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Advanced Stage Solid TumorsPhase 1NCT06255665

A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors

A Phase 1 study testing JNJ-79032421 in people with Advanced Stage Solid Tumors, run by Janssen Research & Development, LLC at 3 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-79032421 and to determine the safety and tolerability of JNJ-79032421 at the RP2D(s). 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-79032421
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
3 sitesSpain
Study dates
9 Feb 2024to 23 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Histologically or cytologically confirmed diagnosis of one of the following unresectable/locally advanced or metastatic solid tumors: a) Ovarian cancer includes high grade serous epithelial ovary, fallopian tube, or primary peritoneal cancer. Participants must have progressed after at least 2 prior lines of systemic therapy and have either, i) platinum-refractory disease (ie, persistent disease following completion of platinum-based primary chemotherapy); or ii) platinum-resistant recurrent disease; b) Primary pleural or peritoneal mesothelioma. Sarcomatoid and well differentiated papillary histologies are not allowed. Participants must have progressed after at least 1 prior line of systemic therapy; c) Pancreatic ductal adenocarcinoma. Other histologies and mixed histologies are not allowed. Participants must have progressed after at least 1 prior line of systemic therapy.
  • Measurable or evaluable disease: a) Part 1: Measurable or evaluable disease; b) Part 2: At least one measurable lesion per RECIST v1.1. Participants with mesothelioma must have disease measurable per mRECIST v1.1.
  • Can have a prior or concurrent second malignancy (other than the disease under study) whose natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1.
  • Selected participants in the pharmacokinetic and pharmacodynamic (PK/PD) cohorts (Part 1) as well as selected participants in Part 2 must agree to undergo mandatory tumor biopsies.

Who cannot join

  • History of known central nervous system (CNS) or leptomeningeal involvement.
  • Left ventricular ejection fraction on screening echocardiogram below normal institutional limits.
  • History of talc pleurodesis for pleural effusion within 3 months of starting study treatment.
  • Concurrent empyema of the lung pleural space requiring antibiotics or chest tube or evidence of resultant fistula formation.
  • History of hyperthermic intraperitoneal chemotherapy (HIPEC) within 6 months of starting study treatment.

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050

Other trials in Spain

About this study

Official title: A Phase 1 Study of JNJ-79032421, a T-cell Redirecting Agent Targeting Mesothelin for Advanced Stage Solid Tumors

The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-79032421 and to determine the safety and tolerability of JNJ-79032421 at the RP2D(s).

Being tested
JNJ-79032421

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-79032421Drug

    JNJ-79032421 will be administered.

  • JNJ-79032421Drug

    JNJ-79032421 will be administered at RP2D regimen.

Study groups in NCT06255665
Study groupRoleWhat they receive
Part 1 (Dose Escalation): JNJ-79032421ExperimentalIn Part 1 (Dose escalation), participants will receive JNJ-79032421. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.
Receives: Drug: JNJ-79032421
Part 2 (Dose Expansion): JNJ-79032421ExperimentalIn Part 2 (Dose expansion), participants will receive JNJ-79032421 at the RP2D regimen(s) determined in Part 1.
Receives: Drug: JNJ-79032421

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)

    The DLTs are adverse events including certain high grade non-hematologic or hematologic toxicities, or toxicities meeting other specific criteria.

    Measured: Up to first 21 days after first dose

  2. Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity

    An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events (ICANS), which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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 3 years

Secondary outcomes (8)

  1. Part 1 and Part 2: Serum Concentration of JNJ-79032421

    Serum concentration of JNJ-79032421 will be reported.

    Measured: Up to 3 years

  2. Part 1 and Part 2: Maximum Observed Analyte Concentration (Cmax) of JNJ-79032421

    Cmax is defined as maximum observed analyte concentration of JNJ-79032421.

    Measured: Up to 3 years

  3. Part 1 and Part 2: Time to Reach Maximum Observed Analyte Concentration (Tmax) of JNJ-79032421

    Tmax is defined as the time to reach maximum observed analyte concentration of JNJ-79032421.

    Measured: Up to 3 years

  4. Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-79032421

    AUC(t1-t2) is defined as area under the analyte concentration for a specific time interval defined by t1 and t2 (AUC[t1-t2]) of JNJ-79032421.

    Measured: Up to 3 years

  5. Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-79032421 Antibodies

    The maximum titers of antibodies to JNJ-79032421 will be summarized for participants positive with antibodies to JNJ-79032421.

    Measured: Up to 3 years

  6. Part 1 and Part 2: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with a best response of complete response or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1), and revised mRECIST for assessment of malignant pleural mesothelioma.

    Measured: Up to 3 years

  7. Part 1 and Part 2: Duration of Response (DOR)

    DOR is defined as the duration from the date of initial documentation of a response (PR or CR) to the date of first documented evidence of relapse or death according to RECIST v. 1.1, and revised mRECIST for malignant pleural mesothelioma.

    Measured: Up to 3 years

  8. Part 1 and Part 2: Cancer Antigen (CA) 125 Response Rate for Ovarian Cancer Only

    CA 125 response rate is defined as the proportion of participants with ovarian cancer who achieved a partial response or complete response according to the Gynecologic Cancer Intergroup (GCIG) response criteria for CA 125. A CA 125 response is defined as at least 50 percentage (%) reduction in CA 125 levels from a pretreatment sample which must be confirmed and maintained for at least 28 days.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2024
  2. Study start9 Feb 2024
  3. Primary completion23 Jun 2025
  4. Study completion23 Jun 2025

Resources

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
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06255665
Sponsor's protocol ID
CR109341
Other IDs
79032421STM1001, 2023-504896-26-00, 2023
Status last verified
Jul 2025
First submitted
5 Feb 2024
Last updated
20 Jul 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-79032421 in people with Advanced Stage Solid Tumors, run by Janssen Research & Development, LLC at 3 sites in Spain.

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 5 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: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) (time frame: Up to first 21 days after first dose). 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?

On the ClinicalTrials.gov record for NCT06255665.

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 20 Jul 2025.

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