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

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: JNJ-61610588

Study type: Interventional

Funder types: Industry

Identifiers

NCT02671955

61610588LUC1001 (Other Identifier)

2016-001903-22 (EudraCT Number)

CR108083

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Part 1: Dose Escalation

Experimental group

Description:

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.

Treatment:

Drug: JNJ-61610588

Part 2: Biomarker Evaluation

Experimental group

Description:

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.

Treatment:

Drug: JNJ-61610588

Part 3: Dose Expansion

Experimental group

Description:

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.

Treatment:

Drug: JNJ-61610588

Part 4: Dose Expansion

Experimental group

Description:

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

Treatment:

Drug: JNJ-61610588