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

NCT07107230
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
400
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Lead sponsor
Janssen Research & Development, LLC
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Start date
2025-07-15
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Number of sites
10
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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.
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Short title
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
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Official title
A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-04-24
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First posted
2025-08-06
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Registry last updated
2026-09-29
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Primary completion date
2027-11-18
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Start date
2025-07-15
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Participants
400
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Participant count basis
Estimated
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Planned participants
400
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Protocol amendments
1
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Number of sites
10
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Janssen Research & Development, LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07107230
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ClinicalTrials.gov ID
NCT07107230
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Registry record
Open registry record
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Allocation
Not applicable
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of Participants with Adverse Events (AEs) by Severity

    Timeframe: 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)

    Timeframe: 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.

  1. Objective Response Rate

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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
Sources for eligibility
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  • Florida Cancer SpecialistsSarasota, United StatesRecruiting
  • Columbia University Medical Center Herbert Irving PavilionNew York, United StatesRecruiting
  • Tennessee OncologyNashville, United StatesRecruiting
  • NEXT OncologyFairfax, United StatesRecruiting
  • Severance Hospital Yonsei University Health SystemSeoul, South KoreaRecruiting
  • Samsung Medical CenterSeoul, South KoreaRecruiting
  • Hosp Univ Vall D HebronBarcelona, SpainRecruiting
  • Hosp Univ Fund Jimenez DiazMadrid, SpainRecruiting
  • Hosp. Univ. 12 de OctubreMadrid, SpainRecruiting
  • Hosp Univ Hm SanchinarroMadrid, SpainRecruiting
Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-521535-36-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (2)