NCT04638491 is a Phase 1 clinical trial of Lurbinectedin for injection in Advanced Solid Tumor, sponsored by Luye Pharma Group Ltd..

Who is sponsoring NCT04638491?

NCT04638491 is sponsored by Luye Pharma Group Ltd..

What drugs are being tested in NCT04638491?

Interventions in NCT04638491: Lurbinectedin for injection.

What condition does NCT04638491 study?

NCT04638491 studies Advanced Solid Tumor.

Is NCT04638491 still recruiting?

NCT04638491 is currently completed. Last updated 10 June 2024.

Last reviewed 2024-06-10 · How we verify

NCT04638491

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

Safety Tolerability Pharmacokinetic and Preliminary Efficacy in Chinese Advanced Solid Tumors Patients

Completed Phase 1 Last updated 10 June 2024

What this trial tests

Phase 1 trial testing Lurbinectedin for injection in Advanced Solid Tumor in 32 participants. Completed in 4 November 2023.

Timeline

24 November 2020

Primary endpoint
4 November 2023

4 November 2023

Quick facts

Lead sponsor	Luye Pharma Group Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	24 November 2020
Primary completion	4 November 2023
Estimated completion	4 November 2023
Sites	1 location across China

Drugs / interventions tested

Lurbinectedin for injection — full drug profile →

Conditions studied

Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

Luye Pharma Group Ltd. — 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

Phase 1, single-arm, open-label, dose escalating and expansion clinical trial to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of Lurbinectedin (PM01183) for injection in patients with advanced solid tumors

Publications & conference data

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

A pivotal bridging study of lurbinectedin as second-line therapy in Chinese patients with small cell lung cancer.
Cheng Y, Wu C, Wu L, Zhao J, et al · · 2024 · cited 5× · PMID 38351146 · DOI 10.1038/s41598-024-54223-5
Multiple Myeloma: Possible Cure from the Sea.
Capalbo A, Lauritano C. · · 2022 · cited 5× · PMID 35740630 · DOI 10.3390/cancers14122965
Post-marketing safety evaluation of lurbinectedin: a pharmacovigilance analysis based on the FAERS database.
Li Z, Guo C, Liu X, Qiu Z, et al · · 2024 · cited 4× · PMID 38549677 · DOI 10.3389/fphar.2024.1368763

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 Luye Pharma Group Ltd. trials

Trials by the same sponsor.

NCT07516899 — Mass Balance Study of [14C] LPM3770164 in Healthy Participants · Phase 1 · not yet recruiting
NCT07391566 — LPM6690176 in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation · Phase 1, PHASE2 · not yet recruiting
NCT07396870 — A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With Schizophrenia · Phase 2 · not yet recruiting
NCT07371065 — To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Food Effects of LY03021 in Healthy Chinese Sub · Phase 1 · enrolling by invitation
NCT07230652 — A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020 · Phase 1 · 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 NCT04638491 (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 Luye Pharma Group Ltd.
Last refreshed: 10 June 2024

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/NCT04638491.

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