Advanced Stage Solid TumorsPhase 1NCT07107230
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
A Phase 1 study testing JNJ-95437446 and Amivantamab in people with Advanced Stage Solid Tumors, run by Janssen Research & Development, LLC at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Stage Solid Tumors
- What is being tested?
- JNJ-95437446 and Amivantamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 15 Jul 2025to 24 Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
NEXT Oncology
Fairfax, Virginia, 22031
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
- Recruiting
Columbia University Medical Center Herbert Irving Pavilion
New York, New York, 10032
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
Spain4 sites, 4 recruiting
- Recruiting
Hosp Univ Vall D Hebron
Barcelona, 8035
- Recruiting
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
- Recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
- Recruiting
Hosp Univ Hm Sanchinarro
Madrid, 28050
South Korea2 sites, 2 recruiting
- Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
- Recruiting
Samsung Medical Center
Seoul, 06351
About this study
Official title: A Phase 1 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.
- Conditions
- Advanced Stage Solid Tumors
- Being tested
- JNJ-95437446, Amivantamab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-95437446Drug
JNJ-95437446 will be administered.
AmivantamabDrug
Amivantamab will be administered.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-95437446 | Experimental | Participants will receive JNJ-95437446 in Part 1 until at least two recommended phase 2 doses (RP2Ds) has been developed. In selected participants in Part 1, amivantamab may also be co-dosed with JNJ-95437446. Participants in Part 2 will receive JNJ-95437446 at the RP2Ds developed in Part 1. Receives: Drug: JNJ-95437446; Drug: Amivantamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs) by Severity
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.
Measured: Up to 2 years and 4 months
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation.
Measured: Up to 21 days
Secondary outcomes (7)
Objective Response Rate
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).
Measured: Up to 2 years and 4 months
Duration of Response (DOR)
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.
Measured: Up to 2 years and 4 months
Progression Free Survival (PFS)
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.
Measured: Up to 2 years and 4 months
Maximum Plasma Concentration (Cmax) for JNJ-95437446
Serum samples will be analyzed to determine Cmax of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite.
Measured: Up to 2 years and 4 months
Time to Reach Cmax (Tmax) for JNJ-95437446
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.
Measured: Up to 2 years and 4 months
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
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.
Measured: Up to 2 years and 4 months
Number of Participants With Anti JNJ-95437446 Antibodies
Serum samples will be analyzed for the detection of anti-JNJ-95437446 antibodies using a validated assay method.
Measured: Up to 2 years and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start15 Jul 2025
- Primary completion18 Nov 2027 (estimated)
- Study completion24 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Stage Solid TumorsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107230
- Sponsor's protocol ID
- 95437446LUC1001
- Other IDs
- 2025-521535-36-00, 2025
- Status last verified
- Nov 2026
- First submitted
- 5 Aug 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
- ClinicalTrials.gov ID
- NCT07107230
- Acronym / sponsor ID
- 95437446LUC1001
- Conditions
- Advanced Stage Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 18 Nov 2027 (estimated)
- Study completion
- 24 Apr 2028 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JNJ-95437446 | Experimental | Drug: JNJ-95437446, Drug: AmivantamabParticipants will receive JNJ-95437446 in Part 1 until at least two recommended phase 2 doses (RP2Ds) has been developed. In selected participants in Part 1, amivantamab may also be co-dosed with JNJ-95437446. Participants in Part 2 will receive JNJ-95437446 at the RP2Ds developed in Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-95437446JNJ-95437446 will be administered. | Drug | JNJ-95437446 |
| AmivantamabAmivantamab will be administered. | Drug | JNJ-95437446 |
Primary outcome
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.
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.
7 secondary outcomes
Objective Response Rate
Time frame: Up to 2 years and 4 months
Duration of Response (DOR)
Time frame: Up to 2 years and 4 months
Progression Free Survival (PFS)
Time frame: Up to 2 years and 4 months
Maximum Plasma Concentration (Cmax) for JNJ-95437446
Time frame: Up to 2 years and 4 months
Time to Reach Cmax (Tmax) for JNJ-95437446
Time frame: Up to 2 years and 4 months
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
Number of Participants With Anti JNJ-95437446 Antibodies
Time frame: Up to 2 years and 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Related trials for Advanced Stage Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
GST101 in Participants With RAS-Mutant Advanced Solid Tumors
RAS-mutant Advanced Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-95437446 and Amivantamab in people with Advanced Stage Solid Tumors, run by Janssen Research & Development, LLC at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Spain, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) by Severity (time frame: Up to 2 years and 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.