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

NCT07107230 · Janssen Research & Development, LLC
In plain English

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Official title
A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
About this study
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.
Eligibility criteria
Inclusion 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 Exclusion Criteria: * 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
Study design
Enrollment target: 380 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-15
Estimated completion: 2028-04-24
Last updated: 2026-04-13
Interventions
Drug: JNJ-95437446
Primary outcomes
  • Number of Participants with Adverse Events (AEs) by Severity (Up to 2 years and 4 months)
  • Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) (Up to 21 days)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
All locations (9)
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
Tennessee OncologyRecruiting
Nashville, Tennessee, United States
NEXT OncologyRecruiting
Fairfax, Virginia, United States
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Hosp Univ Vall D HebronRecruiting
Barcelona, Spain
Hosp Univ Fund Jimenez DiazRecruiting
Madrid, Spain
Hosp. Univ. 12 de OctubreRecruiting
Madrid, Spain
Hosp Univ Hm SanchinarroRecruiting
Madrid, Spain
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors · TrialPath