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

NCT06255665 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR10934179032421STM10012023-504896-26-00
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to first 21 days after first dose

• 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.

  Up to 3 years

Secondary Outcomes (8)

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

  Up to 3 years

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

  Up to 3 years

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

  Up to 3 years

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

  Up to 3 years

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

  Up to 3 years

Study Arms (2)

Part 1 (Dose Escalation): JNJ-79032421

EXPERIMENTAL

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.

Drug: JNJ-79032421

Part 2 (Dose Expansion): JNJ-79032421

EXPERIMENTAL

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

Drug: JNJ-79032421

Interventions

JNJ-79032421 DRUG

JNJ-79032421 will be administered.

Part 1 (Dose Escalation): JNJ-79032421

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (3)

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

Location

Hosp Univ Hm Sanchinarro

Madrid, 28050, Spain

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: February 9, 2024
• Primary Completion: June 23, 2025
• Study Completion: June 23, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (3)