NCT05879055 is a Phase 2 clinical trial of PM8002 in Neuroendocrine Neoplasm, sponsored by Biotheus Inc..

Who is sponsoring NCT05879055?

NCT05879055 is sponsored by Biotheus Inc..

What drugs are being tested in NCT05879055?

Interventions in NCT05879055: PM8002, FOLFIRI.

What condition does NCT05879055 study?

NCT05879055 studies Neuroendocrine Neoplasm.

Is NCT05879055 still recruiting?

NCT05879055 is currently recruiting now. Last updated 19 December 2024.

Last reviewed 2024-12-19 · How we verify

NCT05879055

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

A Study of PM8002 in Combination With Chemotherapy in Patients With NEN

Recruiting now Phase 2 Last updated 19 December 2024

What this trial tests

Phase 2 trial testing PM8002 in Neuroendocrine Neoplasm in 60 participants. Currently enrolling.

Timeline

17 May 2023

Primary endpoint
1 January 2027

1 January 2028

Quick facts

Lead sponsor	Biotheus Inc.
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	17 May 2023
Primary completion	1 January 2027
Estimated completion	1 January 2028
Sites	13 locations across China

Drugs / interventions tested

PM8002 — full drug profile →
FOLFIRI (folfiri) — full drug profile →

Conditions studied

Neuroendocrine Neoplasm — all drugs for Neuroendocrine Neoplasm →

Sponsor

Biotheus Inc. — full company profile →

Who can join

18 and older, any sex, with Neuroendocrine Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and Ki-67≥55% G3 NET).

Publications & conference data

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

Bispecific Antibodies in Solid Tumors: Advances and Challenges.
Shan KS, Musleh Ud Din S, Dalal S, Gonzalez T, et al · · 2025 · cited 12× · PMID 40565299 · DOI 10.3390/ijms26125838
Gastroenteropancreatic neuroendocrine neoplasms: epidemiology, genetics, and treatment.
Tan B, Zhang B, Chen H. · · 2024 · cited 10× · PMID 39411312 · DOI 10.3389/fendo.2024.1424839

Verify or expand the search:

Other trials of PM8002

Trials testing the same drug.

NCT06837948 — Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC · Phase 2 · not yet recruiting
NCT06616532 — PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer · Phase 3 · recruiting
NCT05918107 — A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM · Phase 2 · recruiting
NCT05918133 — A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC · Phase 1, PHASE2 · active not recruiting
NCT05879068 — A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC · Phase 2 · active not recruiting

Other recruiting trials for Neuroendocrine Neoplasm

Currently open trials in the same condition.

NCT07118176 — Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers · Phase 1 · recruiting
NCT06785597 — EpigenOMic Determinants of the Neuroendocrine Phenotype As Biomarkers for Neuroendocrine Neoplasms · recruiting
NCT06732505 — A Phase I Study to Assess the Safety and Efficacy of [225Ac]Ac-DOTATATE in Patients With SSTR+ GEP-Nens · Phase 1 · recruiting
NCT06855095 — Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial · Phase 2, PHASE3 · recruiting
NCT06276309 — Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors · 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
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
NCT05918133 — A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC · Phase 1, PHASE2 · active not 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 NCT05879055 (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: 19 December 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/NCT05879055.

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