Brief Summary
The purpose of Part 1 of this study is to determine a safe, tolerable, and feasible recommended total dose of intratumorally administered JNJ-1761981. The purpose of Part 2 of this study is to identify the optimal volumetric dose of JNJ-1761981 for the treatment of tumor lesions.
Brief Title
A Study of JNJ-1761981 in Participants With Solid Tumors
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
844-434-4210
Central Contact Email
Participate-In-This-Study1@its.jnj.com
Completion Date
Completion Date Type
Estimated
Conditions
Neoplasms
Eligibility Criteria
Inclusion criteria:
* Part 1: Individuals with a diagnosis of locally advanced or metastatic disease (solid tumors except tumors of the central nervous system \[CNS\]) who have previously received available standard therapy and progressed, or cannot tolerate standard therapy, or for whom there is no standard of care per regional guidelines
* Part 2 Cohort A: Individuals with histologically or cytologically confirmed metastatic tumors of adenocarcinoma or squamous cell carcinoma histology, for which any platinum-based systemic regimen is considered a standard of care (per national comprehensive cancer network \[NCCN\] guidelines) and whose disease has progressed after standard therapy
* Eastern cooperative oncology group performance status (ECOG) performance status of Grade 0 or 1
* Part 2 Cohort A participants planned to receive optional cetrelimab (participants not meeting this criterion may still be enrolled in the study but cannot receive cetrelimab): Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy
* A participant of childbearing potential must practice at least 2 highly effective methods of contraception throughout the study and through 14 months (for women) and 11 months (for men) after the last dose of JNJ-1761981 or 5 months after the last dose of cetrelimab or other anti-PD(L)1 treatment, whichever is later
Exclusion criteria:
* Active symptomatic disease involvement of the central nervous system
* Prior or concurrent second malignancy (other than the disease under study) that due to natural history or treatment is likely to interfere with any study endpoints of safety or the antitumor activity of the study treatment(s)
* Active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures
* Known allergies, hypersensitivity, or intolerance to JNJ-1761981 or its excipients
* Lesions invading or adjacent to major blood vessels or other critical structures (for example, airways) not suitable for injection
* Part 1: Individuals with a diagnosis of locally advanced or metastatic disease (solid tumors except tumors of the central nervous system \[CNS\]) who have previously received available standard therapy and progressed, or cannot tolerate standard therapy, or for whom there is no standard of care per regional guidelines
* Part 2 Cohort A: Individuals with histologically or cytologically confirmed metastatic tumors of adenocarcinoma or squamous cell carcinoma histology, for which any platinum-based systemic regimen is considered a standard of care (per national comprehensive cancer network \[NCCN\] guidelines) and whose disease has progressed after standard therapy
* Eastern cooperative oncology group performance status (ECOG) performance status of Grade 0 or 1
* Part 2 Cohort A participants planned to receive optional cetrelimab (participants not meeting this criterion may still be enrolled in the study but cannot receive cetrelimab): Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy
* A participant of childbearing potential must practice at least 2 highly effective methods of contraception throughout the study and through 14 months (for women) and 11 months (for men) after the last dose of JNJ-1761981 or 5 months after the last dose of cetrelimab or other anti-PD(L)1 treatment, whichever is later
Exclusion criteria:
* Active symptomatic disease involvement of the central nervous system
* Prior or concurrent second malignancy (other than the disease under study) that due to natural history or treatment is likely to interfere with any study endpoints of safety or the antitumor activity of the study treatment(s)
* Active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures
* Known allergies, hypersensitivity, or intolerance to JNJ-1761981 or its excipients
* Lesions invading or adjacent to major blood vessels or other critical structures (for example, airways) not suitable for injection
Inclusion Criteria
Inclusion criteria:
* Part 1: Individuals with a diagnosis of locally advanced or metastatic disease (solid tumors except tumors of the central nervous system \[CNS\]) who have previously received available standard therapy and progressed, or cannot tolerate standard therapy, or for whom there is no standard of care per regional guidelines
* Part 2 Cohort A: Individuals with histologically or cytologically confirmed metastatic tumors of adenocarcinoma or squamous cell carcinoma histology, for which any platinum-based systemic regimen is considered a standard of care (per national comprehensive cancer network \[NCCN\] guidelines) and whose disease has progressed after standard therapy
* Eastern cooperative oncology group performance status (ECOG) performance status of Grade 0 or 1
* Part 2 Cohort A participants planned to receive optional cetrelimab (participants not meeting this criterion may still be enrolled in the study but cannot receive cetrelimab): Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy
* A participant of childbearing potential must practice at least 2 highly effective methods of contraception throughout the study and through 14 months (for women) and 11 months (for men) after the last dose of JNJ-1761981 or 5 months after the last dose of cetrelimab or other anti-PD(L)1 treatment, whichever is later
* Part 1: Individuals with a diagnosis of locally advanced or metastatic disease (solid tumors except tumors of the central nervous system \[CNS\]) who have previously received available standard therapy and progressed, or cannot tolerate standard therapy, or for whom there is no standard of care per regional guidelines
* Part 2 Cohort A: Individuals with histologically or cytologically confirmed metastatic tumors of adenocarcinoma or squamous cell carcinoma histology, for which any platinum-based systemic regimen is considered a standard of care (per national comprehensive cancer network \[NCCN\] guidelines) and whose disease has progressed after standard therapy
* Eastern cooperative oncology group performance status (ECOG) performance status of Grade 0 or 1
* Part 2 Cohort A participants planned to receive optional cetrelimab (participants not meeting this criterion may still be enrolled in the study but cannot receive cetrelimab): Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy
* A participant of childbearing potential must practice at least 2 highly effective methods of contraception throughout the study and through 14 months (for women) and 11 months (for men) after the last dose of JNJ-1761981 or 5 months after the last dose of cetrelimab or other anti-PD(L)1 treatment, whichever is later
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07525141
Org Class
Industry
Org Full Name
Johnson & Johnson Enterprise Innovation Inc.
