Gender
Male
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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 (example, 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 and 4b: Metastatic HSPC with non-castrate
levels of testosterone (>150 mg/mL). Must be ineligible for or unwilling to take ADT
or other AR-targeted therapy at this time. In addition: For Part 4b: 1) must have
recurrent disease after definitive treatment to the prostate that is metastatic
either to bone, lymph node, or both without evidence of either measurable or
non-measurable metastasis to visceral organs. 2) must have oligometastatic disease
that can be encompassed in ≤5 radiation fields
- 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 (for example [eg], soft tissue lesions) must be completed >
2 weeks prior to start of study drug except for palliative radiotherapy for pain
(eg, 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