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

Neoplasms Clinical Trial

Official title:

A Phase 1, First-in-Human, Dose Escalation Study of JNJ-63898081, in Subjects With Advanced Stage Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926013
• Other study ID #: CR108593
• Secondary ID: 63898081EDI1001
• Status: Completed
• Phase: Phase 1
• Start date: May 1, 2019
• Est. completion date: September 2, 2021

Study information

• Verified date: November 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• JNJ-63898081
JNJ-63898081 will be administered.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
United States	NIH Clinical Center	Bethesda	Maryland
United States	Columbia University Medical Center	New York	New York
United States	University of Utah	Salt Lake City	Utah
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	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.	Approximately 3 years
Primary	Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)	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.	Approximately 3 years
Primary	Part 1: Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)	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.	Approximately 3 years
Secondary	Part 1 and Part 2: Serum Concentrations of JNJ-63898081	Serum samples will be analyzed to determine concentrations of JNJ-63898081 using a validated method.	Approximately 3 years
Secondary	Part 1 and 2: Systemic Cytokine Concentrations	A panel of cytokines, including those proinflammatory ones, will be measured.	Approximately 3 years
Secondary	Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies	Anti-JNJ-63898081 antibodies will be evaluated in serum samples collected from all participants.	Approximately 3 years
Secondary	Serum Prostate Specific Antigen (PSA) Concentration	Serum prostate specific antigen (PSA) concentration will be assessed.	Approximately 3 years
Secondary	Objective Response Rate (ORR)	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).	Approximately 3 years
Secondary	Duration of Response	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).	Approximately 3 years