A Study of JNJ-1761981 in Participants With Solid Tumors
This study is testing two drugs, JNJ-1761981 and Cetrelimab, in people with solid tumors (cancers that form solid masses). JNJ-1761981 will be given directly into the tumor, and Cetrelimab will be given through a vein. The main goals of the study are to find a safe and tolerable dose of JNJ-1761981 and to figure out the best amount of JNJ-1761981 to treat tumors. You may be able to join if you have locally advanced or metastatic (spread to other parts of the body) solid tumors, have already tried standard treatments, or cannot tolerate them. The study is currently unclear on its recruitment status and plans to enroll 66 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 66 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events (side effects) for up to approximately 2 years and 10 months.
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A Study of JNJ-1761981 in Participants With Solid Tumors
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Johnson & Johnson Enterprise Innovation, Inc Clinical Trial · STUDY_DIRECTOR · Johnson & Johnson Enterprise Innovation Inc.
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Part 1: Number of Participants with Adverse Events (AE) by SeverityUp 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.
- Part 1: Number of Participants with AEs by Severity Related to Delivery Device and/or ProcedureUp 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 LevelUp to approximately 28 days
Number of participants who received planned total dose per level will be reported.
- Part 2: Administered Tumor Response RateUp 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).