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

NCT03926013 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10859363898081EDI1001
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 7

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Part 1 and Part 2: Serum Concentrations of JNJ-63898081

  Approximately 3 years

• Part 1 and 2: Systemic Cytokine Concentrations

  Approximately 3 years

• Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies

  Approximately 3 years

• Serum Prostate Specific Antigen (PSA) Concentration

  Approximately 3 years

• Objective Response Rate (ORR)

  Approximately 3 years

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

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

Drug: JNJ-63898081

Part 2: Dose Expansion

EXPERIMENTAL

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

Drug: JNJ-63898081

Interventions

JNJ-63898081 DRUG

JNJ-63898081 will be administered.

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (7)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

NIH Clinical Center

Bethesda, Maryland, 20892, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Washington

Seattle, Washington, 98195-9472, United States

Location

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z4E6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 24, 2019
• Study Start: May 1, 2019
• Primary Completion: August 23, 2021
• Study Completion: September 2, 2021
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (5); CA (2)