Clinical trial NCT06255665: A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors
Official title: A Phase 1 Study of JNJ-79032421, a T-cell Redirecting Agent Targeting Mesothelin for Advanced Stage Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Stage Solid Tumors
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-02-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
timeFrame: Up to first 21 days after first dose
measure: Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
timeFrame: Up to 3 years
Secondary outcomes:
measure: Part 1 and Part 2: Serum Concentration of JNJ-79032421
timeFrame: Up to 3 years
measure: Part 1 and Part 2: Maximum Observed Analyte Concentration (Cmax) of JNJ-79032421
timeFrame: Up to 3 years
measure: Part 1 and Part 2: Time to Reach Maximum Observed Analyte Concentration (Tmax) of JNJ-79032421
timeFrame: Up to 3 years
measure: Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-79032421
timeFrame: Up to 3 years
measure: Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-79032421 Antibodies
timeFrame: Up to 3 years
measure: Part 1 and Part 2: Objective Response Rate (ORR)
timeFrame: Up to 3 years
measure: Part 1 and Part 2: Duration of Response (DOR)
timeFrame: Up to 3 years
measure: Part 1 and Part 2: Cancer Antigen (CA) 125 Response Rate for Ovarian Cancer Only
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Madrid
country: Spain
facility: Hosp Univ Fund Jimenez Diaz
city: Madrid
country: Spain
facility: Hosp Univ Hm Sanchinarro
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: