A Dose Escalation Study of JNJ-61186372 in Participants With Advanced Non-Small Cell Lung Cancer

Official Title

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects With Advanced Non-Small Cell Lung Cancer

Summary:

The purpose of this study is to evaluate the safety and pharmacokinetics, establish a recommended phase 2 dose (RP2D) regimens, and to assess the preliminary efficacy of JNJ-61186372 in participants with advanced non-small cell lung cancer (NSCLC).

Trial Description

Primary Outcome:

• Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
• Number of Participants With Adverse Events (AEs) and Serious AEs
• Percentage of Participants With Clinical Benefit
• Overall Response Rate (ORR)
• Duration of Response (DOR)

Secondary Outcome:

• Maximum Serum Concentration (Cmax) of JNJ-61186372
• Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-61186372
• Area Under the Serum Concentration-Time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-61186372
• Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-61186372
• Trough Serum Concentration (Ctrough) of JNJ-61186372
• Accumulation ratio (R) of JNJ-61186372
• Number of Participants With Anti-Drug Antibodies (ADA)
• Progression-Free Survival (PFS)
• Time to Treatment Failure (TTF)
• Overall Survival (OS)

This open label (all participants know the identity of the study drug), multicentre (more than one study site), first-in-human study consists of 2 parts. Part 1 is a dose escalation and Part 2 is a dose expansion cohort. In Part 1, participants with evaluable non-small cell lung cancer (NSCLC) will be enrolled into cohorts at increasing dose levels of JNJ-61186372, which will be administered in 28 day treatment cycles. The dose will be escalated until the maximum tolerated dose (MTD, or maximum administered dose [MAD], if no MTD is found) is reached. Part 1 will follow a traditional 3+3 design. At each dose level, 3 participants will complete Cycle 1. If no dose limiting toxicity (DLT) occurs in these 3 participants, then escalation will continue in a new cohort of 3 participants. Data from Part 1 will be used to determine one or more recommended phase 2 dose (RP2D) regimen(s). In Part 2, participants with documented epidermal growth factor receptor (EGFR) mutations and measurable disease, whose disease has progressed after previous treatment will be enrolled and receive JNJ-61186372 at the RP2D determined in Part 1. For both parts, the study consists of 3 periods: a Screening period (up to 28 days prior to the first dose of study drug); a Treatment period (first dose of study drug until 30 days after the last dose of study drug); and a Follow Up period (approximately 6 months). All participants will be followed for survival in the post-treatment follow-up period until the end of study and safety will be monitored throughout the study.

View this trial on ClinicalTrials.gov