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

NCT ID: NCT07107230

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2027-11-28

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JNJ-95437446

Participants will receive JNJ-95437446 in Part 1 until at least two recommended phase 2 doses (RP2Ds) has been developed. Participants in Part 2 will receive JNJ-95437446 at the RP2Ds developed in Part 1.

Group Type EXPERIMENTAL

JNJ-95437446

Intervention Type DRUG

JNJ-95437446 will be administered.

Interventions

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JNJ-95437446

JNJ-95437446 will be administered.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Florida Cancer Specialists

Sarasota, Florida, United States

Site Status RECRUITING

NEXT Oncology

Fairfax, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: [email protected]

Other Identifiers

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95437446LUC1001

Identifier Type: OTHER

Identifier Source: secondary_id

2025-521535-36-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

95437446LUC1001

Identifier Type: -

Identifier Source: org_study_id