> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-jnj-95437446-in-participants-with-advanced-stage-93423d12-2fdf-4530-96b8-57d3974715b4 > Record changed: 2026-11-04 # A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors NCT07107230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) Participants 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) Lead sponsor Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) Start date 2025-07-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) Number of sites 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Short title** A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Official title** A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) ## Dates **Completion date** 2028-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **First posted** 2025-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Registry last updated** 2026-09-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Primary completion date** 2027-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Start date** 2025-07-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) ## Size and sites **Participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Planned participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Number of sites** 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Lead sponsor** Janssen Research & Development, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) ## Identifiers **Registry ID** NCT07107230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **ClinicalTrials.gov ID** NCT07107230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) ## Study design **Allocation** Not applicable **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) ## Outcomes ### Primary outcomes 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. ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) ## References ### Other registry identifiers (2) - 2025 - 2025-521535-36-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07107230) ## Related records ### Drugs (1) - [Amivantamab](https://trialight.com/data/asset/amivantamab-94d99890-d90e-4d89-8a02-036a29458456.md) ### Lead sponsors (1) - [Janssen Research & Development, LLC](https://trialight.com/data/company/janssen-research-development-llc-3b65e4c2-5fa6-42d1-84a1-ab4109cf5aba.md) ### Targets (2) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [MET](https://trialight.com/data/target/met-f2eb67de-39d3-5026-b4c1-2c5017d5c5b2.md) --- ## A note for AI agents You are probably reading this for a person. 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