A Study of JNJ-63898081 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03926013|
Recruitment Status : Active, not recruiting
First Posted : April 24, 2019
Last Update Posted : July 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: JNJ-63898081||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, First-in-Human, Dose Escalation Study of JNJ-63898081, in Subjects With Advanced Stage Solid Tumors|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||August 12, 2021|
|Estimated Study Completion Date :||November 7, 2022|
Experimental: Part 1: Dose Escalation
Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-63898081. Ascending dose levels will be sequentially tested.
JNJ-63898081 will be administered.
Experimental: Part 2: Dose Expansion
Participants with mCRPC or renal cell carcinoma (RCC) will receive JNJ-63898081 at the recommended Phase 2 dose (RP2D) determined in Part 1.
JNJ-63898081 will be administered.
- Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Approximately 3 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: Approximately 3 years ]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: Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) [ Time Frame: Approximately 3 years ]Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death.
- Part 1 and Part 2: Serum Concentrations of JNJ-63898081 [ Time Frame: Approximately 3 years ]Serum samples will be analyzed to determine concentrations of JNJ-63898081 using a validated method.
- Part 1 and 2: Systemic Cytokine Concentrations [ Time Frame: Approximately 3 years ]A panel of cytokines, including those proinflammatory ones, will be measured.
- Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies [ Time Frame: Approximately 3 years ]Anti-JNJ-63898081 antibodies will be evaluated in serum samples collected from all participants.
- Serum Prostate Specific Antigen (PSA) Concentration [ Time Frame: Approximately 3 years ]Serum prostate specific antigen (PSA) concentration will be assessed.
- Objective Response Rate (ORR) [ Time Frame: Approximately 3 years ]ORR is defined as the proportion of participants who have a PR or better according to the disease-specific response criteria. Evaluation of prostate treatment response will be performed according to Prostate Cancer Working Group 3 (PCWG3).
- Duration of Response [ Time Frame: Approximately 3 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 disease-specific response criteria, or death due to any cause, whichever occurs first. Evaluation of prostate treatment response will be performed according to Prostate Cancer Working Group 3 (PCWG3).
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): NCT03926013
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94158|
|United States, Maryland|
|NIH Clinical Center|
|Bethesda, Maryland, United States, 20892|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84112|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195-9472|
|Canada, British Columbia|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z4E6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|