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Recruiting NCT07107230

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

Phase I Interventional Colorectal Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JNJ-95437446.
Who it may be relevant to
Registry conditions: Colorectal Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, South Korea, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Drug JNJ-95437446
    JNJ-95437446 will be administered.

Primary outcome measures

  • Number of Participants with Adverse Events (AEs) by Severity [Time frame: Up to 2 years and 4 months]
  • Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) [Time frame: Up to 21 days]
Secondary outcome measures (7)
  • Objective Response Rate [Time frame: Up to 2 years and 4 months]
  • Duration of Response (DOR) [Time frame: Up to 2 years and 4 months]
  • Progression Free Survival (PFS) [Time frame: Up to 2 years and 4 months]
  • Maximum Plasma Concentration (Cmax) for JNJ-95437446 [Time frame: Up to 2 years and 4 months]
  • Time to Reach Cmax (Tmax) for JNJ-95437446 [Time frame: Up to 2 years and 4 months]
  • Area Under the Plasma Concentration - Time (AUC [0-t]) Curve for JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite. [Time frame: Up to 2 years and 4 months]
  • Number of Participants With Anti JNJ-95437446 Antibodies [Time frame: Up to 2 years and 4 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Florida Cancer Specialists — Sarasota
  • Columbia University Medical Center Herbert Irving Pavilion — New York
  • Tennessee Oncology — Nashville
  • NEXT Oncology — Fairfax
Spain · 4 centers
  • Hosp Univ Vall D Hebron — Barcelona
  • Hosp Univ Fund Jimenez Diaz — Madrid
  • Hosp. Univ. 12 de Octubre — Madrid
  • Hosp Univ Hm Sanchinarro — Madrid
South Korea · 2 centers
  • Severance Hospital Yonsei University Health System — Seoul
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT07107230 · 95437446LUC1001 · 95437446LUC1001 · 2025-521535-36-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