Table 2.
Summary of the current clinical trials investigating antibody drug conjugates with targets other than HER2. Legend: ° Active, not recruiting; * Not yet recruiting. Abbreviations: ID, identifier; pts, patients; BC, breast cancer; EGFR, epidermal growth factor receptor; mTNBC, metastatic triple negative breast cancer; mBC, metastatic breast cancer; HER2, human epidermal growth factor receptor 2; CT, chemotherapy; ET, endocrine therapy; HR, hormone receptor; TPC, treatment of physician’s choice; eBC, early breast cancer; FRA, folate receptor alpha; HER3, human epidermal growth factor receptor-3; PD-L1, programmed death-ligand 1; 5T4, oncofetal antigen 5T4; ROR2, receptor tyrosine kinase-like orphan receptor 2; TROP-2, Trophoblast cell surface antigen 2; LIV-1, Zinc transporter ZIP6; FRA, Folate receptor alpha; ROR1, receptor tyrosine kinase-like orphan receptor 2; HER3, human epidermal growth factor receptor 3; BRCA1, Breast Related Cancer Antigen 1; BRCA2, Breast Related Cancer Antigen 2; PALB2, Partner and localizer of BRCA2; RAD51C, RAD51 homolog C; RAD51D, RAD51 homolog D; CPS, Combined Positive Score. Source: ClinicalTrial.gov, accessed on 15 March 2021.
| Drug | Target | Trial ID | Study Ph | # of Pts | Patient Cohort | Treatment Arms |
|---|---|---|---|---|---|---|
| ASN004 | 5T4 | NCT04410224 * | I | 43 | Advanced solid tumors (including BC) with literature evidence of 5T4 expression | ASN004 |
| AVID100 | EGFR | NCT03094169 ° | I/II | 90 | Advanced EGFR-overexpressing solid tumors (including TNBC) | AVID100 |
| BA3021 (CAB-ROR2-ADC) |
ROR2 | NCT03504488 | I/II | 120 | Advanced solid tumors (including TNBC) | CAB-ROR2-ADC |
| Datopotamab Deruxtecan (DS-1062) |
TROP-2 |
NCT03401385 (TROPION-PanTumors-01) |
I | 770 | Advanced solid tumors (including TNBC and HR+/HER2-negative BC) | DS-1062 |
|
NCT03742102 (BEGONIA) |
I/II | 200 | First-line treatment in mTNBC | Durvalumb + other agents (DS-1062 in Arm 7) | ||
| Enfortumab Vedotin (ASG-22ME) |
NECTIN-4 |
NCT04225117 (EV-202) |
II | 240 | Advanced solid tumors (including HR+/HER2-negative and TNBC) | Enfortumab Vedotin |
| Ladiratuzumab Vedotin (SGN- LIV1a) |
LIV-1 | NCT01969643 | I | 418 | Pretreated mBC (all subtypes) | SGN- LIV1a +/− Trastuzumab (if HER2-positive) |
| NCT03310957 | I/II | 122 | mTNBC; first-line treatment | SGN-LIV1A + Pembrolizumab | ||
|
NCT03424005 (Morpheus-TNBC) |
I/II | 280 | mTNBC | Umbrella study including a combination of SGN-LIV1A plus Atezolizumab | ||
| MEN1309 (OBT076) |
CD205 | NCT04064359 | I | 70 | CD205-positive HER2-negative advanced solid tumors (including BC) | OBT076 |
| MORAb-202 | FRA | NCT04300556 | I/II | 196 | FRA-positive TNBC, NSCLC, endometrial and ovarian cancer | MORAb-202 |
| NBE-002 | ROR1 | NCT04441099 | I/II | 100 | Advanced solid tumors (including TNBC) | NBE-002 |
| Patritumab Deruxtecan (U3-1402) |
HER3 |
NCT04610528 (TOT-HER3) |
I | 80 | HR+/HER2-negative eBC | U3-1402 |
| NCT02980341 ° | I/II | 180 | HER3-positive mBC: no standard treatment available | U3-1402 | ||
| NCT04699630 * | II | 120 | mBC. For TNBC: at least one but no more than three prior lines of CT. For HR+: no limit to prior ET but no more than two prior CT. | U3-1402 | ||
| Sacituzumab Govitecan (IMMU-132) | TROP-2 | NCT04617522 * | I | 24 | Advanced solid tumor (including BC) in patients with moderate liver impairment | IMMU-132 |
| NCT04039230 | I/II | 75 | mTNBC | IMMU-132 + Talazoparib | ||
|
NCT03424005 (Morpheus-TNBC) |
I/II | 280 | mTNBC | Umbrella study including a combination of IMMU-132 plus atezolizumab | ||
|
NCT03992131 (SEASTAR) |
I/II | 329 | Advanced solid tumor (including TNBC) with a deleterious mutation in BRCA1, BRCA2, PALB2, RAD51C or RAD51D | Rucaparib + IMMU-132 or plus Lucitanib | ||
|
NCT04230109 (NeoSTAR) |
II | 100 | Localized TNBC candidate for neoadjuvant therapy | IMMU-132 +/− Pembrolizumab | ||
| NCT04647916 | II | 44 | HER2-negative BC with brain metastases | IMMU-132 | ||
|
NCT04468061 (Saci-IO TNBC) |
II | 110 | Treatment-naïve mTNBC; PD-L1 negative | IMMU-132 +/− Pembrolizumab | ||
|
NCT04448886 (Saci-IO HR+) |
II | 110 | HR+/HER2-negative mBC; PD-L1 positive (CPS ≥10). Progression on or within 12 months of adjuvant ET or on at least one line of ET for metastatic disease | IMMU-132 +/− Pembrolizumab | ||
| NCT04454437 ° | II | 80 | Chinese patients with mTNBC refractory to at least two lines of CT for mBC | IMMU-132 | ||
|
NCT04595565 (SASCIA) |
III | 1200 | HER2-negative BC with residual disease after neoadjuvant chemotherapy | IMMU-132 vs. TPC | ||
|
NCT03901339 (TROPICS-02) |
III | 400 | HR+/HER2-negative mBC who have failed at least two prior CT regimens | IMMU-132 vs. TPC | ||
| NCT04639986 | III | 330 | HR+/HER2-negative mBC after failure of at least 2, and no more than 4, prior CT for metastatic disease | IMMU-132 vs. TPC |