RECRUITING

A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors

Description

The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.

Study Overview

Study Details

Study overview

The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.

A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors

A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors

Condition
Colorectal Neoplasms
Intervention / Treatment

-

Contacts and Locations

Sarasota

Florida Cancer Specialists, Sarasota, Florida, United States, 34232

Fairfax

NEXT Oncology, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants must have been previously diagnosed with histologically confirmed unresectable, locally advanced, or metastatic non-small cell lung cancer, colorectal carcinoma, or head and neck squamous cell carcinoma
  • * Participants with non-small cell lung cancer (NSCLC) adenocarcinoma and colorectal cancer (CRC) must have local molecular testing to determine epidermal growth factor receptor (EGFR) mutational status for NSCLC and Kirsten rat sarcoma/neuroblastoma ras viral oncogene/v-raf murine sarcoma oncogene B1 (KRAS/NRAS/BRAF) mutation status for CRC
  • * Have measurable or evaluable disease:
  • * Part 1: Either measurable or evaluable disease; Part 2: At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version (v) 1.1
  • * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 at screening
  • * Participants must have appropriate hematologic, renal, and hepatic function within the required limits
  • * Any prior medical history of ILD/pneumonitis, including pneumonitis from anti-PD-1/ PD-L1 antibody or radiation that required systemic steroids
  • * Toxicity from prior anticancer therapy that has not resolved to Grade \<=1
  • * Evidence of clinically significant active viral, bacterial, or fungal infection within 7 days before the first dose of study treatment requiring systemic or non-topical treatment
  • * History of clinically significant cardiovascular disease within 6 months prior to signing informed consent
  • * Participants with prior or concurrent second malignancy cannot be enrolled if prior/concurrent malignancy's natural history of treatment is likely to interfere with any safety or efficacy study endpoints

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Study Record Dates

2027-11-28