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Table 6 Clinical trials of anti-LAG-3, anti-TIM-3, anti-TIGIT BsAbs

From: Targeting LAG-3, TIM-3, and TIGIT for cancer immunotherapy

Clinical trial identifier

Phase

Start date

Status

Cancer type (population, N)

Interventions and combination

Target

Primary outcome measures

Secondary outcome measures

NCT03219268

I

Aug 18, 2017

Completed

Unresectable or Metastatic Neoplasms, N = 353

Tebotelimab (MGD013)

LAG-3

PD-1

TEAEs, etc

AUC, Cmax, etc

NCT04082364

II/III

Sep 30, 2019

Active, not recruiting

GC, GEJC, HER2 + GC, N = 82

ORR, CR, PR, etc

ADA, etc

NCT04634825

II

Mar 17, 2021

Terminated

HNC, HNSCC, N = 62

ORR, CR, etc

BOR, Cmax, etc

NCT05419388

I/II

Aug 15, 2022

Recruiting

Melanoma, N = 80

RO7247669

LAG-3

PD-1

PFS

ORR, DOR, etc

NCT05645692

II

Apr 13, 2023

Recruiting

UC, N = 240

ORR

OS, DCR, etc

NCT04140500

I/II

Nov 11, 2019

Recruiting

Solid tumor, NSCLC, metastatic melanoma, N = 320

DLTs, ORR, etc

Cmax, AUC, etc

NCT04785820

II

Jun 25, 2021

Recruiting

AMESCC, N = 210

OS

ORR, DCR, etc

NCT05805501

II

Apr 21, 2023

Recruiting

RCC, N = 210

PFS

OS, ORR, etc

NCT05775289

II

Mar 15, 2023

Recruiting

NSCLC, N = 180

PFS, ORR

OS, DOR, etc

NCT04524871

I/II

Nov 2, 2020

Recruiting

Advanced LC, N = 400

ORR

PFS, OS, etc

NCT03440437

I/II

Apr 16, 2018

Recruiting

AMC, HNSCC, N = 80

FS118

LAG-3

PD-L1

AUC, CL, etc

Cmax, Tmax, etc

NCT04618393

I/II

Mar 11, 2021

Recruiting

Advanced solid tumors, N = 43

EMB-02

LAG-3

PD-1

SAEs, ORR, etc

AUC, Cmax, etc

NCT04916119

I

Jun 29, 2021

Recruiting

Advanced malignancies, N = 322

IBI323

LAG-3

PD-L1

AEs, etc

ORR, DCR, etc

NCT03849469

I

May 29, 2019

Completed

Melanoma, CESC, PAAD, TNBC, HCC, BLCA, etc, N = 78

XmAb22841

LAG-3

CTLA-4

AEs

–

NCT05695898

I/II

Feb 28, 2023

Recruiting

AM Melanoma, N = 46

AEs, DLTs, etc

AUC, Cmin, etc

NCT03752177

Ia/Ib

Nov 22, 2018

Terminated

Advanced Solid Tumors, N = 12

LY3415244

TIM-3

PD-L1

DLTs

ORR, DOR, etc

NCT03708328

I

Oct 15, 2018

Active, not recruiting

Advanced and/or metastatic solid tumors, N = 134

Lomvastomig

(R07121661)

TIM-3

PD-1

DLTs, etc

AUC, Cmax, etc

NCT04785820

II

Jun 25, 2021

Recruiting

AMESCC, N = 210

Lomvastomig

(R07121661)

TIM-3

PD-1

OS

ORR, DOR, etc

NCT04931654

I/IIa

Sep 28, 2021

Recruiting

NSCLC, other AST, N = 81

AZD7789

TIM-3

PD-1

AEs, DLTs, etc

OS, etc

NCT05216835

I/II

Mar 18, 2022

Recruiting

R/R HL, N = 180

AZD7789

TIM-3

PD-1

AEs, DLTs, etc

CRR, ORR, etc

NCT05357651

I

Aug 12, 2022

Recruiting

Advanced solid tumors or lymphoma, N = 100

LB1410

TIM-3

PD-1

TEAEs, SAEs, etc

ORR, DCR, etc

NCT05005442

II

Sep 28, 2021

Recruiting

HMs, N = 180

MK-7684A

TIGIT

PD-1

DLTs, AEs

ORR, DOR, etc

NCT04911881

Ia

Jun 24, 2021

Completed

Advanced solid tumors, N = 36

IBI321

TIGIT

PD-1

DLTs, TRAE

ORR, PFS, etc

NCT04911894

I

Jun 21, 2021

Completed

Advanced solid tumors, N = 16

AEs, DLTs

DOR, PFS, etc

NCT04995523

I/II

Sep 14, 2021

Recruiting

NSCLC, N = 192

AZD2936

TIGIT

PD-1

AEs, DLTs, ORR

DCR, DOR, etc

CTR20220021

II

Nov 5, 2021

Recruiting

Advanced solid tumors, N = 30

ZG005

TIGIT

PD-1

DLTs, AEs

DCR, DOR, etc

NCT05025085

I

Oct 4,2021

Active, not recruiting

Advanced cancer, N = 70

AGEN1777

TIGIT

an undisclosed target

DLTs, TEAEs

ADA, CR, etc

  1. ADA antidrug antibody, AEs adverse events, AM advanced and/or metastatic, AMC advanced and/or metastatic cancer, AMESCC advanced and/or metastatic esophageal squamous cell carcinoma, AUC area under the plasma concentration versus time curve, BOR best overall response, BLCA bladder cancer, CESC cervical and endocervical cancers, CL clearance, CR complete response, CRR complete remission rate, DCR disease control rate, DLTs dose-limiting toxicities, DOR duration of response, GC gastric cancer, GEJC gastroesophageal junction cancer, HCC hepatocellular carcinoma, HNC head and neck cancer, HNSCC head and neck squamous cell carcinoma, HMs hematological malignancies, LC liver cancers, Cmax maximum observed serum concentration, Cmin minimum serum concentration, NSCLC non-small cell lung cancer, ORR objective response rate, OS overall survival, PAAD pancreatic adenocarcinoma, PR partial response, PFS progression-free survival, R/R HL relapsed/refractory Hodgkin lymphoma, RCC renal cell carcinoma, SAEs serious adverse events, Tmax time of maximum concentration, n, TEAEs treatment-emergent adverse events, TRAE treatment-related AE, TNBC triple-negative breast cancer, UM unresectable or metastatic, UC urothelial cancer