Recruiting

JNJ-95437446 for Advanced Solid Tumors

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What is being tested

JNJ-95437446

Drug
Who is being recruted

Colorectal Neoplasms

Over 18 Years
+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2025

See protocol details

Summary

Principal SponsorJanssen Research & Development, LLC
Study ContactStudy Contact
Last updated: October 10, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 15, 2025Actual date on which the first participant was enrolled.

This clinical trial is focused on evaluating a new medication, JNJ-95437446, for people with advanced-stage solid tumors. The main goal is to find the best dose of this new treatment by determining the recommended phase 2 doses. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas, and they can occur in various parts of the body. This study is important because it seeks to find a safer and more effective treatment option for patients whose cancer has progressed to an advanced stage, where current treatments might be less effective. In the study, participants will receive the medication JNJ-95437446, and researchers will monitor them to determine the most suitable dosage. This process helps ensure that future patients receive a dose that balances effectiveness with safety. The study is conducted in two parts: the first part determines the appropriate doses, and the second part evaluates the safety of these doses in more detail. While the study does not list specific risks or benefits, clinical trials typically involve careful monitoring to minimize risks and ensure participants' safety throughout the process.

Official TitleA Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors 
Principal SponsorJanssen Research & Development, LLC
Study ContactStudy Contact
Last updated: October 10, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
380 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colorectal Neoplasms
Criteria
6 inclusion criteria required to participate
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

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5 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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.
Study Objectives
Primary Objectives

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.

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 Objectives

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).

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.

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.

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

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.

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.

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Recruiting
Florida Cancer SpecialistsSarasota, United StatesSee the location
Recruiting
NEXT OncologyFairfax, United States
Recruiting
2 Study Centers