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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: JNJ-63898081

• Registration Number: NCT03926013
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-04-22
• Study First Posted: 2019-04-24
• Study Start: 2019-05-01
• Primary Completion: 2021-08-23
• Study Completion: 2021-09-02
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 2: Dose Expansion	JNJ-63898081	Participants with mCRPC or renal cell carcinoma (RCC) will receive JNJ-63898081 at the recommended Phase 2 dose (RP2D) determined in Part 1.
Part 1: Dose Escalation	JNJ-63898081	Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-63898081. Ascending dose levels will be sequentially tested.

Primary Outcome Measures

Name	Time	Method
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)	Approximately 3 years	Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	Approximately 3 years	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Part 1: Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)	Approximately 3 years	Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death.

Secondary Outcome Measures

Name	Time	Method
Part 1 and Part 2: Serum Concentrations of JNJ-63898081	Approximately 3 years	Serum samples will be analyzed to determine concentrations of JNJ-63898081 using a validated method.
Serum Prostate Specific Antigen (PSA) Concentration	Approximately 3 years	Serum prostate specific antigen (PSA) concentration will be assessed.
Objective Response Rate (ORR)	Approximately 3 years	ORR is defined as the proportion of participants who have a PR or better according to the disease-specific response criteria. Evaluation of prostate treatment response will be performed according to Prostate Cancer Working Group 3 (PCWG3).
Part 1 and 2: Systemic Cytokine Concentrations	Approximately 3 years	A panel of cytokines, including those proinflammatory ones, will be measured.
Duration of Response	Approximately 3 years	Duration of response (DOR) will be calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the disease-specific response criteria, or death due to any cause, whichever occurs first. Evaluation of prostate treatment response will be performed according to Prostate Cancer Working Group 3 (PCWG3).
Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies	Approximately 3 years	Anti-JNJ-63898081 antibodies will be evaluated in serum samples collected from all participants.

Trial Locations

Locations (7)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

British Columbia Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Columbia University Medical Center; 🇺🇸 New York, New York, United States

NIH Clinical Center; 🇺🇸 Bethesda, Maryland, United States