Table 1.
Novel ADCs Combination Trials.
| ADC | ADC Target | Trials | Phase | Combination Therapy | Patient Population | Key Objective | NCT No. |
|---|---|---|---|---|---|---|---|
| Trastuzumab Emtansine (T-DM1) |
HER2 | KATE2 | II | T-DM1+ atezolizumab | 2L HER2+ MBC | PFS | NCT02924883 |
| CompassHER2 RD | III | T-DM1 + tucatinib | HER2+ stage II–III with residual disease after neoadjuvant treatment | iDFS | NCT04457596 | ||
| Trastuzumab deruxtecan (T-DXd) |
HER2 | DESTINY Breast-08 | IB/II | Capivasertib, Anastrozole, fulvestrant | 1–2L HER-2 low MBC | AEs | NCT04556773 |
| TALENT | II | Anastrozole | Neoadjuvant HER2-low HR+ | pCR | NCT04553770 | ||
| DASH | I | AZD6738 | HER2+ advanced solid tumor | RP2D | NCT04704661 | ||
| I | Nivolumab | Advanced breast or urothelial Ca | DLT, ORR | NCT03523572 | |||
| IB | Pembrolizumab | Advanced breast cancer or NSCLC | DLT, ORR | NCT04042701 | |||
| DESTINY Breast-07 | I/II | Durvalumab or pertuzumab, or paclitaxel +/− durvalumab or tucatinib |
HER2+ MBC | AEs | NCT04538742 | ||
| Disitamab vedotin (RC48-ADC) |
HER2 | ROSY | III | Endocrine therapy | 1st line endocrine resistant HER2-low MBC | PFS | NCT05904964 |
| I | Penpulimab (AK105) |
Neoadjuvant HER2-low BC | pCR | NCT05726175 | |||
| ARX-788 | HER2 | II | Pyrotinib (HER2 TKI) |
Neoadjuvant stage II–III HER2+ BC |
RCB | NCT04983121 | |
| ISPY-2.2 | II | Cemiplimab | Neoadjuvant stage I–III HER2+ BC |
pCR | NCT01042379 | ||
| Sacituzumab Govitecan | TROP-2 | ASCENT05 | III | Pembrolizumab | Post-neoadjuvant stage I–III TNBC with residual disease | iDFS | NCT05633654 |
| ASCENT04 | III | Pembrolizumab | 1st line PD-L1+ metastatic TNBC | PFS | NCT05382286 | ||
| ASSET | I | Alpelisib | 2+L HER2+ MBC | RP2D | NCT05143229 | ||
| I/II | Talazoparib | Metastatic TNBC | DLT | NCT04039230 | |||
| I | GS9716 (Mcl-1 antagonist) |
Advanced solid tumors including MBC | DLT | NCT05006794 | |||
| Dato-DXd | TROP-2 | TROPION Breast 03 | III | Durvalumab | Post-neoadjuvant stage I–III TNBC with residual disease | iDFS | NCT05629585 |
| ISPY-2.2 | II | Durvalumab | Neoadjuvant stage I–III TNBC | pCR | NCT01042379 | ||
| PETRA | I/II | AZD5305 (PARPi) | Advanced solid tumor including breast cancer | DTL | NCT04644068 | ||
| Ladiratuzumab vedotin (SGN-LIV1A) |
LIV-1 | MORPHEUS-panBC | II | Atezolizumab | Metastatic or Locally Advanced Breast Cancer | ORR | NCT03424005 |
| SGNLVA-002 Or KEYNOTE 721 |
I/II | Pembrolizumab | Advanced TNBC | ORR | NCT03310957 | ||
| Patritumab Deruxtecan | HER3 | VALENTINE | II | Endocrine therapy | Neoadjuvant high risk HR+/HER2− Early Stage BC |
pCR | NCT05569811 |
PFS: progression-free survival; iDFS: invasive disease-free survival; AEs: adverse events; pCR: pathologic complete response; PR2D: recommended phase II dose; DLT: dose limiting toxicities; ORR: overall response rate; RCB: residual cancer burden.