Clinical trial NCT03926013: A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors
Official title: A Phase 1, First-in-Human, Dose Escalation Study of JNJ-63898081, in Subjects With Advanced Stage Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Approximately 3 years
measure: Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
timeFrame: Approximately 3 years
measure: Part 1: Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
timeFrame: Approximately 3 years
Secondary outcomes:
measure: Part 1 and Part 2: Serum Concentrations of JNJ-63898081
timeFrame: Approximately 3 years
measure: Part 1 and 2: Systemic Cytokine Concentrations
timeFrame: Approximately 3 years
measure: Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies
timeFrame: Approximately 3 years
measure: Serum Prostate Specific Antigen (PSA) Concentration
timeFrame: Approximately 3 years
measure: Objective Response Rate (ORR)
timeFrame: Approximately 3 years
measure: Duration of Response
timeFrame: Approximately 3 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Bethesda
country: United States
facility: NIH Clinical Center
state: Maryland
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: