A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors

Neoplasms Clinical Trial

Official title:

A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04397276
• Other study ID #: CR108765
• Secondary ID: 2019-004885-1670
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 10, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.

Description:

JNJ-70218902, the investigational drug, has been shown in pre-clinical studies to work by attaching to cancer cells and activating immune cells to kill these cancer cells. This study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2) and will enroll adult men with Metastatic Castration-Resistant Prostate Cancer (MCRPC). Study evaluations will include preliminary clinical efficacy, safety, pharmacokinetics, biomarkers and immunogenicity evaluations. This study is divided into 3 periods: screening, treatment and post-treatment. The total duration of the study will be 2.5 years approximately.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed
• Measurable or evaluable disease
• Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy
• If the participant is receiving treatment with gonadotropin-releasing hormone agonists or antagonist analogs (GnRH), this therapy must have been initiated prior to first dose of study drug and must be continued throughout the study
• Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
• Adequate organs functions

Exclusion Criteria:

• Known brain metastases
• Concurrent use of any other anticancer treatment or investigational agent for the treatment of advanced disease
• Toxicities related to prior anticancer treatments have not returned to Grade less than or equal to (<=) 1 or baseline, except for alopecia and vitiligo
• Solid organ or bone marrow transplantation
• Known allergies, hypersensitivity, or intolerance to JNJ-70218902 or its excipients
• Certain comorbidities

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• JNJ-70218902
JNJ-70218902 will be administered.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	BC Cancer Agency - Vancouver BC	Vancouver	British Columbia
Israel	Rambam Medical Center	Haifa
Israel	Sourasky Medical Center	Tel Aviv
Spain	Hosp. Univ. Vall D Hebron	Barcelona
Spain	Hosp Univ Fund Jimenez Diaz	Madrid
Spain	Hosp. Univ. Hm Sanchinarro	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Canada,  Israel,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 2.5 years
Primary	Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)	Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.	Up to 21 days
Primary	Part 1 and Part 2: Number of Participants with AEs by Severity	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), which will be graded according to the 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 2.5 years
Secondary	Maximum Observed Serum Concentration (Cmax) of JNJ-70218902	Cmax is the maximum observed serum concentration of JNJ-70218902.	Up to 2.5 years
Secondary	Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-70218902	Tmax is defined as time to reach maximum observed serum concentration.	Up to 2.5 years
Secondary	Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-70218902	AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2.	Up to 2.5 years
Secondary	Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-70218902	AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval.	Up to 2.5 years
Secondary	Minimum Observed Serum Concentration (Cmin) of JNJ-70218902	Cmin is the minimum observed serum concentration of JNJ-70218902.	Up to 2.5 years
Secondary	Accumulation Ratio (RA) of JNJ-70218902	Accumulation Ratio (RA) is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC [0-24]) value at steady state divided by AUC (0-24) value after first dose.	Up to 2.5 years
Secondary	Systemic Cytokine Concentrations	Cytokines concentration will be measured for biomarker assessment.	Up to 2.5 years
Secondary	Serum Prostate Specific Antigen (PSA) Concentration	Serum prostate specific antigen (PSA) concentration will be measured.	Up to 2.5 years
Secondary	Number of Participants With Anti-JNJ-70218902 Antibodies	Number of participants with anti-JNJ-70218902 antibodies will be assessed.	Up to 2.5 years
Secondary	Objective Response Rate (ORR)	ORR is defined as the percentage of participants who have a Partial Response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3).	Up to 2.5 years
Secondary	Duration of Response (DOR)	Duration of response (DOR) will be calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first.	Up to 2.5 years