Org Study Id
1761981STM1001
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Phase 1 Study of Intratumoral Administration of JNJ-1761981 ER, an Extended Release Chemotherapy, in Participants With Solid Tumors
Primary Outcomes
Outcome Description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.
Outcome Measure
Part 1: Number of Participants with Adverse Events (AE) by Severity
Outcome Time Frame
Up to approximately 2 years 10 months
Outcome Description
High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.
Outcome Measure
Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)
Outcome Time Frame
Up to 28 days
Outcome Description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Participants with AEs related to delivery device and/or procedure will be reported.
Outcome Measure
Part 1: Number of Participants with AEs by Severity Related to Delivery Device and/or Procedure
Outcome Time Frame
Up to approximately 2 years 10 months
Outcome Description
Number of participants who received planned total dose per level will be reported.
Outcome Measure
Part 1: Number of Participants who Received Planned Total Dose per Level
Outcome Time Frame
Up to approximately 28 days
Outcome Description
Administered tumor response rate is defined as the percentage of JNJ-1761981 administered lesions that achieve complete response (CR) or partial response (PR).
Outcome Measure
Part 2: Administered Tumor Response Rate
Outcome Time Frame
Up to approximately 2 years 10 months
Secondary Ids
Secondary Id
1761981STM1001
Secondary Outcomes
Outcome Description
Plasma concentration of free and total platinum will be assessed.
Outcome Time Frame
Up to approximately 2 years 10 months
Outcome Measure
Parts 1 and 2: Plasma Concentration of Free and Total Platinum
Outcome Description
Administered tumor response rate is defined as the percentage of JNJ-1761981 administered lesions that achieve CR or PR.
Outcome Time Frame
Up to approximately 2 years 10 months
Outcome Measure
Part 1: Administered Tumor Response Rate
Outcome Description
Administered tumor duration of response will be calculated among JNJ-1761981 administered lesions that responded from the date of initial documentation of lesion response to the date of first documented evidence of progression or start of subsequent anticancer treatment or death due to any cause, whichever occurs first.
Outcome Time Frame
Up to approximately 2 years 10 months
Outcome Measure
Parts 1 and 2: Administered Tumor Duration of Response
Outcome Description
ORR is defined as the percentage of participants who have best response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Outcome Time Frame
Up to approximately 2 years 10 months
Outcome Measure
Parts 1 and 2: Objective Response Rate (ORR)
Outcome Description
DCR is defined as the percentage of participants who have achieved CR, PR, and stable disease for at least 4 weeks after study treatment was administered.
Outcome Time Frame
Up to approximately 2 years 10 months
Outcome Measure
Parts 1 and 2: Disease Control Rate (DCR)
Outcome Description
DOR will be calculated among responders from the date of initial documentation of a response (first CR/PR) to the date of first documented evidence of progression according to RECIST v.1.1, or death due to any cause, whichever occurs first.
Outcome Time Frame
Up to approximately 2 years 10 months
Outcome Measure
Parts 1 and 2: Duration of Response (DOR)
Outcome Description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the NCI-CTCAE v 5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.
Outcome Time Frame
Up to approximately 2 years 10 months
Outcome Measure
Part 2: Number of Participants with Adverse Events (AE) by Severity
Outcome Description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Participants with AEs related to delivery device and/or procedure will be reported.
Outcome Time Frame
Up to approximately 2 years 10 months
Outcome Measure
Part 2: Number of Participants with AE by Severity Related to Delivery Device and/or Procedure
Outcome Description
Number of participants who received the planned intratumoral volumetric dose will be reported.
Outcome Time Frame
Up to approximately 2 years 10 months
Outcome Measure
Part 2: Number of Participants who Received Planned Intratumoral Volumetric Dose
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Eric Feldman
Investigator Email
efeldman@montefiore.org
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Please Specify
Categories Mesh Debug
Cancer --- NEOPLASMS
MeSH Terms
NEOPLASMS