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NCT Number: NCT07107230

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-95437446

Drug

JNJ-95437446 will be administered.

Primary outcomes

  1. Number of Participants with Adverse Events (AEs) by Severity

    Time frame: 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.

  2. Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)

    Time frame: 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.

Secondary outcomes

  1. Objective Response Rate

    Time frame: Up to 2 years and 4 months

    Objective response rate (ORR) is defined as the percentage of participants who have best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST).

  2. Duration of Response (DOR)

    Time frame: Up to 2 years and 4 months

    DOR is defined for the responders from the date of initial documentation of a response to the date of first documented evidence of disease progression according to RECIST version (v.) 1.1, or death due to any cause, whichever occurs first.

  3. Progression Free Survival (PFS)

    Time frame: Up to 2 years and 4 months

    PFS is defined as the time from the first dose of JNJ-95437446 to either progressive disease (PD) or death due to any cause, whichever comes first.

  4. Maximum Plasma Concentration (Cmax) for JNJ-95437446

    Time frame: Up to 2 years and 4 months

    Serum samples will be analyzed to determine Cmax of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite.

  5. Time to Reach Cmax (Tmax) for JNJ-95437446

    Time frame: Up to 2 years and 4 months

    Tmax defined as the the time to reach maximum observed plasma concentration of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported.

  6. 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

    AUC (0-t) defined as area under the plasma concentration-time curve during a dosing interval of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported.

  7. Number of Participants With Anti JNJ-95437446 Antibodies

    Time frame: Up to 2 years and 4 months

    Serum samples will be analyzed for the detection of anti-JNJ-95437446 antibodies using a validated assay method.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 6, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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