HER2-Positive Solid Tumor Clinical Trial
Official title:
A Phase 1/2, Non-randomized, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32367 in Patients With HER2-Positive Locally Advanced or Metastatic Solid Tumors
This first-in-human study will be counducted to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors.
YH32367, a novel HER2/4-1BB bispecific antibody (BsAb), simultaneously targets HER2 and h4-1BB and binds to both targets. YH32367 exhibits a strong 4-1BB signal activation as well as blocking of HER signaling in HER2-expressing tumor cells. YH32367 stimulats IFN-γ secretion from T cells and thereby inducing tumor cells lysis. This is a Phase 1/2, non-randomized, open-label, multicenter, first-in-human study of YH32367. This 2-part study will include both a Dose Escalation part, to identify the Maximum Tolerated Dose (MTD) or the RP2D of YH32367, and a Dose Expansion part, to confirm the safety, tolerability and efficacy of YH32367 at the RP2D. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03330561 -
PRS-343 in HER2-Positive Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT04757090 -
89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
|
Phase 2 | |
| Completed |
NCT03650348 -
PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors
|
Phase 1 |