En studie av JNJ-69086420, et Actinium-225-merket antistoff rettet mot human Kallikrein-2 (hK2) for avansert prostatakreft
En fase 1-studie av JNJ-69086420, et Actinium-225-merket antistoff rettet mot Human Kallikrein-2 (hK2) for avansert prostatakreft
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of JNJ-69086420 in Part 1 (Dose Escalation), to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion), to determine safety of JNJ-69086420 at the RP2D(s) as a combination therapy in Part 3 (combination therapy) and to determine safety of JNJ-69086420 at the RP2D(s) in participants with metastatic hormone-sensitive prostate cancer (mHSPC) in Part 4.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85054
- Mayo Clinic Arizona
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California
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Duarte, California, Forente stater, 91010
- City of Hope
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Florida
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Jacksonville, Florida, Forente stater, 32224
- Mayo Clinic in Florida
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Illinois
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Chicago, Illinois, Forente stater, 60637
- University of Chicago
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Louisiana
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Metairie, Louisiana, Forente stater, 70006
- East Jefferson General Hospital
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New Orleans, Louisiana, Forente stater, 70112
- Tulane University Hospital & Clinics
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Rochester
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Nebraska
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Omaha, Nebraska, Forente stater, 68130
- XCancer Omaha / Urology Cancer Center
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New York
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New York, New York, Forente stater, 10065
- Memorial Sloan Kettering Cancer Center
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Case Western Reserve University
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Utah
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Salt Lake City, Utah, Forente stater, 84112
- University of Utah Huntsman Cancer Institute
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- For Part 1, Part 2, Part 3: Metastatic castration resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma (adenocarcinoma with small-cell or neuroendocrine features is allowed) with prior exposure to at least one androgen receptor (AR) targeted therapy (for example [e.g.], abiraterone acetate, enzalutamide, apalutamide, darolutamide). In addition: Part 1: prior taxane or other chemotherapy is acceptable but not required. Part 2a: prior taxane or other chemotherapy required, Part 2b: no prior taxane or other chemotherapy, Part 2c: mCRPC that has progressed after prior treatment with lutetium Lu-177 vipivotide tetraxetan, with or without prior chemotherapy, Part 3: prior taxane or other chemotherapy is acceptable but not required & For Part 4a: metastatic HSPC, For Part 4b: disease that can be treated with less than or equal to (<=) 5 radiation fields and no visceral metastases
- Parts 1, 2 & 3: Prior orchiectomy or medical castration, or, for 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. This criterion does not apply to Part 4
- Palliative radiotherapy (e.g. soft tissue lesions) must be completed greater than (>) 2 weeks prior to start of study drug except for palliative radiotherapy for pain (e.g., bone pain), which may be used any time prior to first dose
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ functions as reflected in laboratory parameters
Exclusion Criteria:
- Prior treatment with radium Xofigo (Ra 223 dichloride), strontium, samarium, or other radioconjugate therapy, other systemic anti-neoplastic therapy <=30 days prior to the first dose of study drug except for luteinizing hormone-releasing hormone agonists/antagonists or GnRH agonists/antagonists. Novel androgen axis drugs <=14 days prior to the first dose of study drug. In addition: Part 2b: Must not have received prior treatment with chemotherapy (eg, docetaxel) or poly ADP ribose polymerase (PARP) inhibitors, Part 2c: Prior treatment with lutetium Lu-177 vipivotide tetraxetan is required, but must have been completed >42 days prior to first dose of study drug, Part 3: Must not have received prior treatment with JNJ-78278343, Part 4: Must not have received ADT or AR-targeted therapy less than or equal to (<=) 56 days prior to first dose of study drug
- Known history of myelodysplastic syndrome, leukemia, or hematological malignancy with features suggestive of myelodysplastic syndrome/acute myeloid leukemia at any timepoint
- Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade <= 1 (except alopecia, radiation tissue fibrosis, or peripheral neuropathy)
- Known allergies, hypersensitivity, or intolerance to JNJ-69086420 or its excipients and protein therapeutics. For Part 3, known allergies, hypersensitivity, or intolerance to JNJ-78278343 or its excipients or protein therapeutics
- Active or chronic hepatitis B or hepatitis C infection
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Part 1: Dose Escalation
Participants will receive JNJ-69086420 with one or multiple doses. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. |
Participants will receive JNJ-69086420.
