HLD-0117-ONC-101
Advanced solid tumors
A Phase 1, open-label study of JNJ-101684362* in participants with ER+ MBC or locally advanced BC that have progressed on prior systemic therapies
Phase
Compound
JNJ-101684362*
NCT identifier
NCT07524855
Enrollment
N=~33
For more information, including
contact details, please visit
ClinicalTrials.gov
contact details, please visit
ClinicalTrials.gov
Study overview & design
Key eligibility criteria†:
- Metastatic or locally advanced BC
- Postmenopausal status defined by surgical or natural menopause, or ovarian suppression with a GnRH agonist
- Prior treatment including ≥1 endocrine therapy in the metastatic setting, ≥1 CDK4/6 inhibitor (in the adjuvant and/or metastatic setting), and ≤2 prior cytotoxic regimens in the metastatic setting
- Radiologic disease progression on the most recent therapy
- ER+ and HER2- status documented within 2 years
- ECOG PS 0 or 1
Study
design
Primary outcomes:
- DLTs
- AEs
Secondary outcomes:
- ORR
- DOR
- rPFS
- DCR
*Other name: HLD-0117. †Not a complete list of inclusion and exclusion criteria.
AE, adverse event; BC, breast cancer; CDK4/6, cyclin-dependent kinase 4 and 6; DCR, disease control rate; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ER+, estrogen receptor positive; GnRH, gonadotropin releasing hormone; HER2-, human epidermal growth factor receptor negative; MBC, metastatic breast cancer; ORR, objective response rate; rPFS, radiographic progression-free survival.