Neoplasms
Conditions
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.
Interventions
DRUGJNJ-1761981
JNJ-1761981 will be administered intratumorally.
DRUGCetrelimab
Cetrelimab will be administered intravenously.
Sponsors
Johnson & Johnson Enterprise Innovation Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants with AEs by Severity Related to Delivery Device and/or Procedure | Up to approximately 2 years 10 months | 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. |
| Part 1: Number of Participants who Received Planned Total Dose per Level | Up to approximately 28 days | Number of participants who received planned total dose per level will be reported. |
| Part 2: Administered Tumor Response Rate | Up to approximately 2 years 10 months | Administered tumor response rate is defined as the percentage of JNJ-1761981 administered lesions that achieve complete response (CR) or partial response (PR). |
| Part 1: Number of Participants with Adverse Events (AE) by Severity | Up to approximately 2 years 10 months | 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. |
| Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs) | Up to 28 days | High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parts 1 and 2: Objective Response Rate (ORR) | Up to approximately 2 years 10 months | 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. |
| Parts 1 and 2: Disease Control Rate (DCR) | Up to approximately 2 years 10 months | 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. |
| Parts 1 and 2: Duration of Response (DOR) | Up to approximately 2 years 10 months | 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. |
| Part 2: Number of Participants with AE by Severity Related to Delivery Device and/or Procedure | Up to approximately 2 years 10 months | 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. |
| Part 2: Number of Participants with Adverse Events (AE) by Severity | Up to approximately 2 years 10 months | 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. |
| Part 2: Number of Participants who Received Planned Intratumoral Volumetric Dose | Up to approximately 2 years 10 months | Number of participants who received the planned intratumoral volumetric dose will be reported. |
| Parts 1 and 2: Plasma Concentration of Free and Total Platinum | Up to approximately 2 years 10 months | Plasma concentration of free and total platinum will be assessed. |
| Part 1: Administered Tumor Response Rate | Up to approximately 2 years 10 months | Administered tumor response rate is defined as the percentage of JNJ-1761981 administered lesions that achieve CR or PR. |
| Parts 1 and 2: Administered Tumor Duration of Response | Up to approximately 2 years 10 months | 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. |
Countries
United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJohnson & Johnson Enterprise Innovation, Inc Clinical Trial
Johnson & Johnson Enterprise Innovation Inc.
Outcome results
None listed