Table 3.
Antibody Drug-Conjugates against HER3 under clinical development
| Study population | Clinical Trial, phase | Adverse events | Status, conclusion (references) |
|---|---|---|---|
| U3-1402 (Patritumab deruxtecan, HER3-DXd) | |||
| Advanced or metastatic CRC | NCT04479436, phase II | Terminated (Study was terminated early given the Interim Analysis for Part 1 (signal finding) did not meet pre-specified criteria and will not proceed to Part 2. Sponsor will proceed closing the study). No results posted | |
| Naïve patients with HR + /HER2- early BC | NCT04610528, phase I | Recruiting | |
| Metastatic or unresectable NSCLC | NCT03260491, phase I | Nausea, vomiting, fatigue, decreased appetite and alopecia |
Recruiting U3-1402 has antitumor activity and manageable safety profile [240, 241, 244] |
| HER3 + metastatic BC | NCT02980341, phase I + II | Nausea, vomiting and decreased appetite |
Active, not recruiting In a preliminary analysis, U3-1402 demonstrated antitumor activity and manageable safety profile [242, 245] |
| Metastatic or locally advanced EGFR-mutated NSCLC | NCT04619004, phase II | Recruiting | |
| Locally advanced or metastatic EGFR-mutated NSCLC | NCT04676477, phase I | Recruiting | |
| Metastatic BC | NCT04699630, phase II | Recruiting | |
| Advanced BC | NCT04965766, phase II | Recruiting | |
| Metastatic or locally advanced EGFR-mutated NSCLC after failure of EGFR TKI therapy | NCT05338970, phase III | Recruiting | |