Table 1.
Ongoing Clinical Trials Evaluating New Antibody–Drug Conjugates in breast cancer in monotherapy
| Target | Antibody drug conjugate | Payload | Linker | DAR | Trial | Population | Phase | Status |
|---|---|---|---|---|---|---|---|---|
| HER2 | Vic-trastuzumab duocarmazine (SYD985) | Duocarmycin (DNA alkylator) | Cleavable | 2.8 | NCT04602117 | HER-positive advanced solid tumors or HER2-low breast cancer | I | Recruiting |
| Disitamab-Vedotin (RC48) | MMAE | Cleavable | 4 | NCT03262935 | Metastatic Breast Cancer | III | Active, not recruiting | |
| NCT05331326 | HER2) expressing breast cancer with abnormal activation of PAM pathway | II | Recruiting | |||||
| NCT04400695 | Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2 | III | Recruiting | |||||
| NCT03052634 | Advanced Breast Cancer With HER2 Positive or HER2 Low Expression | I-II | Active, not Recruiting | |||||
| NCT03500380 | HER2-positive Locally Advanced or Metastatic Breast Cancer | II-III | Recruiting | |||||
| ARX788 | AS269 (tubulin inhibitor) | noncleavable | 1.9 | NCT04829604 | HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd | II | Active, not recruiting | |
| NCT03255070 | Breast Neoplasms | I | Active, not recruiting | |||||
| MRG002 | MMAE | cleavable vc-linker | - | NCT05263869 | HER2-positive Breast Cancer With Liver Metastases | II | Recruiting | |
| NCT04924699 | HER2-positive unresectable locally advanced or metastatic breast cancer | II | Recruiting | |||||
| NCT04742153 | HER2-low locally advanced or metastatic BC | II | Recruiting | |||||
| A166 | Duostatin 5 (Tubulin targeting agent) | Cleavable | 2 | NCT05311397 | unresectable, locally advanced or metastatic HER2-expressing solid tumors | I | Recruiting | |
| NCT03602079 | HER2-positive Breast Cancer | I-II | Active, not recruiting | |||||
| GQ1001 | DM1 (Tubulin targeting agent) |
Intelligent Ligase dependent |
2 | NCT04450732 | HER2-positive Breast Cancer | I | Recruiting | |
| TROP2 | Datopotamab deruxtecan | Deruxtecan | tetrapeptide-based cleavable linker | 8 | NCT03401385 (TROPION-PanTumor01) | Advanced solid tumors | I-II | Recruiting |
| NCT05104866 (TROPION-Breast01) | Inoperable or metastatic HR + /HER2 − breast cancer | III | Recruiting | |||||
| NCT05374512 (TROPION-Breast02) | Locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/ PD-L1 inhibitor therapy | III | Recruiting | |||||
| SKB264 | Belotecan (topoisomerase I inhibitor) | Stable | 7,4 | NCT04152499 | Locally advanced unresectable/metastatic solid tumors (TNBC) | I-II | Recruiting | |
| HER3 | Patritumab deruxtecan | exatecan derivative | Tetrapeptide based | 8 | NCT02980341 | Refractory, advanced/ unresectable mBC | I-II | Active, not recruiting |
| NCT04699630 | Locally advanced BC or mBC | II | Recruiting | |||||
| NCT04965766 | First-line HER3-high, HER2 − ,HR + unresectable locally advanced BC or mBC | II | Recruiting | |||||
| NCT04610528 | HR + / HER2 − tumor with nonmetastatic primary invasive BC untreated and recently diagnosed | I | Recruiting | |||||
| LIV-1 | Ladiratuzumab vedotin | MMAE | cleavable dipeptide linker | 4 | NCT01969643 | Metastatic Breast Cancer | I | Recruiting |
| Nectin-4 | Enfortumab vedotin | MMAE | protease-cleavable | 3.8 | NCT04225117 | Treatment refractory advanced solid tumors (HR + /HER2 − or TNBC) | II | Active, not recruiting |
| CEACAM5 | Tusamitamab ravtansine (SAR408701) | maytansinoid agent DM4 | Cleavable | 3.8 | NCT02187848 | advanced solid tumors | I-II | Active, not recruiting |
| NCT04659603 | Metastatic, refractory, CAECAM-5–expressing breast or pancreatic cancer | II | Recruiting | |||||
| Mesothelin | RC88 | MMAE | cleavable | 4 | NCT04175847 | Locally advanced or metastatic mesothelin-positive solid tumors including TNBC | I | Recruiting |
| cMet | TR1801-ADC | pyrrolobenzodiazepine | cleavable | 2 | NCT03859752 | Solid Tumors Expressing c-Met | I | Active, not recruiting |
| RC108 | MMAE | NCT04617314 | Metastatic refractory solid tumors that express c-Met | I | Recruiting | |||
| 5 T4 | SYD1875 | Duocarmycin (amicrotubuleinhibitor) | cleavable | 1.9 | NCT04202705 | Advanced Malignant Solid Tumors | I | Recruiting |
| ASN004 | Auristatin F hydroxypropylamide | cleavable | 10–12 | NCT04410224 | Metastatic refractory solid tumors | I | Recruiting | |
| FRα | MORAb-202 (farletuzumab ecteribulin) | Eribulin | cleavable | 4 | NCT04300556 | Solid Tumors including TNBC | I-II | Recruiting |
| AMT-151 | - | - | - | NCT05498597 | Advanced Solid Tumor including TNBC | I | Not yet recruiting | |
| PRO1184 | exatecan, a topoisomerase 1 inhibitor | Cleavable | - | NCT05579366 | advanced and/or metastatic solid tumors (TNBC, HR + and HER2 +) | I-II | Recruiting | |
| ROR1 | NBE-002 | Anthracycline-derivative PNU-159682 | Non-cleavable linker | - | NCT04441099 | Locally advanced or metastatic solid malignant tumors (TNBC) | I-II | Recruiting |
| ROR2 | CAB-ROR2-ADC (Ozuriftamab vedotin) | MMAE | cleavable | 3–4 | NCT03504488 | Locally advanced unresectable or metastatic solid tumors (TNBC) | I-II | Recruiting |
| B7-H3 | MGC018 (vobramitamab duocarmazine) | Duocarmazine | cleavable | 2.7 | NCT03729596 | Locally advanced or metastatic solid tumors (TNBC) | I-II | Active, not recruiting |
| B7-H4 | SGN-B7H4V | MMAE | Cleavable | - | NCT05194072 | Advanced Solid Tumors | I-II | |
| AZD8205 | AZ’0133 (topoisomerase 1 inhibitor) | cleavable linker | - | NCT05123482 | Advanced Solid Tumors | I-II | Recruiting | |
| Globo H | OBI-999 | MMAE | Cleavable | - | NTC04084366 | Advanced Solid Tumors with high Globo H–expressing solid tumors (H score ≥ 100) | I | Recruiting |
| KAAG1 | ADCT-901 | pyrrolobenzodiazepine | Cleavable | - | NCT04972981 | Advanced Solid Tumors | I | Recruiting |
| CD205/Ly75 | OBT076 | DM4 | Cleavable | - | NCT04064359 | Recurrent and/or Metastatic CD205 + Solid Tumors | I | Recruiting |