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

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).

Study Overview

• Status: Recruiting
• Conditions: Advanced Stage Solid Tumors
• Intervention / Treatment: Drug: JNJ-79032421; Drug: JNJ-79032421

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hosp. Univ. Vall D Hebron
  • Madrid, Spain, 28040
    • Recruiting
    • Hosp. Univ. Fund. Jimenez Diaz
  • Madrid, Spain, 28050
    • Recruiting
    • Hosp. Univ. Hm Sanchinarro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: JNJ-79032421; JNJ-79032421 will be administered.; Drug: JNJ-79032421; JNJ-79032421 will be administered at RP2D regimen.
Experimental: 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.	Drug: JNJ-79032421; JNJ-79032421 will be administered.; Drug: JNJ-79032421; JNJ-79032421 will be administered at RP2D regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and Part 2: Serum Concentration of JNJ-79032421	Serum concentration of JNJ-79032421 will be reported.	Up to 3 years
Part 1 and Part 2: Maximum Observed Analyte Concentration (Cmax) of JNJ-79032421	Cmax is defined as maximum observed analyte concentration of JNJ-79032421.	Up to 3 years
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.	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	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.	Up to 3 years
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.	Up to 3 years
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.	Up to 3 years
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.	Up to 3 years
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.	Up to 3 years

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): February 10, 2027

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CR109341; 2023-504896-26-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes