A Phase I Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
Study Identifier:
87189401PCR1001
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.
To evaluate the safety, tolerability, and preliminary antitumor activity of JNJ-87189401 combined with JNJ-78278343 in mCRPC.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Prostate
Neuroendocrine
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Male
Age
18+ years
Study Drug
Drug: Experimental: Part 1 (Dose Escalation)
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
- Measurable or evaluable disease per PCWG3 criteria
- Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Must be 18 years of Age or older when signing the informed consent form
- The patient was histologically diagnosed with prostate adenocarcinoma. Adenocarcinomas with small cell or neuroendocrine (NE) features are permitted. However, small cell carcinoma, carcinoid carcinoma, mixed neuroendocrine carcinoma, or large cell neuroendocrine carcinoma are not permitted.
- According to the Prostate Cancer Working Group 3 (PCWG3) criteria outlined in the protocol, the disease is measurable or evaluable.
- A second primary tumor may exist previously or concurrently, and the natural course of that tumor or its treatment is unlikely to interfere with any safety or efficacy endpoints of the study.
- Parts 1, 2A, and 2B: Previous orchiectomy or medical castration; for subjects who have not undergone orchiectomy, they must be receiving androgen suppression therapy with a gonadotropin-releasing hormone (GnRH) analog (agonist or antagonist) prior to the first dose and continuing throughout the treatment period.
- The Eastern Cooperative Oncology Group (ECOG) performance status score was 0-1.
- Kidney function, liver function, and hematological parameters were within the range specified in the treatment plan.
- Human immunodeficiency virus (HIV) positive subjects can be enrolled if they meet the relevant criteria in the protocol.
- Participants must agree not to donate gametes (i.e., eggs or sperm) or have them cryopreserved for assisted reproductive purposes during the study period and for three months after the last dose. Because cancer treatment may impair fertility, gamete preservation is recommended before the study treatment.
- Participants must agree to use a condom during the study period and for three months after the last dose of medication, during any sexual activity that could result in ejaculation into another person.
- Participants must agree not to allow their partners to become pregnant during the study period and for 3 months after the last dose.
- Informed consent (ICF) must be signed, indicating that the participant understands the purpose and required procedures of the study and is willing to participate.
- Willing and able to comply with the lifestyle restrictions stipulated in this plan
Exclusion criteria
- History of an autoimmune disease within the 12 months prior to signing consent
- Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association [NYHA] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident
- History of solid organ or bone marrow/hematopoietic stem cell transplantation
- A venous thromboembolic event occurred within 1 month prior to the first dose; excluding uncomplicated deep vein thrombosis (≤ grade 2).
- Having an active autoimmune disease requiring systemic immunosuppressive therapy within 12 months prior to signing the informed consent form.
- An active infection requiring systemic antibiotic treatment within 7 days prior to the first dose is permitted. Prophylactic use of antibiotics or antiviral drugs is also permitted.
- A history of clinically significant cardiovascular disease
- Clinically significant lung function impairment, especially in patients requiring supplemental oxygen (greater than 2 L/min via nasal cannula) to maintain adequate oxygenation.
- It is known that there is an allergy, hypersensitivity, or intolerance to any component of JNJ-87189401 or JNJ-78278343.
- Subjects who have undergone major surgery or suffered significant trauma within 4 weeks prior to the first study dose, or who have not yet recovered from surgery; subjects must not plan to undergo major surgery during the study treatment period.
- Known malignant lesions of the central nervous system (CNS) or meninges
- Infectious active hepatitis: positive hepatitis B serology; hepatitis C infection; or other clinically active infectious liver diseases.
- Concomitant use of any anticancer therapy other than androgen deprivation therapy (ADT) or any other investigational drug within 2 weeks prior to the planned first dose is prohibited. Palliative radiotherapy for bone pain relief may be administered at any time before the first dose, but palliative radiotherapy for soft tissue lesions must be completed ≥ 2 weeks prior to the first dose.
- The patient has received systemic drug therapy at an immunosuppressive dose, such as Glucocorticoid(prednisone or equivalent at a dose >10 mg/day) within 3 days prior to the first dose.
- Subjects must not have previously received JNJ-78278343 treatment, unless the enrollment cohort specifically allows subjects who have previously received JNJ-78278343 treatment in a clinical trial.
- Patients who have received or are currently receiving any anti-CD28 antibody (αCD28), CD3-targeting therapy (excluding JNJ-78278343), anti-programmed cell death protein-1 antibody (αPD-1), anti-programmed death ligand-1 antibody (αPDL-1), anti-cytotoxic T-lymphocyte antigen-4 antibody (αCTLA-4), or other immunostimulatory anticancer drug therapy within 120 days prior to the first dose.
- Receive or plan to receive any live attenuated vaccine within 4 weeks before the first dose to 4 weeks after the last dose. Live attenuated influenza vaccine may be administered no later than 4 days before study treatment. Inactivated or non-replicating vaccines approved or authorized for emergency use by local regulatory authorities are permitted.
- Any serious underlying medical condition or other problem that may impair a trial participant's ability to receive or tolerate the planned treatment at the research center, to understand the informed consent form, or any condition that the investigator believes is not in the best interests of the trial participant (e.g., would impair their health), or any condition that may hinder, limit, or confuse the assessments required by the research protocol.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Drew Rasco
Status
Recruiting
Condition(s) Treated at Site
Prostate
Neuroendocrine
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Neel Belani
Bruno Fang
Status
Recruiting
Condition(s) Treated at Site
Prostate
Neuroendocrine