A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer
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: NCT04898634 |
Recruitment Status :
Recruiting
First Posted : May 24, 2021
Last Update Posted : April 24, 2024
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Condition or disease | Intervention/treatment | Phase |
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Prostatic Neoplasms | Drug: JNJ-78278343 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 165 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer |
Actual Study Start Date : | July 13, 2021 |
Estimated Primary Completion Date : | November 30, 2024 |
Estimated Study Completion Date : | November 15, 2025 |
Arm | Intervention/treatment |
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Experimental: JNJ-78278343
Participants will receive JNJ-78278343 either subcutaneously (SC injection or SC infusion) or intravenous (IV) infusion. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by the study evaluation team (SET) in Part 1 (dose escalation). In Part 2 (dose expansion), participants will receive JNJ-78278343 either SC or IV at recommended phase 2 dose (RP2D) as determined in Part 1.
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Drug: JNJ-78278343
JNJ-78278343 will be administered subcutaneously (injection or infusion) or via intravenous infusion. |
- Part 1 and 2: Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 1 year and 10 months ]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 and 2: Number of Participants With AEs by Severity [ Time Frame: Up to 1 year and 10 months ]Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. 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. Cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.
- Part 1: Number of Participants With Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 1 year and 10 months ]Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
- Serum Concentration of JNJ-78278343 [ Time Frame: Up to 1 year and 10 months ]Serum concentrations of JNJ-78278343 will be determined.
- Systemic Cytokine Concentrations [ Time Frame: Up to 1 year and 10 months ]Cytokine concentrations will be determined for biomarker assessment.
- Serum Prostate Specific Antigen (PSA) Concentration [ Time Frame: Up to 1 year and 10 months ]Serum PSA concentration will be measured.
- Number of Participants With Anti-JNJ-78278343 Antibodies [ Time Frame: Up to 1 year and 10 months ]Serum samples will be analyzed for the detection of anti-JNJ-78278343 antibodies using a validated assay method.
- Objective Response Rate (ORR) [ Time Frame: Up to 1 year and 10 months ]ORR is defined as the percentage of participants who have a partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version 1.1 response criteria without evidence of bone progression according to prostate cancer working group 3 (PCWG3).
- PSA Response Rate [ Time Frame: Up to 1 year and 10 months ]PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline. The maximum reduction from baseline in PSA will also be calculated during the treatment.
- Duration of Response (DOR) [ Time Frame: Up to 1 year and 10 months ]DOR will be calculated among responders (PR or better) 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed adenocarcinoma of the prostate which has spread to other body parts
- Part 1: Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy
- Measurable or evaluable disease
- Concurrent use of any other anticancer treatment must be discontinued for at least 2 weeks before the first dose of study drug
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Prior surgical removal of testicles; or, for participants who have not undergone surgical removal of testicles, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog
Exclusion Criteria:
Disease conditions
- Active central nervous system (CNS) involvement
- Toxicity related to prior anticancer therapy has not adequately recovered
Prior/Concomitant Therapy
- Prior treatment with human kallikrein (KLK) 2-targeted therapy
- Received, or are receiving, medications that suppress the immune system within 3 days prior to the first dose of study drug
- Received or plans to receive any live, attenuated vaccine within 4 weeks prior to the first dose of study drug
Prior/Concurrent Medical Conditions
- Diagnosis of cancer other than prostate cancer within 2 years prior to the first dose of study drug
- Solid organ or bone marrow transplantation
- Major clotting diseases within one month prior to the first dose of study drug
- Active autoimmune disease within 12 months prior to the first dose of study drug
- Active infection
- Major diseases of heart and blood vessels within 6 months prior to the first dose of study drug
- Clinically significant lung diseases
- Active or chronic hepatitis B or hepatitis C infection
- Known positive test result for human immunodeficiency virus (unless stable on antiretroviral therapy with undetectable viral load)
- Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment
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): NCT04898634
Contact: Study Contact | 844-434-4210 | Participate-In-This-Study@its.jnj.com |
United States, New York | |
Columbia University Medical Center Herbert Irving Pavilion | Recruiting |
New York, New York, United States, 10032 | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98195-9472 | |
France | |
Centre Leon Berard | Recruiting |
Lyon Cedex 8, France, 69373 | |
APHM Hopital Timone | Recruiting |
Marseille, France, 13005 | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, 94800 | |
Netherlands | |
NKI-AVL, Amsterdam | Recruiting |
Amsterdam, Netherlands, 1066 CX | |
Erasmus MC | Recruiting |
Rotterdam, Netherlands, 3015 GD | |
Spain | |
Hosp. Univ. Fund. Jimenez Diaz | Recruiting |
Madrid, Spain, 28040 | |
Hosp. Univ. Hm Sanchinarro | Recruiting |
Madrid, Spain, 28050 | |
Hosp. Virgen de La Victoria | Recruiting |
Málaga, Spain, 29010 |
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT04898634 |
Other Study ID Numbers: |
CR108958 2020-005970-83 ( EudraCT Number ) 78278343PCR1001 ( Other Identifier: Janssen Research & Development, LLC ) 2023-506585-31-00 ( Registry Identifier: EUCT number ) |
First Posted: | May 24, 2021 Key Record Dates |
Last Update Posted: | April 24, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu |
URL: | https://www.janssen.com/clinical-trials/transparency |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Metastatic castration-resistant prostate cancer (mCRPC) |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |