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Table 4 Ongoing clinical trials of BiTE and other CD3-targeting T-cell engager bsAbs in solid tumors

From: The landscape of bispecific T cell engager in cancer treatment

NCT

Phase

Indications

Number of patients

Drug

Target

Results

Reference

NCT01723475

1

Metastatic castration-resistant prostate cancer

47

Pasotuxizumab

CD3/PSMA

In SC group (n = 31),

> 50% PSA decline rate:21%

In cIV group (n = 16),

> 50% PSA decline rate:19%

[77]

NCT03792841

1

Metastatic castration-resistant prostate cancer

43

AMG 160

CD3/PSMA

Any PSA decline rate: 68.6%

> 50% PSA decline rate:34.3%

In patients with evaluable disease (n = 15),

there are 3 PRs and 8 SD

[78]

NCT03296696

1

R/R Glioblastoma

15

AMG 596

CD3/EGFRvIII

In patients with sufficient follow-up (n = 8),

there are 1 PR and 2 SD

[80]

NCT03319940

1

R/R Small-cell lung cancer

40

AMG 757

CD3/DLL3

In patients with evaluable disease (n = 38),

there are 6 confirmed PRs, 11 SD, and 1 unconfirmed PR

[81]

NCT04117958

1

Gastric cancer

–

AMG 199

CD3/MUC 17

Not reported

[82]

NCT04260191

1`

Gastric cancer

–

AMG 910

CD3/CLDN18.2

Not reported

[83]

NCT04128423

1

R/R solid tumors

11

AMV564

CD3/CD33

In patients with evaluable disease (n = 9),

there are 1 PR and 4 SD

[84]

NCT02324257

1

CEA+ advanced solid tumors

80

Cibisatamab

CD3/CEA

In patients with mCRC at doses ≥60 mg (n = 36)

Metabolic PR rate: 28%

[85]

NCT04501770

1

HER2+ advanced solid tumors

–

M802

CD3/HER2

Not reported

[86]

NCT04501744

1

Malignant ascites

–

M701

CD3/EpCAM

Not reported

[87]

NCT02748837

1

Solid malignancies

–

ERY974

CD3/GPC3

Not reported

[88]

NCT02248805

1

R/R Metastatic colorectal carcinoma

95

MGD007

CD3/gpA33

Not reported

[89]

NCT02262910

1

Metastatic castration-resistant prostate cancer

35

ES414

CD3/PSMA

Not reported

[90]

NCT03860207

1

R/R Neuroblastoma, osteosarcoma, and other GD2+ solid tumors

–

Hu3F8-bsAb

CD3/GD2

Not reported

[91]

NCT03983395

1/2

HER2+ metastatic breast cancers

–

ISB 1302

CD3/HER2

Not reported

–

NCT03448042

1

Locally advanced or metastatic HER2+ cancers

–

BTRC4017A

CD3/HER2

Not reported

–

NCT04424641

–

Locally advanced or metastatic solid tumors

–

GEN1044

CD3/5 T4

Not reported

–

  1. R/R Refractory/relapsed, PSMA Prostate-specific membrane antigen, cIV Continuous intravenous, SC Subcutaneous, PSA Prostate-specific antigen, CR Complete remission, PR Partial response, SD Stable disease, EGFRvIII The epidermal growth factor receptor variant III, DLL3 Delta-like 3, MUC 17 Mucin 17, CLDN18.2 Claudin-18 splice variant 2, CEA Carcinoembryonic antigen, Her2 Human epidermal growth factor receptor 2, EpCAM Epithelial cellular adhesion molecule, GPC3 Glypican 3, gpA33 Glycoprotein A33, GD2 Disialoganglioside