Andre navn:
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Eksperimentell: Part 2: Dose Expansion
Participants in one or more cohorts will receive JNJ-69086420 at the RP2D(s) determined in Part 1. |
Participants will receive JNJ-69086420.
Andre navn:
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Eksperimentell: Part 3: Combination Therapy
Participants will receive JNJ-69086420 at the determined RP2D(s) and fixed dose of JNJ-78278343. |
Participants will receive JNJ-69086420.
Andre navn:
Participants will receive JNJ-78278343. |
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Eksperimentell: Part 4: HSPC Expansion
Participants with HSPC will receive JNJ-69086420 at the RP2D(s) in Part 4(a), and JNJ-69086420 following stereotactic body radiation therapy in Part 4(b). |
Participants will receive JNJ-69086420.
Andre navn:
Participants will receive stereotactic body radiaition therapy. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Tidsramme: Up to 2 years and 4 months
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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. |
Up to 2 years and 4 months
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Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
Tidsramme: Up to 2 years and 4 months
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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. |
Up to 2 years and 4 months
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Number of Participants with AEs by Severity
Tidsramme: Up to 2 years and 4 months
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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. |
Up to 2 years and 4 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants with Prostate Specific Antigen (PSA) Response
Tidsramme: Up to 2 years and 4 months
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PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline and that is subsequently confirmed. |
Up to 2 years and 4 months
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Overall Response Rate (ORR)
Tidsramme: Up to 2 years and 4 months
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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). |
Up to 2 years and 4 months
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Maximum Observed Serum Concentration/Radioactivity (Cmax) of JNJ-69086420
Tidsramme: Up to 2 years and 4 months
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Cmax is defined as the maximum observed serum concentration/radioactivity of JNJ-69086420. |
Up to 2 years and 4 months
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Time to Reach Maximum Observed Serum Concentration/Radioactivity (Tmax) of JNJ-69086420
Tidsramme: Up to 2 years and 4 months
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Tmax is defined as time to reach maximum observed serum concentration/radioactivity of JNJ-69086420. |
Up to 2 years and 4 months
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Area Under the Serum Concentration-time Curve From Time Zero to t Time (AUC[0-t]) of JNJ-69086420
Tidsramme: Up to 2 years and 4 months
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AUC(0-t) is defined as the area under the serum concentration-time curve from time zero to t of JNJ-69086420. |
Up to 2 years and 4 months
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Number of Participants With Anti-JNJ-69086420 Antibodies
Tidsramme: Up to 2 years and 4 months
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Number of participants with anti-JNJ-69086420 antibodies will be assessed to evaluate the potential immunogenicity. |
Up to 2 years and 4 months
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Part 3: Serum Concentration of JNJ-78278343
Tidsramme: Up to 2 years and 4 months
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Venous blood samples will be collected for assessment of serum concentrations of JNJ-78278343. |
Up to 2 years and 4 months
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Part 3:Number of Participants With Anti-JNJ-78278343 Antibodies
Tidsramme: Up to 2 years and 4 months
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Number of participants with anti-JNJ-78278343 antibodies will be assessed to evaluate the potential immunogenicity. |
Up to 2 years and 4 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Genitale neoplasmer, hanner
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kjønnssykdommer, mannlige
- Prostata sykdommer
- Mannlige urogenitale sykdommer
- Neoplasmer etter histologisk type
- Neoplasmer, kjertel og epitel
- Karsinom
- Prostatiske neoplasmer
- Adenokarsinom
- Undersøkelsesteknikker
- Terapeutikk
- Kirurgiske prosedyrer, operativ
- Strålebehandling
- Stereotaksiske teknikker
- Nevrokirurgiske prosedyrer
- Radiokirurgi
Andre studie-ID-numre
- CR108817
- 69086420PCR1001 (Annen identifikator: Janssen Research & Development, LLC)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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
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