87704916LUC1001
Lung cancer
INTRATUMORAL STUDY.
A Phase 1, nonrandomized, open-label study of intratumoral administration of JNJ-87704916 (oncolytic virus) as monotherapy and in combination for advanced solid tumors/mNSCLC
A Phase 1, nonrandomized, open-label study of intratumoral administration of JNJ-87704916 (oncolytic virus) as monotherapy and in combination for advanced solid tumors/mNSCLC
Phase
Compound
JNJ-87704916 (oncolytic virus) ± cetrelimab (anti–PD-1 mAb)Intratumoral study
NCT identifier
NCT06311578
Enrollment
N=126
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: advanced solid tumors that have progressed on standard therapies
- Parts 1 and 2: ≥1 injectable lesion
- Parts 1 and 2: ECOG PS 0 or 1
- Parts 1 and 2: No active disease involvement of the CNS
- Parts 1 and 2: No prior history of, or active, significant herpetic infections that require ongoing systemic antiviral therapy
- Parts 1 and 2: No history of solid organ or HSC transplantation
Study
design
Primary outcomes:
- DLTs
- Safety
Secondary outcomes‡:
Part 1 and 2:
- ORR
- DC
- DOR
- PK
Part 2:
- PFS
- OS
*Not a complete list of inclusion and exclusion criteria. †Anti–PD(L)-1 antibody therapy in frontline
treatment of NSCLC. ‡Not a complete list of outcomes.
1L, first line; 2L, second line; CNS, central
nervous system; DC, disease control; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern
Cooperative Oncology Group performance status; HSC, hematopoietic stem cell; IT, intratumoral; mAb, monoclonal
antibody; mNSCLC, metastatic NSCLC; NSCLC, non–small cell lung cancer; ORR, objective response rate; OS, overall
survival; PD-1, programmed cell death protein 1; PFS, progression-free survival; PK, pharmacokinetics; SOC, standard
of care.