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Recruiting Phase 1

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

NCT07107230 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1
Started
2025-07-15
Last updated
2026-09-29

Condition(s) studied

Advanced Stage Solid Tumors

Investigational drug(s) / intervention(s)

JNJ-95437446Amivantamab →

JNJ-95437446: JNJ-95437446 will be administered.

Amivantamab: Amivantamab will be administered.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of Participants with Adverse Events (AEs) by Severity — Up to 2 years and 4 months
    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
  • Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) — Up to 21 days
    The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation.

Trial sites (10)

FacilityCityRegionStatus
Florida Cancer Specialists Sarasota Florida Recruiting
Columbia University Medical Center Herbert Irving Pavilion New York New York Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
NEXT Oncology Fairfax Virginia Recruiting
Severance Hospital Yonsei University Health System Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Hosp Univ Vall D Hebron Barcelona Spain Recruiting
Hosp Univ Fund Jimenez Diaz Madrid Spain Recruiting
Hosp. Univ. 12 de Octubre Madrid Spain Recruiting
Hosp Univ Hm Sanchinarro Madrid Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07107230 on ClinicalTrials.gov ↗ ← All trials in Spain