Table 6.
Clinical trials of ADCs in lung cancer
| ADC drug name | Target | NCT number | Status (efficacy) | Study phase | Number of subjects | Primary endpoint | Start date |
|---|---|---|---|---|---|---|---|
| T-DM1 | HER2 | NCT04591431 | Not recruiting | II | 384 | ORR | Oct 2020 |
| T-DXd | HER2 | NCT04686305 | Recruiting | Ib | 136 | ORR; PFS; OS | Mar 2021 |
| T-DXd | HER2 | NCT05048797 | Recruiting | III | 246 | PFS | Oct 2021 |
| T-DXd | HER2 | NCT05246514 | Not recruiting | II | 66 | ORR | Jul 2022 |
| T-DXd | HER2 | NCT05650879 | Recruiting | Ia/Ib | 178 | DLT, AEs | Mar 2023 |
| T-DXd | HER2 | NCT05091528 | Terminated | I/II | 2 | DLT, AEs | Feb 2022 |
| T-DXd | HER2 | NCT04644068 | Recruiting | I/II | 559 | AEs | Nov 2020 |
| T-DXd | HER2 | NCT03505710 | Not recruiting | II | 181 | ORR | May 2018 |
| T-DXd | HER2 | NCT04042701 | Recruiting | I | 115 | AEs | Feb 2020 |
| T-DXd | HER2 | NCT05048797 | Recruiting | III | 264 | PFS | Oct 2021 |
| T-DXd | HER2 | NCT04686305 | Recruiting | I | 136 | ORR; PFS; OS | Mar 2021 |
| T-DXd | HER2 | NCT05246514 | Not recruiting | II | 66 | ORR | Jul 2022 |
| T-DXd | HER2 | NCT04644237 | Not recruiting | II | 152 | ORR | Mar 2021 |
| T-DXd | HER2 | NCT03334617 | Recruiting | II | 570 | ORR; PFS; OS | Dec 2017 |
| XMT-1522 | HER2 | NCT02952729 |
Completed (NA) |
I | 120 | Time of maximum concentration | Nov 2016 |
| ADCT-402 | CD19 | NCT04235101 |
Completed (NA) |
I | 120 | ORR | Apr 2023 |
| ADCT-402 | CD19 | NCT02277717 |
Completed (NA) |
I | 185 | AEs | Jan 2019 |
| U3-1402 | HER3 | NCT04619004 | Not recruiting | II | 420 [249] | ORR; PFS; OS | Feb 2021 |
| U3-1402 | HER3 | NCT04676477 | Recruiting | I | 252 [249] | ORR; PFS; OS | Jun 2021 |
| U3-1402 | HER3 | NCT05338970 | Recruiting | III | 560 | PFS | May 2022 |
| SG | Trop-2 | NCT05119907 | Recruiting | II | 300 | DOR; PFS; OS | Oct 2021 |
| DS-1062a | Trop-2 | NCT04484142 | Not recruiting | II | 137 | ORR | Mar 2021 |
| DS-1062a | Trop-2 | NCT04940325 | Recruiting | II | 100 | ORR | May 2021 |
| DS-1062a | Trop-2 | NCT04656652 | Not recruiting | III | 590 | PFS; OS | Dec 2020 |
| DS-1062a | Trop-2 | NCT05460273 | Not recruiting | I/II | 118 | ORR | Jul 2022 |
| DS-1062a | Trop-2 | NCT03401385 | Recruiting | I | 770 | DLT, AEs | Jan 2018 |
| DS-1062a | Trop-2 | NCT05555732 | Recruiting | III | 975 | PFS; OS | Jan 2023 |
| DS-1062a | Trop-2 | NCT04526691 | Not recruiting | I | 140 | DLT, AEs | Sep 2020 |
| DS-1062a | Trop-2 | NCT03944772 | Recruiting | II | 250 | ORR | Jun 2019 |
| DS-1062a | Trop-2 | NCT04612751 | Recruiting | Ib | 232 | DLT, AEs | Feb 2021 |
| IMMU-132 | Trop-2 | NCT05089734 | Not recruiting | III | 580 | OS | Nov 2021 |
| IMMU-132 | Trop-2 | NCT05186974 | Recruiting | II | 224 | DLT | May 2022 |
| IMMU-132 | Trop-2 | NCT04826341 | Recruiting | I/II | 85 | TLT, ORR | Sep 2021 |
