Table 3 Clinical trials of CD3+ bispecific T-cell redirectors for solid cancers.

From: Overcoming the challenges associated with CD3+ T-cell redirection in cancer

Targets

Clinical trial Phase

Clinical trial identifier

Disease indication(s)

Organisation(s)

Antibody

CD3 × B7-H3

Phase 1

NCT03406949

Advanced solid tumours

MacroGenics

Orlotamab; MGD009

CD3 ×  CEACAM

Phase 1

NCT02291614

NCT01284231

NCT02760199

Gastrointestinal adenocarcinoma

Amgen; MedImmune

AMG 211; MEDI-565

CD3 ×  CEACAM

Phase 1/2

NCT03866239

NCT03337698

NCT02650713

NCT02324257

Colorectal cancer; NSCLC

Hoffmann-La Roche

Cibisatamab; RO6958688

CD3 ×  CLDN18.2

Phase 1

NCT04260191

Gastric and gastro-oesophageal junction adenocarcinoma

Amgen

AMG 910

CD3 × DLL3

Phase 1

NCT03319940

SCLC

Amgen

AMG 757

CD3 ×  EGFRvIII

Phase 1

NCT03296696

Glioblastoma

Amgen

AMG 596

CD3 ×  EGFR

Phase 1/2

NCT01420874

NCT02620865

NCT03269526

NCT03344250

Pancreatic cancer; colorectal cancer; glioblastoma

Barbara Ann Karmanos Cancer Institute; University of Virginia

EGFR2Bi-ATC; EGFR-BATs

CD3 ×  EpCAM

Phase 1

CTR20181212

Malignant ascites

Wuhan YZY Biopharma

M701

CD3 ×  EpCAM

Withdrawn from market

Withdrawn from market

Malignant ascites

Trion Pharma

Catumaxomab; Removab

CD3 × GD2

Phase 1/2

NCT02173093

Neuroblastoma

University of Virginia

GD2Bi-aATC

CD3 ×  gpA33

Phase 1/2

NCT03531632

NCT02248805

Colorectal cancer

MacroGenics

MGD007

CD3 ×  gp100

Phase 1/2

NCT03070392

NCT02535078

NCT02570308

NCT01211262

NCT01209676

Uveal melanoma; malignant melanoma

Immunocore; University of Pennsylvania

IMCgp100

CD3 ×  GPC3

Phase 1

NCT02748837

Solid tumours

Chugai Pharmaceutical

ERY974

CD3 ×  GUCY2c

Phase 1

NCT04171141

Gastrointestinal tumours; colorectal cancer; oesophageal adenocarcinomas

Pfizer

PF-07062119

CD3 ×  HER2

Phase 1/2

NCT03406858

NCT03661424

NCT03272334

NCT00027807

Prostate cancer; breast cancer; leptomeningeal metastases

Barbara Ann Karmanos Cancer Institute; University of Virginia

HER2Bi-ATC; HER2-BATs

CD3 × HER2

Phase 1

NCT03448042

Solid tumours

Genentech

BTRC4017A

CD3 × HER2

Phase 1/2

NCT03983395

Breast cancer

Glenmark Pharmaceuticals

GBR 1302; ISB 1302

CD3 × HER2

Phase 1

CTR20171194

Advanced solid tumours

Wuhan YZY Biopharma

M802

CD3 × MAGE-A4

Phase 1/2

NCT03973333

Advanced solid tumours

Immunocore Ltd

IMC-C103C

CD3 × MSLN × ALB

Phase 1/2

NCT03872206

Ovarian cancer; fallopian tube cancer; peritoneal cancer; pancreatic cancer; mesothelioma

Harpoon Therapeutics

HPN536

CD3 × MUC1

Phase 2

NCT03540199

NCT03524261

NCT03501056

NCT03554395

NCT03509298

NCT03524274

NCT03484962

NCT03146637

Kidney cancer; breast cancer; lung cancer; gastric cancer; pancreatic cancer; colorectal cancer; liver cancer

Fuda Cancer Hospital, Guangzhou; Benhealth Biopharmaceutical

Activated CIK and CD3-MUC1

CD3 × MUC16

Phase 1/2

NCT03564340

Ovarian cancer; fallopian tube cancer; primary peritoneal cancer

Regeneron; Sanofi

REGN4018

CD3 × MUC17

Phase 1

NCT04117958

Gastric and gastro-oesophageal junction cancer

Amgen

AMG 199

CD3 × P-cadherin

Phase 1

NCT02659631

Triple-negative breast cancer; colorectal cancer; NSCLC

Pfizer

PF-06671008

CD3 × PRAME

Phase 1/2

NCT04262466

Advanced solid tumours

Immunocore Ltd

IMC-F106C

CD3 × PSCA

Phase 1

NCT03927573

Pancreatic cancer; breast cancer; urogenital cancer; NSCLC

Celgene

GEM3PSCA

CD3 × PSMA

Phase 1

NCT03926013

Prostate cancer; renal cell carcinoma

Janssen

JNJ-63898081

CD3 × PSMA

Phase 1

NCT03792841

Prostate cancer

Amgen

AMG 160

CD3 × PSMA

Phase 1

NCT01723475

Prostate cancer

Amgen; Bayer

Pasotuxizumab; AMG 212

CD3 × PSMA

Phase 1

NCT02262910

Prostate cancer

Aptevo Therapeutics

ES414

CD3 × PSMA × ALB

Phase 1

NCT03577028

Prostate cancer

Harpoon Therapeutics

HPN424

CD3 × SSTR2

Phase 1

NCT03411915

Neuroendocrine tumours; gastrointestinal stromal tumours

Xencor

Tidutamab; XmAb18087

CD3 × STEAP1

Phase 1

NCT04221542

Prostate cancer

Amgen

AMG 509

CD3 × 5T4

Phase 1/2

NCT04424641

Solid tumours

Genmab; AbbVie

GEN1044

  1. CEACAM carcinoembryonic antigen-related adhesion molecule, CLDN18.2 claudin-18 isoform 2, DLL3 delta-like canonical notch ligand 3, EGFRvIII epidermal growth factor receptor vIII, EGFR epidermal growth factor receptor, EpCAM epithelial cell adhesion molecule, gpA33 glycoprotein A33, gp100 glycoprotein 100, GUCY2c guanylate cyclase 2c, HER2 human epidermal growth factor receptor 2, MAGE-A4 melanoma-associated antigen A4, MSLN mesothelin, ALB albumin, MUC1 mucin 1, MUC16 mucin 16, MUC17 mucin 17, PRAME preferentially expressed antigen in melanoma, PSCA prostate stem cell antigen, PSMA prostate-specific membrane antigen, SSTR2 somatostatin receptor type 2, STEAP1 six transmembrane epithelial antigen of the prostate 1, NSCLC non-small cell lung cancer, SCLC small-cell lung cancer.