A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: JNJ-63898081

Study type: Interventional

Funder types: Industry

Identifiers

NCT03926013

CR108593

63898081EDI1001 (Other Identifier)

Details and patient eligibility

About

The main purpose of this study are to determine the recommended Phase 2 dose (RP2D) regimen and the maximum tolerated dose, and to determine the safety of JNJ-63898081.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histology: Part 1: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed. mCRPC is defined by prostate Cancer Working Group (PCWG )3 criteria. Part 2: mCRPC as defined above or pathologically confirmed metastatic renal cell carcinoma (RCC) as defined by world health organization (WHO) 2016 Classifications
• Measurable or evaluable disease: Part 1: Either measurable or evaluable disease for prostate cancer. Part 2: At least one measurable lesion as per RECIST v1.1.
• Evidence of disease progression on prior therapy that requires a new line of treatment
• Participants with accessible lesions enrolled in selected pharmacokinetic (PK)/pharmacodynamics (PD) cohorts and in Part 2 must agree to undergo the mandatory fresh tumor biopsies, unless collection of the biopsy presents a safety risk

Exclusion criteria

• Less than 2 weeks between prior anticancer treatment (including radiotherapy) discontinuation and the first dose of study drug, and toxicities have not returned to Grade less than or equal to (<=) 1 or baseline
• Prior treatment with prostate-specific membrane antigen (PSMA)-targeted therapy except for PSMA-targeted vaccine is permitted
• Solid organ or bone marrow transplantation
• Seizure or known condition that may predispose to seizure or intracranial masses
• Other active malignancy requiring systemic treatment <=12 months prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Part 1: Dose Escalation

Experimental group

Description:

Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-63898081. Ascending dose levels will be sequentially tested.

Treatment:

Drug: JNJ-63898081

Part 2: Dose Expansion

Experimental group

Description:

Participants with mCRPC or renal cell carcinoma (RCC) will receive JNJ-63898081 at the recommended Phase 2 dose (RP2D) determined in Part 1.

Treatment:

Drug: JNJ-63898081