A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 1

Conditions: Neoplasms

Treatments: Drug: JNJ-70218902

Study type: Interventional

Funder types: Industry

Identifiers

NCT04397276

2024-516351-40-00 (Registry Identifier)

CR108765

70218902EDI1001 (Other Identifier)

2019-004885-16 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.

Full description

JNJ-70218902, the investigational drug, has been shown in pre-clinical studies to work by attaching to cancer cells and activating immune cells to kill these cancer cells. This study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2) and will enroll adult men with Metastatic Castration-Resistant Prostate Cancer (MCRPC). Study evaluations will include preliminary clinical efficacy, safety, pharmacokinetics, biomarkers and immunogenicity evaluations. This study is divided into 3 periods: screening, treatment and post-treatment. The total duration of the study will be 2.5 years approximately.

Enrollment: 82 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed
• Measurable or evaluable disease
• Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy
• If the participant is receiving treatment with gonadotropin-releasing hormone agonists or antagonist analogs (GnRH), this therapy must have been initiated prior to first dose of study drug and must be continued throughout the study
• Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
• Adequate organs functions

Exclusion criteria

• Known brain metastases
• Concurrent use of any other anticancer treatment or investigational agent for the treatment of advanced disease
• Toxicities related to prior anticancer treatments have not returned to Grade less than or equal to (<=) 1 or baseline, except for alopecia and vitiligo
• Solid organ or bone marrow transplantation
• Known allergies, hypersensitivity, or intolerance to JNJ-70218902 or its excipients
• Certain comorbidities

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Part 1: Dose Escalation

Experimental group

Description:

Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-70218902. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.

Treatment:

Drug: JNJ-70218902

Part 2: Dose Expansion

Experimental group

Description:

Participants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1.

Treatment:

Drug: JNJ-70218902