| IMMU-132 | Trop-2 | NCT05609968 | Recruiting | III | 614 | PFS; OS | Feb 2023 |
| IMMU-132 | Trop-2 | NCT01631552 |
Completed (Positive) |
I/II | 515 | ORR | Dec 2012 |
| IMMU-132 | Trop-2 | NCT03337698 | Recruiting | Ib/II | 435 | ORR | Jan 2018 |
| IMMU-132 | Trop-2 | NCT05627960 | Recruiting | I | 77 | MTD; MAD; ORR | Feb 2022 |
| Skb-264 | Trop-2 | NCT05631262 | Not yet recruiting | II | 0 | PFS, OS | Nov 2022 |
| Skb-264 | Trop-2 | NCT05870319 | Not yet recruiting | III | 0 | PFS | Jun 2023 |
| Skb-264 | Trop-2 | NCT05816252 | Recruiting | II | 296 | ORR | Apr 2023 |
| Skb-264 | Trop-2 | NCT05351788 | Recruiting | II | 110 | AEs | Apr 2022 |
| Dato-DXd | Trop-2 | NCT05215340 | Recruiting | III | 740 | PFS; OS | Mar 2022 |
| Dato-DXd | Trop-2 | NCT04526691 | Not recruiting | I | 145 | DLT | Sep 2020 |
| ABBV-399 | c-MET | NCT03539536 | Recruiting | II | 275 | ORR; AEs | Oct 2018 |
| ABBV-399 | c-MET | NCT04928846 | Recruiting | III | 698 | PFS | Mar 2022 |
| ABBV-399 | c-MET | NCT03574753 | Completed | II | 28 | ORR | Mar 2018 |
| ABBV-399 | c-MET | NCT05513703 | Recruiting | II | 70 | ORR | Nov 2022 |
| MYTX-011 | c-MET | NCT05652868 | Recruiting | I | 150 | ORR; PFS; OS | Mar 2023 |
| Teliso-V | c-MET | NCT04928846 | Recruiting | III | 698 | PFS; OS | Mar 2022 |
| Rova-T | DLL3 | NCT03061812 |
Completed (Negative) |
III | 444 | ORR; OS | Apr 2017 |
| Rova-T | DLL3 | NCT03033511 | Terminated | III | 748 | PFS; OS | Feb 2017 |
| Rova-T | DLL3 | NCT03334487 | Withdrawn | III | 0 | PFS; OS | Mar 2018 |
| Rova-T | DLL3 | NCT03543358 |
Completed (Negative) |
II | 3 | SAEs | Sep 2018 |
| Rova-T | DLL3 | NCT02674568 |
Completed (Negative) |
II | 342 | ORR; OS | Jan 2016 |
| Rova-T | DLL3 | NCT03026166 | Terminated | I/II | 42 | ORR; PFS; OS | Mar 2017 |
| Rova-T | DLL3 | NCT02709889 | Terminated | I/II | 200 | ORR; PFS; OS | Sep 2016 |
| Rova-T | DLL3 | NCT01901653 |
Completed (Positive) |
I/II | 82 | ORR; DLT | Jul 2013 |
| Rova-T | DLL3 | NCT03086239 |
Completed (NA) |
I | 29 | ORR; PFS; OS | Apr 2017 |
| Rova-T | DLL3 | NCT02874664 |
Completed (NA) |
I | 46 | AEs | Sep 2016 |
| Rova-T | DLL3 | NCT02819999 | Terminated | I | 28 | DLT; TEAEs | Oct 2016 |
| ABBV-181 | DLL3 | NCT03000257 |
Completed (NA) |
I | 182 | MTD | Dec 2016 |
| BA3011 | AXL | NCT04681131 | Recruiting | II | 240 | ORR | Mar 2021 |
| BA3011 | AXL | NCT03425279 | Recruiting | I/II | 120 | ORR | Feb 2018 |
| AXL-107-MMAE | AXL | NCT02988817 |
Completed (Negative) |
I/II | 306 | DLTs | Nov 2016 |
| TIVDAK | TF | NCT03245736 |
Completed (Negative) |
II | 5 | AEs | Aug 2017 |
| TIVDAK | TF | NCT02552121 |
Completed (Negative) |
I/II | 33 | AEs | Nov 2015 |
| TIVDAK | TF | NCT02001623 |
Completed (Positive) |
I/II | 195 | AEs | Nov 2013 |
| TIVDAK | TF | NCT03485209 | Recruiting | II | 532 | ORR | Jun 2018 |
| Tisotumab vedotin | TF | NCT03913741 |
Completed (NA) |
