Clinical trial NCT04397276: A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors
Official title: A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Neoplasms
Keywords: metastatic Castration-Resistant Prostate Cancer (mCRPC)
Prostate Cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-05-21
Enrollment: 82
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to 2.5 years
measure: Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
timeFrame: Up to 21 days
measure: Part 1 and Part 2: Number of Participants with AEs by Severity
timeFrame: Up to 2.5 years
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of JNJ-70218902
timeFrame: Up to 2.5 years
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-70218902
timeFrame: Up to 2.5 years
measure: Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-70218902
timeFrame: Up to 2.5 years
measure: Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-70218902
timeFrame: Up to 2.5 years
measure: Minimum Observed Serum Concentration (Cmin) of JNJ-70218902
timeFrame: Up to 2.5 years
measure: Accumulation Ratio (RA) of JNJ-70218902
timeFrame: Up to 2.5 years
measure: Systemic Cytokine Concentrations
timeFrame: Up to 2.5 years
measure: Serum Prostate Specific Antigen (PSA) Concentration
timeFrame: Up to 2.5 years
measure: Number of Participants With Anti-JNJ-70218902 Antibodies
timeFrame: Up to 2.5 years
measure: Objective Response Rate (ORR)
timeFrame: Up to 2.5 years
measure: Duration of Response (DOR)
timeFrame: Up to 2.5 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver BC
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
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: