New chemo injection targets tumors directly in early trial
NCT ID NCT07525141
First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times
Summary
This early-stage study tests a chemotherapy drug (JNJ-1761981) that is injected directly into tumors in people with solid cancers that have not responded to standard treatments. The goal is to find a safe and effective dose, and to see if adding an immunotherapy (cetrelimab) helps shrink tumors. About 66 participants will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JNJ-1761981 (extended-release chemotherapy) and cetrelimab (immunotherapy)
- What this could lead to
- If it works, this could offer a new way to treat solid tumors by injecting chemotherapy directly into the tumor, potentially reducing side effects.
- What could go wrong
- This is an early Phase 1 trial with only 66 participants, focused on safety and dosing. It may not lead to an effective treatment, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Mayo Clinic Rochester
RECRUITINGRochester, Minnesota, 55905, United States
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Mayo Clinic in Florida
RECRUITINGJacksonville, Florida, 32224, United States
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Montefiore Medical Center
RECRUITINGThe Bronx, New York, 10467, United States
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