I/II | 23 | AEs | Aug 2020 |
| PF-06647020 | PTK7 | NCT02222922 |
Completed (Positive) |
I | 138 | DLT | Oct 2014 |
| SAR408701 | CEACAM5 | NCT04154956 | Recruiting | III | 450 | PFS; OS | Jan 2017 |
| SAR408701 | CEACAM5 | NCT04394624 | Recruiting | II | 43 | ORR | Aug 2020 |
| SAR408701 | CEACAM5 | NCT04524689 | Recruiting | II | 120 | ORR | Oct 2020 |
| SAR408701 | CEACAM5 | NCT05245071 | Recruiting | II | 38 | ORR | Jun 2022 |
| SAR408701 | CEACAM5 | NCT05703555 | Recruiting | II | 60 | AEs | Feb 2023 |
| SAR408701 | CEACAM5 | NCT02187848 | Not recruiting | III | 263 | AEs | Nov 2020 |
| XMT-1536 | NaPi2b | NCT03319628 | Recruiting | Ib/II | 444 | ORR | Dec 2017 |
| XMT-1536 | NaPi2b | NCT04396340 | Not recruiting | I/II | 120 | DLT | May 2020 |
| MRG003 | EGFR | NCT04838548 | NA | II | 90 | PFS; OS | Sep 2020 |
| ABBV-221 | EGFR | NCT02365662 | Terminated | I | 46 | AEs | Jan 2015 |
| MGC018 | B7-H3 | NCT03729596 | Terminated | I/II | 143 | SAEs | Mar 2023 |
| CX-2009 | CD166 | NCT03149549 | Recruiting | I/II | 99 | ORR | Jun 2017 |
|
Cofetuzumab Pelidotin |
PKT7 | NCT04189614 | Not recruiting | I | 60 | ORR | Feb 2020 |
| SC-002 | SCLC | NCT02500914 | Terminated | I | 35 | MTD | Aug 2018 |
| IMGN901 | CD56 | NCT01237678 | Terminated | I/II | 181 | PFS; MTD | May 2015 |
| IMGN901 | CD56 | NCT00346385 |
Completed (NA) |
I | 97 | AEs | Oct 2011 |
| Glembatumumab vedotin | GPNMB | NCT02713828 | Terminated | I/II | 13 | DOP, PFS, OS | Apr 2016 |
| BAY94-9343 | MSLN | NCT03455556 | Terminated | I | 49 | MTD | Aug 2018 |
| BAY94-9343 | MSLN | NCT02839681 | Terminated | II | 55 | ORR, PFS, OS | Jul 2016 |
| BMS-986148 | MSLN | NCT02341625 | Terminated | I/II | 126 | AEs | Jun 2015 |
| RG7841 | LY6E | NCT02092792 |
Completed (NA) |
I | 42 | DLT | Apr 2014 |
| PF-06263507 | TPBG | NCT01891669 | Terminated | I | 26 | DLT | Aug 2013 |
| BL-B01D1 | EGFR × HER3 | NCT05194982 | Recruiting | I | 96 | DLT, MTD | Nov 2021 |
| BL-B01D1 | EGFR × HER3 | NCT05924841 | Not yet recruiting | II | 100 | PFS, DCR, DOR | Jul 2023 |
| BL-B01D1 | EGFR × HER3 | NCT05880706 | Not yet recruiting | II | 42 | ORR | Jul 2023 |
| BL-B01D1 | EGFR × HER3 | NCT05393427 | Recruiting | I | 26 | DLT, MTD | Feb 2022 |
| BL-B01D1 | EGFR × HER3 | NCT05470348 | Recruiting | I | 36 | DLT, MTD | Aug 2022 |
| BL-B01D1 | EGFR × HER3 | NCT05803018 | Recruiting | I/II | 32 | ORR | Apr 2023 |
| BL-B01D1 | EGFR × HER3 | NCT05785039 | Recruiting | II | 32 | ORR | Apr 2023 |
| SYSA1801 | Claudin 18.2 | NCT05009966 | Recruiting | I | 272 | DLT | Sep 2021 |
| TORL-1–23 | Claudin 6 | NCT05103683 | Recruiting | I | 90 | MTD | Nov 2021 |
| CBP-1008 | TRPV6/FRα | NCT04740398 | Recruiting | I | 143 | AEs, MTD | Mar 2019 |
DLT dose-limiting toxicity, MTD maximum tolerated dose, AE adverse event, Cmax maximum plasma concentration, TEAE treatment-emergent adverse event. NA not available