About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

JNJ-1761981
Drug
JNJ-1761981 will be administered intratumorally.
Cetrelimab
Drug
Cetrelimab will be administered intravenously.

Treatment groups

66 Participants

are divided into 2 treatment groups

Group A: Part 1: Dose EscalationExperimental treatment 1 intervention

Group B: Part 2: Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

2

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

3

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

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.

Time frame

Up to approximately 2 years 10 months

4

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

Secondary outcomes

1

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

2

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

3

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

4

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

A Study of JNJ-1761981 in Participants With Solid Tumors

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts