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

NCT ID: NCT02671955

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-07-31

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.

Detailed Description

The purpose of this study is to see if JNJ-61610588 is safe and useful for treating participants with advanced cancer. This study consists of up to 4 parts. Part 1 will determine what dose of JNJ-61610588 can be given safely to advanced cancer participants. Part 2 will look at how participants with metastatic non-small cell lung cancer respond to a safe dose of JNJ-61610588. Parts 3 and 4 will test whether the dose of JNJ-61610588 identified in Part 1 is a safe and effective therapy for participants with specific types of advanced cancers (lung, pancreas, cervical, colorectal, head and neck). Participants will receive study drug in an outpatient setting. Participants safety will be monitored throughout the study.

Conditions

Advanced Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Dose Escalation

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.

Group Type: EXPERIMENTAL

JNJ-61610588

Intervention Type: DRUG

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

Part 2: Biomarker Evaluation

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.

Group Type: EXPERIMENTAL

JNJ-61610588

Intervention Type: DRUG

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

Part 3: Dose Expansion

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.

Group Type: EXPERIMENTAL

JNJ-61610588

Intervention Type: DRUG

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

Part 4: Dose Expansion

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

Group Type: EXPERIMENTAL

JNJ-61610588

Intervention Type: DRUG

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

Interventions

JNJ-61610588

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

New York, New York, United States

Philadelphia, Pennsylvania, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Countries

United States

Other Identifiers

61610588LUC1001

Identifier Type: OTHER

Identifier Source: secondary_id

2016-001903-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108083

Identifier Type: -

Identifier Source: org_study_id