A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04397276|
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : December 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: JNJ-70218902||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors|
|Actual Study Start Date :||July 10, 2020|
|Estimated Primary Completion Date :||November 28, 2022|
|Estimated Study Completion Date :||November 28, 2022|
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.
JNJ-70218902 will be administered.
Experimental: Part 2: Dose Expansion
Participants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1.
JNJ-70218902 will be administered.
- Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
- Maximum Observed Serum Concentration (Cmax) of JNJ-70218902 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 2.5 years ]Cmin is the minimum observed serum concentration of JNJ-70218902.
- Accumulation Ratio (RA) of JNJ-70218902 [ Time Frame: 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 [ Time Frame: Up to 2.5 years ]Cytokines concentration will be measured for biomarker assessment.
- Serum Prostate Specific Antigen (PSA) Concentration [ Time Frame: Up to 2.5 years ]Serum prostate specific antigen (PSA) concentration will be measured.
- Number of Participants With Anti-JNJ-70218902 Antibodies [ Time Frame: Up to 2.5 years ]Number of participants with anti-JNJ-70218902 antibodies will be assessed.
- Objective Response Rate (ORR) [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397276
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|United States, California|
|Cedars Sinai Medical Center||Not yet recruiting|
|Los Angeles, California, United States, 90048|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Canada, British Columbia|
|BC Cancer Agency - Vancouver BC||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Rambam Medical Center||Recruiting|
|Haifa, Israel, 31096|
|Sourasky Medical Center||Recruiting|
|Tel Aviv, Israel, 64239|
|Hosp. Univ. Vall D'Hebron||Recruiting|
|Barcelona, Spain, 08035|
|Hosp. Univ. Fund. Jimenez Diaz||Recruiting|
|Madrid, Spain, 28040|
|Hosp. Univ. Hm Sanchinarro||Recruiting|
|Madrid, Spain, 28050|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|