker
Sponsor
Phase
Phase 3
Started
2024-09-12
Last updated
2026-04-01

Condition(s) studied

Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

ABP 234 →Pembrolizumab →

ABP 234: Administered by intravenous (IV) injection.

Pembrolizumab: Administered by IV injection.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * Males and females ≥ 18 years of age. * Pathological diagnosis of non-squamous NSCLC. * Stage IB (T2 ≥ 4 cm), II, or IIIA NSCLC after complete surgical resection and received platinum-based chemotherapy. * For programmed death-ligand 1 (PD-L1) testing, tumor tissue from the resected site of disease must be sent, received, and analyzed for biomarkers. * Treated with platinum-based chemotherapy: 1. Chemotherapy must have begun within 12 weeks after the resection surgery. 2. The last chemotherapy dose must have been completed at least 3 weeks and no more than 12 weeks before the participant is randomized. * Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1. * Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS-1 negative. * Have adequate organ function as indicated by laboratory values. * Absence of severe comorbidities that in the opinion of the investigator might hamper participation in the study and/or treatment administration. * Participants must sign approved informed consent form (ICF). Exclusion Criteria: * Evidence of disease. * Prior treatment with anti-programmed cell death protein 1 and anti-PD-L1/2 modulating agents in adjuvant setting. * History or presence of immune-mediated disorders. * Participants with type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders not requiring systemic treatment are permitted to enroll. * Participant has positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C (HCV). * History of congenital immunodeficiency diseases, prior allogeneic stem cell transplantation, or organ transplantation. * History of any other malignancy other than NSCLC within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, etc. * Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis virus, current alcohol abuse or cirrhosis. * Surgery or chemotherapy-related toxicity not resolved to grade 1 with the exception of grade ≤ 2 alopecia, fatigue, neuropathy, and lack of appetite/nausea. * Woman of childbearing potential who is pregnant or is breast feeding. * Woman of childbearing potential who is not consenting to use highly effective methods of birth control. * Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control. * Participant has known hypersensitivity to monoclonal antibodies or to any of the excipients of the investigational product (IP). * Active cardiac disease or history of cardiac dysfunction, that in the judgment of the investigator would place the participant at additional risk when participating in the study. * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current neumonitis/interstitial lung disease. * Live vaccine therapy within 4 weeks prior to IP administration. * Participation in another investigational drug study within 30 days prior to IP administration.

Primary outcome measure(s)

  • Area Under the Serum Concentration-time Curve (AUC) From Time 0 to 21 Days (AUC21d) Following the First Dose — 21 days
  • AUC at Steady State Between Week 16 and Week 19 (AUCtau_ss) — Weeks 16-19

Trial sites (128)

FacilityCityRegionStatus
Fundacion ARS Medica San Salvador de Jujuy Jujuy Province
Instituto de Oncologia de Rosario Rosario Santa Fe Province
Ionc Instituto Oncologico De Cordoba Córdoba Argentina
University Multiprofile Hospital for Active Treatment Sofiamed Sofia Bulgaria
CDIEM - Centro de Investigacion y Especialidades Medicas Providencia Region Metropolotana
Instituto Oncologico Fundacion Arturo Lopez Perez (FALP) Providencia Santiago Metropolitan
Centro de Oncologia de Precision Region Metropolitana Santiago Metropolitan
Clinica Santa Maria Santiago Santiago Metropolitan
Centro de Investigaciones Clinicas Vina del Mar Ltda. Viña Del Mar Valparaiso
Centro de Investigacin de Enfermedades Respiratorias e Inmunologicas Limitada CIERI Viña del Mar Valparaiso
K2 Oncology Santiago Chile
Icegclinic Research and Care Santiago Chile
Clinique Belharra Ramsay Sante Bayonne France
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre Bordeaux France
Centre Francois Baclesse Caen France
Hopital Europeen Marseille Marseille France
Hopital Bichat, APHP Paris France
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hopital Sainte Musse Toulon France
Hopital Robert Schuman Vantoux France
LLC Todua Clinic Tbilisi Georgia
New Hospitals Tbilisi Georgia
Studienzentrum Aschaffenburg Aschaffenburg Germany
Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Internistische Onkologie und Hmatologie mit integire Essen Germany
Azienda Ospedaliero - Universitaria di Ferrara Cona Italy
Azienda Ospedaliera S. Croce e Carle Cuneo Italy
Azienda Ospedaliero-Universitaria Careggi Florence Italy
Ospedale Versilia Lucca Italy
Azienda USL 2 Lucca Lucca Italy
AOU Cagliari-Policlinico Universitario Duilio Casula di Monserrato-UOC Oncologia Medica Monserrato Italy
ASL Napoli 1 Centro-Ospedale del Mare Naples Italy
Casa Di Cura Polispecialistica Dott Pederzoli Peschiera del Garda Italy
AUSL Della Romagna - Ospedale S.Maria delle Croci Ravenna Italy
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa Rozzano Italy
Azienda Ospedaliera Santa Maria Terni Terni Italy
ASST Sette Laghi Varese Italy
Raja Perempuan Zainab II Hospital Kota Bharu Kelantan
Hospital Canselor Tuanku Muhriz UKM Cheras Kuala Lumpur
Hospital Umum Sarawak Kuching Sarawak
Preparaciones Oncolgicas S.C. León Guanajuato
Investigacion Biomedica para el Desarrollo de Nuevos Farmacos SA de CV Zapopan Jalisco

+ 88 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06430866 on ClinicalTrials.gov ↗ ← All trials in Italy