A Study of JNJ-1761981 in Participants With Solid Tumors

Phase 1RecruitingNCT07525141

Johnson & Johnson Enterprise Innovation Inc.66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

JNJ-1761981DRUG

JNJ-1761981 will be administered intratumorally.

CetrelimabDRUG

Cetrelimab will be administered intravenously.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Montefiore Medical Center

The Bronx, New York, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Part 1: Number of Participants with Adverse Events (AE) by Severity

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.

Time frame: Up to approximately 2 years 10 months

Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)

High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.

Time frame: Up to 28 days

Part 1: Number of Participants with AEs by Severity Related to Delivery Device and/or Procedure

Time frame: Up to approximately 2 years 10 months

Part 1: Number of Participants who Received Planned Total Dose per Level

Number of participants who received planned total dose per level will be reported.

Time frame: Up to approximately 28 days

Part 2: Administered Tumor Response Rate

Administered tumor response rate is defined as the percentage of JNJ-1761981 administered lesions that achieve complete response (CR) or partial response (PR).

Central Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Parts 1 and 2: Plasma Concentration of Free and Total Platinum

Plasma concentration of free and total platinum will be assessed.

Time frame: Up to approximately 2 years 10 months

Part 1: Administered Tumor Response Rate

Administered tumor response rate is defined as the percentage of JNJ-1761981 administered lesions that achieve CR or PR.

Time frame: Up to approximately 2 years 10 months

Parts 1 and 2: Administered Tumor Duration of Response

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.

Time frame: Up to approximately 2 years 10 months

Parts 1 and 2: Objective Response Rate (ORR)

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.

Time frame: Up to approximately 2 years 10 months

Parts 1 and 2: Disease Control Rate (DCR)

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.

Time frame: Up to approximately 2 years 10 months

Parts 1 and 2: Duration of Response (DOR)

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.

Time frame: Up to approximately 2 years 10 months

Part 2: Number of Participants with Adverse Events (AE) by Severity

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.

Time frame: Up to approximately 2 years 10 months

Part 2: Number of Participants with AE by Severity Related to Delivery Device and/or Procedure

Time frame: Up to approximately 2 years 10 months

Part 2: Number of Participants who Received Planned Intratumoral Volumetric Dose

Number of participants who received the planned intratumoral volumetric dose will be reported.

Time frame: Up to approximately 2 years 10 months