89862175LUC1001
Advanced solid tumors
A Phase 1 study to determine the safe and effective RP2D of JNJ-89862175
(ENPP3 ADC) in participants with advanced solid tumors
Phase
Compound
JNJ-89862175 (ENPP3 ADC)
NCT identifier
NCT07223125
Enrollment
N=~360
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*:
- Histologically or cytologically confirmed metastatic or unresectable solid tumor of one of the following types:
- RCC-clear cell or papillary carcinoma
- Lung adenocarcinoma
- Endometrioid uterine carcinoma
- Endometrioid ovarian cancer
- ECOG PS 0–1
- No active CNS involvement unless clinically stable
- No history of clinically significant CVD within 6 months prior to signing informed consent
- No history of solid organ or hematologic stem cell transplantation
Study
design
Primary outcomes:
Part 1
- DLTs
- AEs by severity
Part 2
- AEs by severity at RP2D
Secondary outcomes:
- ORR
- PFS
- DOR
- Plasma concentration for ADC, mAb, free payload and metabolite [Cmax, Ctrough Tmax , AUC, accumulation ratio]
- ADAs
*Not a complete list of inclusion and exclusion criteria.
ADA, anti-drug antibody; ADC, antibody-drug conjugate; AE, adverse event; CNS, central nervous system; Cmax, maximum plasma concentration; Ctrough, observed plasma concentration immediately before next dose administration; CVD, cardiovascular disease; DLT, dose-limiting toxicity; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; ENPP3, ectonucleotide pyrophosphatase/phosphodiesterase 3; mAb, monoclonal antibody; PFS, progression-free survival; PK, pharmacokinetics; PS, performance status; RCC, renal cell carcinoma; RP2D, recommended Phase 2 dose; Tmax, time to reach Cmax.