Advanced CancerPhase 1NCT02671955
A Study of Safety, Pharmacokinetics, Pharmacodynamics of JNJ-61610588 in Participants With Advanced Cancer
A Phase 1 study testing JNJ-61610588 in people with Advanced Cancer, run by Janssen Research & Development, LLC at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- JNJ-61610588
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2016to Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Houston, Texas
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Philadelphia, Pennsylvania
About this study
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
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.
Read the 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
- Being tested
- JNJ-61610588
- Keywords
- Advanced Cancer, JNJ-61610588
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-61610588Drug
Participants will receive intravenous infusions of JNJ-61610588 until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: JNJ-61610588 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 2.5 years
Secondary outcomes (8)
Maximum Serum Concentration (Cmax) of JNJ-61610588
The Cmax is the maximum observed serum concentration of JNJ-61610588.
Measured: Approximately 2.5 years
Elimination Half-Life (t1/2)
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Measured: Approximately 2.5 years
Area Under the Serum Concentration-Time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-61610588
The AUC(t1-t2) is the area under the serum JNJ-61610588 concentration-time curve from time t1 to t2.
Measured: Approximately 2.5 years
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Measured: Approximately 2.5 years
Number of Participants With Anti-JNJ-61610588 Antibodies
Plasma levels of antibodies to JNJ-61610588 for evaluation of potential immunogenicity.
Measured: Approximately 2.5 years
Assessment of Anti-Tumor Activity, as Assessed by the Overall Response Rate (ORR)
Anti-tumour activity as assessed by the ORR based on Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1.
Measured: Approximately 2.5 years
Assessment of Anti-Tumor Activity, as Assessed by the Overall Response Rate (ORR)
Anti-tumour activity as assessed by the ORR based on Immune-Related Response Criteria (irRC).
Measured: Approximately 2.5 years
Assessment of Anti-Tumor Activity, as Assessed by Duration of Response
Anti-tumour activity as assessed by the duration of response.
Measured: Approximately 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionJul 2017
Why it stopped: Janssen business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671955
- Sponsor's protocol ID
- CR108083
- Other IDs
- 61610588LUC1001, 2016-001903-22, 2016
- Status last verified
- Mar 2018
- First submitted
- 11 Jan 2016
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02671955
- Acronym / sponsor ID
- CR108083
- Conditions
- Advanced Cancer
- Keywords
- Advanced Cancer, JNJ-61610588
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Janssen business decision
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: JNJ-61610588Participants 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. |
| Part 2: Biomarker Evaluation | Experimental | Drug: JNJ-61610588Participants 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. |
| Part 3: Dose Expansion | Experimental | Drug: JNJ-61610588Participants 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. |
| Part 4: Dose Expansion | Experimental | Drug: JNJ-61610588Participants with advanced solid tumors will receive intravenous infusion of JNJ-61610588 at the recommended Phase 2 dose (RP2D) until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-61610588Participants will receive intravenous infusions of JNJ-61610588 until disease progression. | Drug | Part 1: Dose Escalation, Part 2: Biomarker Evaluation, Part 3: Dose Expansion, Part 4: Dose Expansion |
Primary outcome
Frequency of Dose Limiting Toxicity (DLT)
Time frame: Approximately 2.5 years
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.
Number of Participants with Adverse Events (AEs) and Serious AEs
Time frame: Approximately 2.5 years
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.
Change From Baseline in Pharmacodynamic Blood Biomarkers- Total Blood Cell Counts
Time frame: Approximately 2.5 years
Standard hematology laboratory tests will be used to evaluate total blood cell counts in blood samples collected pre- and posttreatment.
Change From Baseline in Pharmacodynamic Blood Biomarkers- Markers of Monocyte Activation
Time frame: Approximately 2.5 years
Flow cytometry will be used to evaluate markers of monocyte activation in blood samples collected pre- and posttreatment.
Change From Baseline in Pharmacodynamic Blood Biomarkers- Markers of T Cell Activation
Time frame: Approximately 2.5 years
Flow cytometry will be used to evaluate markers of T cell activation in blood samples collected pre- and posttreatment.
Change From Baseline in Pharmacodynamic Tissue Biomarkers- Protein Expression of VISTA (V-domain Ig suppressor of T cell activation)
Time frame: Approximately 2.5 years
Pre- and posttreatment tissue samples will be stained by immunohistochemistry for protein expression of VISTA.
Change From Baseline in Pharmacodynamic Tissue Biomarkers- Markers Associated With Immune Infiltrate Including CD3, CD4, CD8, Forkhead box P3, CD68, and PD-L1.
Time frame: Approximately 2.5 years
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.
8 secondary outcomes
Maximum Serum Concentration (Cmax) of JNJ-61610588
Time frame: Approximately 2.5 years
Elimination Half-Life (t1/2)
Time frame: Approximately 2.5 years
Area Under the Serum Concentration-Time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-61610588
Time frame: Approximately 2.5 years
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Time frame: Approximately 2.5 years
Number of Participants With Anti-JNJ-61610588 Antibodies
Time frame: Approximately 2.5 years
Assessment of Anti-Tumor Activity, as Assessed by the Overall Response Rate (ORR)
Time frame: Approximately 2.5 years
Assessment of Anti-Tumor Activity, as Assessed by the Overall Response Rate (ORR)
Time frame: Approximately 2.5 years
Assessment of Anti-Tumor Activity, as Assessed by Duration of Response
Time frame: Approximately 2.5 years
Results and safety
The study was stopped early (reason given: Janssen business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-61610588 in people with Advanced Cancer, run by Janssen Research & Development, LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Janssen business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Dose Limiting Toxicity (DLT) (time frame: Approximately 2.5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.