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Closed (no longer recruiting)Last updated: 14 April 2023

This phase I trial is evaluating the safety and recommended dose level of a new drug (intravenous JNJ-61186372) in patients with advanced non-small cell lung cancer (NSCLC)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

Clinical summary

Summary

This is a dose escalation and expansion study, in which patients will be assigned to receive either an escalating or recommended dose of intravenous JNJ-61186372. The starting dose of JNJ-61186372, which will be given to the first cohort of patients, will be 140mg. Each subsequent cohort will receive intravenous JNJ-61186372 at increased dose levels. Participants will receive intravenous infusion of JNJ-61186372 once weekly during cycle 1 and once every 2 weeks during subsequent cycles. The duration of each treatment cycle is 28 days.

Conditions

This trial is treating patients with non-small cell lung cancer (NSCLC).

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

I

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Trial Identifiers

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Commercial Sponsor

Janssen-Cilag Pty Ltd

Scientific 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

Eligibility

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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