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

• Status: Terminated
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

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