Evidence map›Paper›PMID 41538111›Full record

ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2026

Phase I Studies of HLX26, A Novel Anti-LAG-3 Antibody, Monotherapy or Combination Therapy in Patients with Advanced Solid Tumors.

Rujiao Liu, Hui Jing, Yang Chen, Shuiping Gao, Jinghao Zhang, Xubo Cao, Ke Li, Yuanyuan Liu, Meng Meng, Cong Chen and 6 more

2 registry-linked trialsAbstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT05078593 phase1completednot on this map

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX26 Monoclonal Antibody Injection (Anti LAG-3 Monoclonal Antibody) in Patients With Advanced/Metastatic Solid Tumor or Lymphoma

TypeinterventionalSponsorShanghai Henlius BiotechRan2021 to 2023Enrolled18ConditionsSolid Tumor, Adult, LymphomaArmsHLX26
NCT05400265 phase1completednot on this map

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 Monoclonal Antibody Injection in Combination With HLX10 Monoclonal Antibody Injection in Patients With Advanced/Metastatic Solid Tumor

TypeinterventionalSponsorShanghai Henlius BiotechRan2022 to 2024Enrolled9ConditionsAdult Solid TumorArmsHLX26, HLX10
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

16 authors.

Rujiao Liu *Phase I Clinical Research Center, Fudan University Cancer Hospital, Shanghai, 200000, China.
Hui Jing *Department of Pulmonary and Critical Care Medicine, Xuzhou Central Hospital, Xuzhou, 210000, China.
Yang ChenPhase I Clinical Research Center, Fudan University Cancer Hospital, Shanghai, 200000, China.
Shuiping GaoPhase I Clinical Research Center, Fudan University Cancer Hospital, Shanghai, 200000, China.
Jinghao ZhangDepartment of Pulmonary and Critical Care Medicine, Xuzhou Central Hospital, Xuzhou, 210000, China.
Xubo CaoDepartment of Pulmonary and Critical Care Medicine, Xuzhou Central Hospital, Xuzhou, 210000, China.
Ke LiDepartment of Pulmonary and Critical Care Medicine, Xuzhou Central Hospital, Xuzhou, 210000, China.
Yuanyuan LiuDepartment of Pulmonary and Critical Care Medicine, Xuzhou Central Hospital, Xuzhou, 210000, China.
Meng MengDepartment of Pulmonary and Critical Care Medicine, Xuzhou Central Hospital, Xuzhou, 210000, China.
Cong ChenShanghai Henlius Biotech, Inc., Shanghai, China.
Ci SunShanghai Henlius Biotech, Inc., Shanghai, China.
Haoyu YuShanghai Henlius Biotech, Inc., Shanghai, China.
Qingyu WangShanghai Henlius Biotech, Inc., Shanghai, China.
Jing LiShanghai Henlius Biotech, Inc., Shanghai, China.
Yanmin WuDepartment of Pulmonary and Critical Care Medicine, Xuzhou Central Hospital, Xuzhou, 210000, China. wymin666@126.com.
Jian ZhangPhase I Clinical Research Center, Fudan University Cancer Hospital, Shanghai, 200000, China. syner2000@163.com.ORCID http://orcid.org/0000-0002-7890-4187

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHLX26 is a novel, recombinant humanized anti-LAG-3 IgG4 monoclonal antibody that exhibits high affinity for LAG-3 and demonstrates that it can block LAG-3 and its ligand interaction and activate T cells in preclinical in vitro studies.

objectiveThese two phase I, dose-escalation studies evaluated the safety, tolerability, pharmacokinetics profile, and preliminary efficacy of HLX26 monotherapy, or in combination with serplulimab (PD-1 inhibitor), in patients with advanced/metastatic solid tumors or lymphomas. PATIENTS AND

methodsAdult patients with advanced/metastatic solid tumors that have failed or deemed clinically unsuitable for standard therapy, or lymphoma received different doses of HLX26 alone (at 60, 150, 300, 500, and 800 mg administered every 3 weeks [Q3W]) in the HLX26-001 study, or HLX26 plus serplulimab (HLX26 at 500, 800, and 1600 mg plus serplulimab (300 mg) administered Q3W) in the HLX26-002 study, respectively. The primary end points for both studies were the dose-limiting toxicities (DLT) and maximum tolerable dose (MTD).

resultsAs of 18 August 2023, with a median follow-up duration of 12.8 months, 26 patients were screened for the HLX26-001 study, 18 of whom were enrolled. As of 31 August 2023, with a median follow up duration of 6.0 months, 14 patients were screened for the HLX26-002 study, 9 of whom received HLX26 plus serplulimab. No DLT was observed, and the MTD was not reached for both studies. In the HLX26-001 study, 17 (94.4%) patients experienced at least one treatment-emergent adverse event (TEAE), most commonly proteinuria (n = 6, 33.3%) and hypercholesterolemia (n = 5, 27.8%). In the HLX26-002 study, all nine (100.0%) patients experienced TEAEs that were all treatment-related and predominantly mild in severity.

conclusionsHLX26 was well-tolerated and safe at various doses as a single agent, and in combination with serplulimab for patients with advanced solid tumors and warrants further investigation.

trial registrationHLX26-001-ClinicalTrials.gov: NCT05078593; HLX26-002-ClinicalTrials.gov: NCT05400265.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsNeoplasmsAdultAgedDose-Response Relationship, DrugFemaleHumansLymphocyte Activation Gene 3 ProteinMaleMaximum Tolerated DoseMiddle AgedAntibodies, Monoclonal, HumanizedLag3 protein, humanLymphocyte Activation Gene 3 Protein

Identifiers

PMID41538111

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.