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Clinical Trial 19389

Cancer Type: Thoracic
Interventions:JNJ-61186372

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Eric Haura

Call 813-745-6100
or 1-800-679-0775
Overview

Study 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 one or more 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).

Objective

Part 1 (Dose Escalation): -Determine the recommended Phase 2 dose(RP2D) regimen and the maximum tolerated dose (MTD), if one exists, for subjects with NSCLC treated with JNJ-61186372. Part 2 (Expansion): -Determine the safety, tolerability, and antitumor activity of JNJ-61186372 at the RP2D regimen in subjects with documented EGFR mutation(s) who have progressed after treatment with an EGFR inhibitor.

Inclusion Criteria

  • Participant must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is metastatic or unresectable. Participants must have either progressed after receiving prior therapy for metastatic disease, be ineligible for, or have refused all other currently available therapeutic options.
  • For Part 2 only: Patients must also have disease with a previously diagnosed activating EGFR mutation (includes both inhibitor sensitive primary mutations such as Exon 19 deletion and L858R, as well as marketed TKI-resistant mutations such as Exon 20 insertion). Documentation of EGFR mutation eligibility by CLIA-certified laboratory (or equivalent) testing is required.
  • For Part 2 only: Participants must also have an activating epidermal growth factor receptor (EGFR) mutation documented at the time of diagnosis (includes both inhibitor sensitive primary mutations such as exon 19 deletion and L858R, as well as inhibitor resistant mutations such as exon 20 insertion)
  • For Part 1: Participant must have evaluable disease. For Part 2: Participant must have measurable disease according to Response Criteria in Solid Tumors (RECIST) v1.1
  • For Part 2: Participants disease must have most recently progressed following treatment with a marketed EGFR inhibitor. Exception: In subjects diagnosed with mutations associated with de novo EGFR inhibitor resistance (e.g., exon 20 insertions), only previous treatment with combination platinum-based chemotherapy is required
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Participants must have adequate organ and bone marrow function.

  • Exclusion Criteria

  • Participant has uncontrolled inter-current illness, including but not limited to poorly controlled hypertension, other cardiovascular disease, or diabetes, ongoing or active infection, or psychiatric illness/social situation that would limit compliance with study requirements or confound study results.
  • Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives whichever is longer, before the first administration of JNJ-61186372. For agents with long half-lives, the maximum required time since last dose is 4 weeks. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less, (except for alopecia [any grade] and Grade less than or equal to [=> Participants with untreated brain metastases. Participants with treated metastases that clinically stable and asymptomatic for at least 2 weeks and who are off or receiving low-dose corticosteroid treatment (=> Participant has a history of malignancy other than the disease under study within 5 years before Screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with or minimal risk of recurrence within a year from screening).
  • Participant has a history of clinically significant cardiovascular disease.
  • Participant has leptomeningeal disease.
  • Participant has known allergies, hypersensitivities or intolerance to JNJ-61186372 or its excipients.
  • Participant has received an investigational drug including anti-cancer therapy or used an invasive investigational medical device within 6 weeks before the planned first dose of study drug or is currently enrolled in an investigational study.
  • Patients pregnant or breast-feeding or planning to become pregnant while enrolled in this study or within 6 months of the last dose of study drug.
  • Other exclusions apply.