A Study of JNJ-79032421 Targeting Mesothelin for Advanced Stage Solid Tumors
- Registration Number
- NCT06255665
- Lead Sponsor
- Janssen Research & Development, LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1 (Dose Escalation): JNJ-79032421 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. Part 2 (Dose Expansion): JNJ-79032421 JNJ-79032421 In Part 2 (Dose expansion), participants will receive JNJ-79032421 at the RP2D regimen(s) determined in Part 1.
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) Up to first 21 days after first dose The DLTs are adverse events including certain high grade non-hematologic or hematologic toxicities, or toxicities meeting other specific criteria.
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity Up to 3 years 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.
- Secondary Outcome Measures
Name Time Method Part 1 and Part 2: Serum Concentration of JNJ-79032421 Up to 3 years Serum concentration of JNJ-79032421 will be reported.
Part 1 and Part 2: Maximum Observed Analyte Concentration (Cmax) of JNJ-79032421 Up to 3 years Cmax is defined as maximum observed analyte concentration of JNJ-79032421.
Part 1 and Part 2: Time to Reach Maximum Observed Analyte Concentration (Tmax) of JNJ-79032421 Up to 3 years Tmax is defined as the time to reach maximum observed analyte concentration of JNJ-79032421.
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 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.
Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-79032421 Antibodies Up to 3 years The maximum titers of antibodies to JNJ-79032421 will be summarized for participants positive with antibodies to JNJ-79032421.
Part 1 and Part 2: Objective Response Rate (ORR) Up to 3 years 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.
Part 1 and Part 2: Duration of Response (DOR) Up to 3 years 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.
Part 1 and Part 2: Cancer Antigen (CA) 125 Response Rate for Ovarian Cancer Only Up to 3 years 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.
Trial Locations
- Locations (3)
Hosp Univ Vall D Hebron
🇪🇸Barcelona, Spain
Hosp Univ Fund Jimenez Diaz
🇪🇸Madrid, Spain
Hosp Univ Hm Sanchinarro
🇪🇸Madrid, Spain