Table 1.
Ongoing clinical trials evaluating new antibody–drug conjugates in breast cancer monotherapy in HR + BC.
Antibody-Drug Conjugate | Payload | Linker | Trial | Population | Phase | Status |
---|---|---|---|---|---|---|
HER 2 | ||||||
Vic-trastuzumab duocarmazine (SYD985) | duocarmycin (DNA alkylator) | cleavable | NCT04602117 | HER2-positive advanced solid tumors or HER2-low breast cancer | 1 | recruiting |
MRG002 | MMAE | cleavable vc-linker | NCT05263869 | HER2-positive BC with liver metastases | 2 | recruiting |
NCT04924699 | HER2-positive unresectable locally advanced or metastatic BC | 2 | recruiting | |||
NCT04742153 | HER2-low, locally advanced or mBC | 2 | recruiting | |||
Disitamab-vedotin (RC48) | MMAE | cleavable | NCT04400695 | locally advanced or HER2-low mBC | 3 | recruiting |
NCT03052634 | advanced BC with HER2-positive or low HER2 expression | 1–3 | active, not recruiting | |||
HER3 | ||||||
Antibody–drug conjugate | payload | linker | trial | population | Phase | Status |
Patritumab deruxtecan | exatecan derivative | tetrapeptide-based | NCT04965766 | first-line HER3-high, HER2−, HR+ unresectable locally advanced BC or mBC | 2 | recruiting |
NCT04610528 | HR+/HER2− tumor with non-metastatic primary invasive BC, untreated and recently diagnosed | 1 | recruiting | |||
TROP2 | ||||||
Antibody–drug conjugate | payload | linker | trial | population | Phase | Status |
Datopotamab deruxtecan | deruxtecan | tetrapeptide-based cleavable linker | NCT05104866 (TROPION-Breast01) | inoperable or metastatic HR+/HER2 − BC | 3 | recruiting |
Nectin-4 | ||||||
Antibody–drug conjugate | payload | linker | trial | population | Phase | Status |
Enfortumab vedotin | MMAE | protease-cleavable | NCT04225117 | treatment of refractory advanced solid tumors (HR+/HER2− or TNBC) | 2 | active, not recruiting |
FRα | ||||||
Antibody–drug conjugate | payload | linker | trial | population | Phase | Status |
PRO1184 | exatecan, a topoisomerase 1 inhibitor | cleavable | NCT05579366 | advanced and/or metastatic solid tumors (TNBC, HR+, and HER2+) | 1–2 | recruiting |