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| ID | Type | Description | Link |
|---|---|---|---|
| 61610588LUC1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2016-001903-22 | EudraCT Number |
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Janssen business decision
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-61610588 | Drug | Participants will receive intravenous infusions of JNJ-61610588 until disease progression. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Approximately 2.5 years |
| Change From Baseline in Pharmacodynamic Tissue Biomarkers- Protein Expression of VISTA (V-domain Ig suppressor of T cell activation) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration (Cmax) of JNJ-61610588 | The Cmax is the maximum observed serum concentration of JNJ-61610588. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York | New York | United States | ||||
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Pre- and posttreatment tissue samples will be stained by immunohistochemistry for protein expression of VISTA. |
| 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. | Approximately 2.5 years |
| 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. | 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. | Approximately 2.5 years |
| Number of Participants With Anti-JNJ-61610588 Antibodies | Plasma levels of antibodies to JNJ-61610588 for evaluation of potential immunogenicity. | 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. | 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). | 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. | Approximately 2.5 years |
| Philadelphia |
| Pennsylvania |
| United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |