A Phase 1 interventional study of JNJ-1761981 and Cetrelimab in Neoplasms, sponsored by Johnson & Johnson Enterprise Innovation Inc.. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Johnson & Johnson Enterprise Innovation Inc. (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 66 is close to the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Johnson & Johnson Enterprise Innovation Inc. is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive JNJ-1761981 intratumorally to determine a safe and tolerable total JNJ-1761981 dose.
Drug: JNJ-1761981
Participants in Cohort A will receive JNJ-1761981 at specified volumetric doses. Participants who receive more than 1 dose of JNJ-1761981 may receive optional systemic therapy with cetrelimab at the discretion of the treating physician.
Drug: JNJ-1761981 · Drug: Cetrelimab
JNJ-1761981 will be administered intratumorally.
Cetrelimab will be administered intravenously.
Also known as: JNJ-63723283
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
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
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).
Time frame: Up to approximately 2 years 10 months
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
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
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
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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