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

NCT ID: NCT06255665

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-09
• Study Completion Date: 2025-06-23

Brief 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).

Conditions

Advanced Stage Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 (Dose Escalation): JNJ-79032421

In 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.

Group Type: EXPERIMENTAL

JNJ-79032421

Intervention Type: DRUG

JNJ-79032421 will be administered.

Part 2 (Dose Expansion): JNJ-79032421

In Part 2 (Dose expansion), participants will receive JNJ-79032421 at the RP2D regimen(s) determined in Part 1.

Group Type: EXPERIMENTAL

JNJ-79032421

Intervention Type: DRUG

JNJ-79032421 will be administered at RP2D regimen.

Interventions

JNJ-79032421

JNJ-79032421 will be administered.

Intervention Type: DRUG

JNJ-79032421

JNJ-79032421 will be administered at RP2D regimen.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Hosp Univ Vall D Hebron

Barcelona, , Spain

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Hosp Univ Hm Sanchinarro

Madrid, , Spain

Countries

Spain

Other Identifiers

79032421STM1001

Identifier Type: OTHER

Identifier Source: secondary_id

2023-504896-26-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR109341

Identifier Type: -

Identifier Source: org_study_id