1761981STM1001
Advanced solid tumors
INTRATUMORAL STUDY.
A Phase 1, nonrandomized, open-label study of intratumoral administration of JNJ-1761981 ER (an extended-release chemotherapy) in participants with solid tumors
A Phase 1, nonrandomized, open-label study of intratumoral administration of JNJ-1761981 ER (an extended-release chemotherapy) in participants with solid tumors
Phase
Compound
JNJ-1761981 ER (an extended-release chemotherapy)Intratumoral study
NCT identifier
NCT07525141
Enrollment
N=~66
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- Part 1: Locally advanced or metastatic solid tumors that have progressed on standard therapies
- Part 2 Cohort A: Metastatic tumors of adenocarcinoma or squamous cell carcinoma histology, for which any platinum-based systemic regimen is considered a standard of care and whose disease has progressed after standard therapy
Study
design
Primary outcomes†:
Part 1
- Recommended total dose
- Safety
- DLTs
Part 2
- Administered tumor response rate
Secondary outcomes†:
- Plasma concentration of free and total platinum
- Administered tumor DOR
- ORR
- DCR
- DOR
Cetrelimab is an investigational anti–PD-1 monoclonal antibody.
*Not a complete list of inclusion and exclusion
criteria. †Not a complete list of outcomes.
DCR, disease control rate; DLT, dose-limiting toxicity;
DOR, duration of response; ER, extended-release; ORR, objective response rate; PD-1, programmed cell death protein
1; SOC, standard of care.