NCT05862831 is a Phase 1, PHASE2 clinical trial of PM1003 Injection in Advanced Solid Tumors, sponsored by Biotheus Inc..

Who is sponsoring NCT05862831?

NCT05862831 is sponsored by Biotheus Inc..

What drugs are being tested in NCT05862831?

Interventions in NCT05862831: PM1003 Injection.

What condition does NCT05862831 study?

NCT05862831 studies Advanced Solid Tumors.

Is NCT05862831 still recruiting?

NCT05862831 is currently status unknown. Last updated 17 May 2023.

Last reviewed 2023-05-17 · How we verify

NCT05862831

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

Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors

Status unknown Phase 1, PHASE2 Last updated 17 May 2023

What this trial tests

Phase 1, PHASE2 trial testing PM1003 Injection in Advanced Solid Tumors in 285 participants. Status unknown.

Timeline

7 September 2021

Primary endpoint
7 September 2025

15 November 2025

Quick facts

Lead sponsor	Biotheus Inc.
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	285
Start date	7 September 2021
Primary completion	7 September 2025
Estimated completion	15 November 2025
Sites	2 locations across China

Drugs / interventions tested

PM1003 Injection — full drug profile →

Conditions studied

Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

Biotheus Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single-arm, open-lable, multicenter phase I/IIa clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of PM1003 in the treatment of advanced solid tumors.

Publications & conference data

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

Revolutionizing cancer immunotherapy: unleashing the potential of bispecific antibodies for targeted treatment.
Guo X, Wu Y, Xue Y, Xie N, et al · · 2023 · cited 15× · PMID 38106416 · DOI 10.3389/fimmu.2023.1291836
Anti-PD-L1-Based Bispecific Antibodies Targeting Co-Inhibitory and Co-Stimulatory Molecules for Cancer Immunotherapy.
Geng Q, Jiao P. · · 2024 · cited 14× · PMID 38257366 · DOI 10.3390/molecules29020454
Expanding the horizons of cancer therapy with next-generation 4-1BB agonists: a review of molecular and clinical strategies to maximize efficacy and ensure safety.
You G, Choi J, Yang C, Kim S, et al · · 2026 · cited 1× · PMID 41645963 · DOI 10.1080/19420862.2026.2622746

Verify or expand the search:

Other recruiting trials for Advanced Solid Tumors

Currently open trials in the same condition.

NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. · EARLY_PHASE1 · recruiting
NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other Biotheus Inc. trials

Trials by the same sponsor.

NCT06616532 — PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer · Phase 3 · recruiting
NCT05537051 — A Study of PM1021 (Anti-TIGIT) With or Without PM8001 (Anti-PD-L1/TGF-β) in Patients With Advanced Solid Tumours · Phase 1 · unknown
NCT05879055 — A Study of PM8002 in Combination With Chemotherapy in Patients With NEN · Phase 2 · recruiting
NCT05918107 — A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM · Phase 2 · recruiting
NCT05839106 — Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors · Phase 1, PHASE2 · unknown

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 NCT05862831 (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 Biotheus Inc.
Last refreshed: 17 May 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/NCT05862831.

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