A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer

Janssen (J&J Innovative Medicine)

Status and phase

Enrolling

Phase 1

Conditions

Metastatic Castration-resistant Prostate Neoplasms

Treatments

Drug: Cabazitaxel

Drug: Enzalutamide

Drug: Apalutamide

Drug: Cetrelimab

Drug: Abiraterone acetate plus prednisone (AAP)

Drug: Docetaxel

Drug: JNJ-78278343

Drug: Darolutamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05818683

78278343PCR1003 (Other Identifier)

CR109321

2022-503132-14-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).

Enrollment

185 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Part 1 A-G (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone [AAP]): mCRPC: Histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 nanogram [ng]/milliliter (mL); Part 2H (apalutamide): (a) metastatic hormone-sensitive prostate cancer(mHSPC) with non-castrate levels of testosterone (greater than [>] 150 ng/ deciliter [dL]) and a minimum PSA of 2 ng/milliliter [mL]; (b) Metastatic disease documented by greater than equal to (>=) 1 bone lesion(s) on technetium-99m (99m^Tc) bone scan. No definitive evidence of metastatic visceral disease
Measurable or evaluable disease
(a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) Part 1C and 2C (docetaxel), Part 1D (apalutamide), Part 1E and 2E (enzalutamide), Part 1F and 2F (darolutamide), and Part 1G and 2G (AAP)- Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel. (d) Part 2D (apalutamide) - Prior treatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant must not have received prior cytotoxic chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ functions

Exclusion criteria

Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications
Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels (except for alopecia, vitiligo, Grade <=2 peripheral neuropathy)
Solid organ or bone marrow transplantation
Known allergies, or intolerance to any of the components (example, excipients) of JNJ-78278343, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1C and 2C , apalutamide (Part 1D and 2D and Part 2H), enzalutamide (Part 1E and 2E), darolutamide (Part 1F and 2F), or AAP (Part 1G and 2G)
Significant infections or serious lung, heart or other medical conditions

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

185 participants in 1 patient group

JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)

Experimental group

Description:

Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion).

Treatment: