Evidence map›Paper›PMID 40234667›Full record

ArticleBritish journal of cancer2025

First-in-human phase I study of EMB-02, a bispecific antibody targeting PD-1 and LAG-3 in patients with advanced solid tumors.

Daphne Day, Vinod Ganju, Ki Chung, Lu Si, Lili Mao, Morteza Aghmesheh, Robert Hoyer, Kim Brewin, Shuqi Zeng, Mingfei Zhang and 5 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in British journal of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04618393 (A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients With Advanced Solid Tumors), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04618393 phase1 / phase2terminatednot on this map

A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients With Advanced Solid Tumors

TypeinterventionalSponsorShanghai EpimAb Biotherapeutics Co., Ltd.Ran2021 to 2024Enrolled47ConditionsAdvanced Solid TumorsArmsEMB-02
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Daphne DayMedical Oncology Department, Monash Health-Monash MedicalCentre, Clayton, VIC, Australia.ORCID http://orcid.org/0000-0001-8262-2441
Vinod GanjuOncology Department, Peninsula And Southeast Oncology, Frankston, VIC, Australia.
Ki ChungDepartment of Medicine, Prisma Health Cancer Institute, Greenville, SC, USA.
Lu SiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Collaborative Innovation Center for Cancer Medicine, Peking UniversityCancer Hospital and Institute, Beijing, China.
Lili MaoKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Collaborative Innovation Center for Cancer Medicine, Peking UniversityCancer Hospital and Institute, Beijing, China.
Morteza AghmeshehMedical Oncology Department, Prince of Wales Hospital, Sydney, NSW, Australia.
Robert HoyerMedical Oncology Department, UCHealth Memorial Hospital Central, Colorado Springs, CO, USA.
Kim BrewinMedical Oncology Department, Monash Health-Monash MedicalCentre, Clayton, VIC, Australia.
Shuqi ZengClinical Development, Shanghai EpimAb Biotherapeutics Co., Ltd., Shanghai, China.
Mingfei ZhangClinical Development, Shanghai EpimAb Biotherapeutics Co., Ltd., Shanghai, China.
Qiaoyang LuClinical Development, Shanghai EpimAb Biotherapeutics Co., Ltd., Shanghai, China.
Chengjun JiangClinical Development, Shanghai EpimAb Biotherapeutics Co., Ltd., Shanghai, China.
Fang RenClinical Development, Shanghai EpimAb Biotherapeutics Co., Ltd., Shanghai, China.
Yonghong ZhuClinical Development, Shanghai EpimAb Biotherapeutics Co., Ltd., Shanghai, China.
Jun GuoKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Collaborative Innovation Center for Cancer Medicine, Peking UniversityCancer Hospital and Institute, Beijing, China. guoj307@126.com.ORCID http://orcid.org/0000-0003-1759-0986

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEMB-02 is a symmetric bispecific antibody targeting programmed cell death protein-1 and lymphocyte-activation gene 3 simultaneously. Here, we present the first-in-human study results of EMB-02 in patients with advanced solid tumors.

methodsPatients were treated with intravenous infusions of EMB-02 at doses of 6-900 mg. The primary objective was to evaluate the safety and tolerability and to determine the maximum tolerated dose and/or recommended phase II dose(s). Secondary objectives included characterizing the pharmacokinetic (PK) profile, assessing preliminary antitumor activity and the immunogenicity.

resultsA total of 47 patients were enrolled. All grade and grade 3/4 treatment-emergent and treatment related adverse events occurred in 97.9%, 48.9%, 68.1% and 12.8% patients, respectively. The objective response rate (ORR) was 6.4% and clinical benefit rate at 24 weeks (CBR-24) was 25.5% in overall population. The CBR-24 was 33.3% in checkpoint inhibitor (CPI)-naïve patients, and 15% in CPI-treated. No clear relationship was observed between the efficacy and PD-L1, LAG-3, or MHC II expression level. Doses 360 mg or higher resulted in sustained saturation of PD-1 receptors on circulating CD3 + T cells.

conclusionsEMB-02 demonstrated a favorable safety profile and early efficacy signals in multiple solid tumors, warranting further development. (NCT04618393).

Indexed as

Antibodies, BispecificAntigens, CDNeoplasmsProgrammed Cell Death 1 ReceptorAdultAgedAged, 80 and overFemaleHumansLymphocyte Activation Gene 3 ProteinMaleMaximum Tolerated DoseMiddle AgedAntibodies, BispecificAntigens, CDLag3 protein, humanLymphocyte Activation Gene 3 ProteinPDCD1 protein, humanProgrammed Cell Death 1 Receptor

Identifiers

PMID40234667
PMCPMC12081902

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.