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Table 8 The clinical trials of ADC in TNBC

From: Recent advances in targeted strategies for triple-negative breast cancer

Drug name

Com

Num

Regiments

Phase

Status

Object

POM

NCT number

PTK7-ADC

(PF-06647020)

Gedatolisib

18

PTK7-ADC: 1.4 mg/kg or 2.8 mg/kg on day 1 of every 21 days cycle

Gedatolisb: 110 mg or 180 mg iv on day 1, 8, 15 of every 21 days cycle

I

Completed

TNBC

Safety and toxicity

NCT03243331

Sacituzumab Govitecan (SG, Trodelvy, IMMU-132)

 

80

10 mg/kg iv on day 1 and 8 of a 21-day cycle

II

Active, not recruiting

TNBC

ORR

NCT04454437

SG

 

52

6 mg/kg iv on day 1 and day 8 of a 21-day cycle

I/II

Active, not recruiting

TNBC

TEAEs, DLTs, ORR

NCT05101096

SG

 

540

SG: 10 mg/kg on days 1 and 8 of a 21-day cycle

III

Recruiting

TNBC

PD-L1 negative

PFS

NCT05382299

SG

Trilaciclib (CDK4/6 inhibitor)

30

SG: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline

Trilaciclib: solution as a 30-min iv to be completed within 4 h prior to the start of SG

II

Active, not recruiting

TNBC

PFS

NCT05113966

SG

Talazoparib (PARP inhibitor)

75

SG: 10 mg/kg iv on days 1 and 8 of a 21 day cycle

Talazoparib: qd

I/II

Recruiting

mTNBC

DLTs

NCT04039230

SG

Pembrolizumab

1514

SG: 10 mg/kg iv on days 1 and 8 of 21-day cycles

Pembrolizumab: 200 mg iv on day 1 of 21-day cycles for 8 cycles

III

Recruiting

TNBC

iDFS

NCT05633654

SG

Pembrolizumab

110

SG: given on days 1 and 8 of the 21 days cycle

Pembrolizumab: given on day 1 of the 21 days cycle

II

Recruiting

TNBC

PFS

NCT04468061

SG

Pembrolizumab

260

SG: 10 mg/kg iv, two days per 21-day cycle

Pembrolizumab: 200 mg iv on day 1 of 21-day cycles

II

Recruiting

TNBC

pCR

NCT04230109

SG

Pembrolizumab

440

SG: 10 mg/kg iv on days 1 and 8 of 21-day cycles

Pembrolizumab: 200 mg iv on day 1 of 21-day cycles

III

Recruiting

TNBC

PD-L1 positive

PFS

NCT05382286

TH1902

 

70

300 mg/m2 iv

I

Active, not recruiting

TNBC

Safety and Tolerability

NCT04706962

Datopotamab Deruxtecan (Dato-DXd, DS-1062a)

 

118

NA

multiple cohorts

I/II

Recruiting

TNBC

ORR

NCT05460273

Dato-DXd

 

770

All participants enrolled in the dose escalation part

I

Recruiting

TNBC

DLTs, AEs

NCT03401385

Dato-DXd

 

600

100 mg iv

III

Recruiting

TNBC

PFS

NCT05374512

Dato-DXd

Durvalumab

1075

Dato-DXd: 6 mg/kg iv q3w × 8 cycles

Durvalumab: 1120 mg iv q3w × 9 cycles

III

Recruiting

TNBC

iDFS

NCT05629585

T-DXd

Capecitabine

139

T-DXd: 5.4 mg/kg iv q3w

Capecitabine: 1000 mg/m2 po bid days 1–14 q3w

I

Active, not recruiting

HER2-Low BC

AEs, SAEs

NCT04556773

T-DXd

Durvalumab plus Paclitaxel

139

T-DXd: 5.4 mg/kg iv q3w

Durvalumab: 1120 mg iv q3w

Paclitaxel: 80 mg/m2 iv qw in 3-week cycles

I

Active, not recruiting

HER2-Low BC

AEs, SAEs

NCT04556773

T-DXd

Capivasertib

139

T-DXd: 5.4 mg/kg iv q3w

Capivasertib: 400 mg po bid

I

Active, not recruiting

HER2-Low BC

AEs, SAEs

NCT04556773

T-DXd

Fulvestrant

139

T-DXd: 5.4 mg/kg iv q3w

Fulvestrant: 500 mg im q4w

I

Active, not recruiting

HER2-Low BC

AEs, SAEs

NCT04556773

T-DXd

Anastrozole

88

T-DXd: 5.4 mg/kg iv q3w

Anastrozole: 1 mg/d po

II

Recruiting

HER2-Low BC

pCR

NCT04553770

U3-1402 (Patritumab Deruxtecan)

 

120

5.6 mg/kg iv on day 1 of q3w

II

Recruiting

mBC

ORR, PFS-6

NCT04699630

CAB-ROR2- ADC (BA3021)

PD-1 inhibitor

420

NA

I/II

Recruiting

TNBC

Safety, ORR

NCT03504488

Vobramitamab duocarmazine (MGC018)

 

143

3.0 mg/kg iv q3w

I/II

Active, not recruiting

Advanced Solid Tumor

AEs, SAEs, DLTs

NCT03729596

  1. ADC: antibody–drug conjugate; TNBC: triple negative breast cancer; BC: breast cancer; HER2-: HER2 negative; mBC: metastatic breast cancer; gBRCA1/2 m: germline BRCA1/2 mutated; ORR: overall response rate; PFS: progression-free survival; AEs: adverse events; SAEs: serious adverse events; TEAEs: treatment emergent adverse events; DLTs: dose-limiting toxicity; iDFS: invasive disease-free survival; CDK4/6: cyclin-dependent kinases 4/6; pCR: pathologic complete response