Clinical trial NCT02671955: A Study of Safety, Pharmacokinetics, Pharmacodynamics of JNJ-61610588 in Participants With Advanced Cancer
Official title: An Open-label, First-in-Human, Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-61610588, a Fully Human IgG1 Kappa Anti-VISTA (V-domain Ig Suppressor of T-cell Activation) Monoclonal Antibody, in Subjects With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: Advanced Cancer
JNJ-61610588
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-02-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency of Dose Limiting Toxicity (DLT)
timeFrame: Approximately 2.5 years
measure: Number of Participants with Adverse Events (AEs) and Serious AEs
timeFrame: Approximately 2.5 years
measure: Change From Baseline in Pharmacodynamic Blood Biomarkers- Total Blood Cell Counts
timeFrame: Approximately 2.5 years
measure: Change From Baseline in Pharmacodynamic Blood Biomarkers- Markers of Monocyte Activation
timeFrame: Approximately 2.5 years
measure: Change From Baseline in Pharmacodynamic Blood Biomarkers- Markers of T Cell Activation
timeFrame: Approximately 2.5 years
measure: Change From Baseline in Pharmacodynamic Tissue Biomarkers- Protein Expression of VISTA (V-domain Ig suppressor of T cell activation)
timeFrame: Approximately 2.5 years
measure: Change From Baseline in Pharmacodynamic Tissue Biomarkers- Markers Associated With Immune Infiltrate Including CD3, CD4, CD8, Forkhead box P3, CD68, and PD-L1.
timeFrame: Approximately 2.5 years
Secondary outcomes:
measure: Maximum Serum Concentration (Cmax) of JNJ-61610588
timeFrame: Approximately 2.5 years
measure: Elimination Half-Life (t1/2)
timeFrame: Approximately 2.5 years
measure: Area Under the Serum Concentration-Time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-61610588
timeFrame: Approximately 2.5 years
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
timeFrame: Approximately 2.5 years
measure: Number of Participants With Anti-JNJ-61610588 Antibodies
timeFrame: Approximately 2.5 years
measure: Assessment of Anti-Tumor Activity, as Assessed by the Overall Response Rate (ORR)
timeFrame: Approximately 2.5 years
measure: Assessment of Anti-Tumor Activity, as Assessed by the Overall Response Rate (ORR)
timeFrame: Approximately 2.5 years
measure: Assessment of Anti-Tumor Activity, as Assessed by Duration of Response
timeFrame: Approximately 2.5 years
Other outcomes:
Locations:
city: New York
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: