NCT04797468 is a Phase 1 clinical trial of HLX23 in Advanced Solid Tumor, sponsored by Shanghai Henlius Biotech.

Who is sponsoring NCT04797468?

NCT04797468 is sponsored by Shanghai Henlius Biotech.

What drugs are being tested in NCT04797468?

Interventions in NCT04797468: HLX23.

What condition does NCT04797468 study?

NCT04797468 studies Advanced Solid Tumor.

Is NCT04797468 still recruiting?

NCT04797468 is currently withdrawn. Last updated 17 January 2023.

Last reviewed 2023-01-17 · How we verify

NCT04797468

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1 Study of the CD73 Inhibitor(HLX23) Alone in Participants With Solid Tumor

Withdrawn Phase 1 Last updated 17 January 2023

What this trial tests

Phase 1 trial testing HLX23 in Advanced Solid Tumor. Withdrawn.

Timeline

18 July 2022

Primary endpoint
13 January 2023

13 January 2023

Quick facts

Lead sponsor	Shanghai Henlius Biotech
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Start date	18 July 2022
Primary completion	13 January 2023
Estimated completion	13 January 2023
Sites	6 locations across United States

Drugs / interventions tested

HLX23 — full drug profile →

Conditions studied

Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

Shanghai Henlius Biotech — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The reason for this study is to see if the CD73 inhibitor HLX23 alone is safe and effective in participants with advanced solid cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

CD39/CD73/A2AR pathway and cancer immunotherapy.
Xia C, Yin S, To KKW, Fu L. · · 2023 · cited 230× · PMID 36859386 · DOI 10.1186/s12943-023-01733-x
Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0
ATP and Adenosine Metabolism in Cancer: Exploitation for Therapeutic Gain.
Yegutkin GG, Boison D. · · 2022 · cited 111× · PMID 35738682 · DOI 10.1124/pharmrev.121.000528
Targeting purinergic pathway to enhance radiotherapy-induced immunogenic cancer cell death.
Bao X, Xie L. · · 2022 · cited 54× · PMID 35836249 · DOI 10.1186/s13046-022-02430-1
The Immune Regulatory Role of Adenosine in the Tumor Microenvironment.
Xing J, Zhang J, Wang J. · · 2023 · cited 34× · PMID 37834375 · DOI 10.3390/ijms241914928
MET-Induced CD73 Restrains STING-Mediated Immunogenicity of EGFR-Mutant Lung Cancer.
Yoshida R, Saigi M, Tani T, Springer BF, et al · · 2022 · cited 33× · PMID 36066413 · DOI 10.1158/0008-5472.can-22-0770
Inhibitors of the CD73-adenosinergic checkpoint as promising combinatory agents for conventional and advanced cancer immunotherapy.
Kurago Z, Guo G, Shi H, Bollag RJ, et al · · 2023 · cited 30× · PMID 37435071 · DOI 10.3389/fimmu.2023.1212209
The inhibitory effect of adenosine on tumor adaptive immunity and intervention strategies.
Wang L, Zhang J, Zhang W, Zheng M, et al · · 2024 · cited 28× · PMID 38799637 · DOI 10.1016/j.apsb.2023.12.004

Verify or expand the search:

Other recruiting trials for Advanced Solid Tumor

Currently open trials in the same condition.

NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting
NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · recruiting

Other Shanghai Henlius Biotech trials

Trials by the same sponsor.

NCT07518043 — A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors · Phase 1 · not yet recruiting
NCT07477587 — A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in · Phase 1 · not yet recruiting
NCT07533708 — A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours · Phase 1 · not yet recruiting
NCT07484893 — A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects · Phase 1 · not yet recruiting
NCT07495930 — Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo® · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04797468 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Henlius Biotech
Last refreshed: 17 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04797468.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing