A Study of Safety, Pharmacokinetics, Pharmacodynamics of JNJ-61610588 in Participants With Advanced Cancer

NCT02671955 | Terminated Phase 1

• 3 other identifiers: CR10808361610588LUC10012016-001903-22
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of JNJ-61610588 in participants with advanced cancer in order to determine a recommended Phase 2 dose (RP2D) for further evaluation in specific tumor types.

Conditions

Advanced Cancer

Keywords

Advanced Cancer; JNJ-61610588

Outcome Measures

Primary Outcomes (7)

• Frequency of Dose Limiting Toxicity (DLT)

  The Dose Limiting Toxicity (DLT) is based on adverse events and includes unacceptable hematologic toxicity, unacceptable non-hematologic toxicity of Grade 3 or higher, and treatment delay greater than 2 weeks.

  Approximately 2.5 years

• Number of Participants with Adverse Events (AEs) and Serious AEs

  An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Approximately 2.5 years

• Change From Baseline in Pharmacodynamic Blood Biomarkers- Total Blood Cell Counts

  Standard hematology laboratory tests will be used to evaluate total blood cell counts in blood samples collected pre- and posttreatment.

  Approximately 2.5 years

• Change From Baseline in Pharmacodynamic Blood Biomarkers- Markers of Monocyte Activation

  Flow cytometry will be used to evaluate markers of monocyte activation in blood samples collected pre- and posttreatment.

  Approximately 2.5 years

• Change From Baseline in Pharmacodynamic Blood Biomarkers- Markers of T Cell Activation

  Flow cytometry will be used to evaluate markers of T cell activation in blood samples collected pre- and posttreatment.

  Approximately 2.5 years

• Change From Baseline in Pharmacodynamic Tissue Biomarkers- Protein Expression of VISTA (V-domain Ig suppressor of T cell activation)

  Pre- and posttreatment tissue samples will be stained by immunohistochemistry for protein expression of VISTA.

  Approximately 2.5 years

• Change From Baseline in Pharmacodynamic Tissue Biomarkers- Markers Associated With Immune Infiltrate Including CD3, CD4, CD8, Forkhead box P3, CD68, and PD-L1.

  Pre- and posttreatment tissue samples will be stained by immunohistochemistry for markers associated with immune infiltrate including CD3, CD4, CD8, forkhead box P3, CD68, and PD-L1.

  Approximately 2.5 years

Secondary Outcomes (8)

• Maximum Serum Concentration (Cmax) of JNJ-61610588

  Approximately 2.5 years

• Elimination Half-Life (t1/2)

  Approximately 2.5 years

• Area Under the Serum Concentration-Time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-61610588

  Approximately 2.5 years

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])

  Approximately 2.5 years

• Number of Participants With Anti-JNJ-61610588 Antibodies

  Approximately 2.5 years

Study Arms (4)

Part 1: Dose Escalation

EXPERIMENTAL

Participants with advanced solid tumors will receive intravenous infusions of JNJ-61610588 until disease progression. Dose escalation will continue until the maximum tolerated dose is reached.

Drug: JNJ-61610588

Part 2: Biomarker Evaluation

EXPERIMENTAL

Participants with metastatic Non-small Cell Lung Cancer (NSCLC) will receive intravenous infusion of JNJ-61610588 at or below the recommended Phase 2 dose (RP2D) until disease progression.

Drug: JNJ-61610588

Part 3: Dose Expansion

EXPERIMENTAL

Participants with metastatic Non-small Cell Lung Cancer (NSCLC) will receive intravenous infusion of JNJ-61610588 at the recommended Phase 2 dose (RP2D) until disease progression.

Drug: JNJ-61610588

Part 4: Dose Expansion

EXPERIMENTAL

Participants with advanced solid tumors will receive intravenous infusion of JNJ-61610588 at the recommended Phase 2 dose (RP2D) until disease progression.

Drug: JNJ-61610588

Interventions

JNJ-61610588 DRUG

Participants will receive intravenous infusions of JNJ-61610588 until disease progression.

Part 1: Dose Escalation; Part 2: Biomarker Evaluation; Part 3: Dose Expansion; Part 4: Dose Expansion

Eligibility Criteria

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

You may qualify if:

• The participant has a solid tumor. Parts 2 and 3 are limited to participants with non-small cell lung cancer. Part 4 is limited to participants with small cell lung, head and neck, pancreatic, colorectal, and cervical cancers
• Tumor progression following at least one prior standard therapy
• The participant has a radiographically measurable tumor. Evaluable disease is acceptable for Part 1 only
• The participant is willing to consent to provide a tumor tissue sample (fresh biopsy) before (Parts 2 and 3) and after (Part 2 only) receiving the study drug
• The participant is able to carry out daily life activities without difficulty
• The participant does not have significant side effects from previous anti-cancer treatment
• The participant has adequate organ and blood cell counts
• Sexually active participants must use medically acceptable methods of contraception during the course of this study

You may not qualify if:

• The participant has a history of major surgery or treatment other cancer therapy within 2-6 weeks before starting the study
• The participant has an untreated brain tumor
• Current severe, uncontrolled systemic disease including an ongoing, active infection requiring treatment with antibiotics
• The participant has high blood pressure or diabetes that is not well-controlled with medication
• History of clinically significant heart problems
• History of severe side effects toimmunotherapy
• The participant is pregnant, breastfeeding, or planning to become pregnant or father a child
• Positive for Hepatitis B, Hepatitis C, or HIV
• The participant has received anticoagulant therapy with the exception of aspirin within 1 week of starting the study

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (4)

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Houston, Texas, United States

Location

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: February 2, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

US (4)