A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 1

Conditions: Prostatic Neoplasms

Treatments: Drug: EPI-7386; Drug: Abiraterone Acetate; Drug: Prednisone or Prednisolone; Drug: Apalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05295927

2022-000946-14 (EudraCT Number)

CR109122

81712917PCR2001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumor activity of EPI-7386 in separate combinations with (a) AAP and (b) apalutamide (dose-expansion).

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed prostate adenocarcinoma
• Must be able to continue Gonadotropin-releasing hormone agonist (GnRHa) during the study if not surgically castrate
• Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1, or 2
• Must be able to swallow oral medicines
• Contraceptive use by men (and female partners of men enrolled in the study who are of childbearing potential or are pregnant) (birth control) use should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
• Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion criteria

• Known central nervous system (CNS) metastases
• Non-metastatic castration-resistant prostate cancer (CRPC) (biochemical or locoregional disease only) is excluded from trial participation
• Evidence of predominant neuroendocrine/small cell carcinoma features in archival or baseline tumor biopsy specimen(s)
• Symptomatic or impending spinal cord compression, except if participant has received definitive treatment and demonstrates evidence of clinically stable disease
• Known disorder affecting gastrointestinal absorption

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Group A: EPI-7386 + Abiraterone Acetate Plus Prednisone (AAP)

Experimental group

Description:

Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive EPI-7386 + AAP to determine the recommended phase 2 dose (RP2D) dose of EPI-7386 in combination with AAP in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with AAP.

Treatment:

Drug: Prednisone or Prednisolone

Drug: Abiraterone Acetate

Drug: EPI-7386

Group B: EPI-3786 + Apalutamide

Experimental group

Description:

Participants with mCRPC will receive EPI-7386 + apalutamide to determine RP2D dose of EPI-7386 in combination with apalutamide in dose finding portion of the study. In dose expansion portion of the study, participants will receive EPI-7386 RP2D in combination with apalutamide.

Treatment:

Drug: Apalutamide

Drug: EPI-7386