Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)

Phase 3

Recruiting

• Conditions: Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)
• Interventions: Drug: ABP 234; Drug: Pembrolizumab

• Registration Number: NCT06430866
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-28
• Study Start: 2024-09-12
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-13
• Last Update Posted: 2025-08-14
• Primary Completion: 2026-03-27
• Study Completion: 2027-02-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

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).
• Medical conditions requiring systemic immunosuppression.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABP 234	ABP 234	Participants will receive ABP 234 every 3 weeks (Q3W) for up to 12 months.
Pembrolizumab	Pembrolizumab	Participants will receive pembrolizumab Q3W for up to 12 months.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Tmax at Steady State (Tmax_ss)	Weeks 16-19
Maximum Observed Serum Concentration (Cmax) Following the First Dose (Cmax_dose1)	Up to 65 weeks
Number of Participants with Andit-drug Antibodies	Baseline and weeks 4, 7, 16, 19, 22, 28, 40, 52, and 65
Disease-free Survival	Up to 65 weeks
Trough Serum Concentrations (Ctrough) at Pre-dose of Week 4 (Ctrough_w4)	Week 4 pre-dose
Ctrough at Stead State (Ctrough_ss)	Weeks 16 and 19 pre-dose
Time to Maximum Serum Concentration (Tmax) Following the First Dose (Tmax_dose1)	Up to 65 weeks
Cmax at Steady State (Cmax_ss)	Weeks 16-19
Number of Participants with Treatment-emergent Adverse Events	Up to 16 months
Number of Participants with Treatment-emergent Serious Adverse Events	Up to 16 months
Number of Participants with Treatment-emergent Adverse Events of Interest (EOIs)	Up to 16 months

Trial Locations

Locations (122)

Fundacion ARS Medica; 🇦🇷 San Salvador de Jujuy, Jujuy, Argentina

Ionc Instituto Oncologico De Cordoba; 🇦🇷 Cordoba, Argentina

University Multiprofile Hospital for Active Treatment Sofiamed; 🇧🇬 Sofia, Bulgaria

Centro de Investigaciones Clinicas Vina del Mar Ltda.; 🇨🇱 Viña Del Mar, Region De Valparaiso, Chile

Clinica Santa Maria; 🇨🇱 Santiago, Region Metropolitana, Chile

Cdiem; 🇨🇱 Providencia, Region Metropolotana, Chile

Instituto Oncologico Fundacion Arturo Lopez Perez (FALP); 🇨🇱 Providencia, Santiago, Chile

Centro de Oncologa de Precisin; 🇨🇱 Region Metropolitana, Santiago, Chile

Centro de Investigacin de Enfermedades Respiratorias e Inmunologicas Limitada CIERI; 🇨🇱 Vina del Mar, Valparaiso, Chile

K2 Oncology; 🇨🇱 Santiago de Chile, Chile

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