A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1: Dose Escalation Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-70218902. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. |
Drug: JNJ-70218902
JNJ-70218902 will be administered.
|
| Experimental: Part 2: Dose Expansion Participants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1. |
Drug: JNJ-70218902
JNJ-70218902 will be administered.
|
Outcome Measures
Primary Outcome Measures
- Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [Up to 2.5 years]
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.
- Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) [Up to 21 days]
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.
- Part 1 and Part 2: Number of Participants with AEs by Severity [Up to 2.5 years]
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.
Secondary Outcome Measures
- Maximum Observed Serum Concentration (Cmax) of JNJ-70218902 [Up to 2.5 years]
Cmax is the maximum observed serum concentration of JNJ-70218902.
- Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-70218902 [Up to 2.5 years]
Tmax is defined as time to reach maximum observed serum concentration.
- Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-70218902 [Up to 2.5 years]
AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2.
- Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-70218902 [Up to 2.5 years]
AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval.
- Minimum Observed Serum Concentration (Cmin) of JNJ-70218902 [Up to 2.5 years]
Cmin is the minimum observed serum concentration of JNJ-70218902.
- Accumulation Ratio (RA) of JNJ-70218902 [Up to 2.5 years]
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.
- Systemic Cytokine Concentrations [Up to 2.5 years]
Cytokines concentration will be measured for biomarker assessment.
- Serum Prostate Specific Antigen (PSA) Concentration [Up to 2.5 years]
Serum prostate specific antigen (PSA) concentration will be measured.
- Number of Participants With Anti-JNJ-70218902 Antibodies [Up to 2.5 years]
Number of participants with anti-JNJ-70218902 antibodies will be assessed.
- Objective Response Rate (ORR) [Up to 2.5 years]
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).
- Duration of Response (DOR) [Up to 2.5 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed
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Measurable or evaluable disease
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Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy
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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
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Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
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Adequate organs functions
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Archived tissue at baseline are requested
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Participants with accessible lesions enrolled in selected cohorts in Part 1 and 2 will undergo fresh tumor biopsies
Exclusion Criteria:
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Known brain metastases
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Concurrent use of any other anticancer treatment or investigational agent for the treatment of advanced disease
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Toxicities related to prior anticancer treatments have not returned to Grade less than or equal to (<=) 1 or baseline, except for alopecia and vitiligo
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Solid organ or bone marrow transplantation
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Known allergies, hypersensitivity, or intolerance to JNJ-70218902 or its excipients
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Certain comorbidities
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 2 | Massachusetts General | Boston | Massachusetts | United States | 02114 |
| 3 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 4 | University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 5 | BC Cancer Agency - Vancouver BC | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 6 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 7 | Rambam Medical Center | Haifa | Israel | 31096 | |
| 8 | Sourasky Medical Center | Tel Aviv | Israel | 64239 | |
| 9 | Hosp. Univ. Vall D Hebron | Barcelona | Spain | 08035 | |
| 10 | Hosp. Univ. Fund. Jimenez Diaz | Madrid | Spain | 28040 | |
| 11 | Hosp. Univ. Hm Sanchinarro | Madrid | Spain | 28050 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108765
- 2019-004885-16
- 70218902EDI1001