NCT05537051

A Study of PM1021 (Anti-TIGIT) With or Without PM8001 (Anti-PD-L1/TGF-β) in Patients With Advanced Solid Tumours

Status unknown Phase 1 Last updated 8 February 2023

What this trial tests

Phase 1 trial testing PM1021, PM8001 in Advanced Solid Tumours in 30 participants. Status unknown.

Timeline

30 October 2023

Primary endpoint
30 October 2024

31 December 2025

Quick facts

Lead sponsor	Biotheus Inc.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	30 October 2023
Primary completion	30 October 2024
Estimated completion	31 December 2025

Drugs / interventions tested

• PM1021, PM8001 — full drug profile →

Conditions studied

• Advanced Solid Tumours — all drugs for Advanced Solid Tumours →

Sponsor

Biotheus Inc. — full company profile →

Who can join

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

Sponsor's own description

The purpose of this research is to assess the safety, tolerability and effectiveness of PM1021 Monotherapy and PM1021 in Combination with PM8001 in Patients with Advanced Solid Tumours. In this study, up to 30 patients will be enrolled in Australia only.

Advanced solid cancers are associated with poor prognosis and pose a significant challenge for treatment strategies. Effective treatments for advanced metastatic malignancies that have failed available standard of care treatment represent a major unmet medical need.

Biotheus Inc. is developing PM1021, a monoclonal anti-T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) antibody (IgG1) and PM8001 (a PD-L1/TGF-beta bispecific Fc fusion protein) as treatment for advanced solid tumours.

Publications & conference data

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

1. Co-inhibition of TIGIT and PD-1/PD-L1 in Cancer Immunotherapy: Mechanisms and Clinical Trials.
   Chu X, Tian W, Wang Z, Zhang J, et al · · 2023 · cited 147× · PMID 37291608 · DOI 10.1186/s12943-023-01800-3
2. Targeting TIGIT for cancer immunotherapy: recent advances and future directions.
   Zhang P, Liu X, Gu Z, Jiang Z, et al · · 2024 · cited 69× · PMID 38229100 · DOI 10.1186/s40364-023-00543-z
3. Macrophage and monocyte subsets as new therapeutic targets in cancer immunotherapy.
   Fendl B, Berghoff AS, Preusser M, Maier B. · · 2023 · cited 34× · PMID 36731326 · DOI 10.1016/j.esmoop.2022.100776
4. Targeting transforming growth factor beta signaling in metastatic osteosarcoma.
   Ge R, Huang GM. · · 2023 · cited 25× · PMID 38021074 · DOI 10.1016/j.jbo.2023.100513
5. Cancer-associated fibroblasts in cancer drug resistance and cancer progression: a review.
   Masuda H. · · 2025 · cited 11× · PMID 40707476 · DOI 10.1038/s41420-025-02566-x
6. The war between the immune system and the tumor - using immune biomarkers as tracers.
   Yang K, Lu R, Mei J, Cao K, et al · · 2024 · cited 9× · PMID 38816871 · DOI 10.1186/s40364-024-00599-5
7. Research progress and future directions of immune checkpoint inhibitor combination therapy in advanced gastric cancer.
   He P, Ma L, Xu B, Wang Y, et al · · 2024 · cited 7× · PMID 39091604 · DOI 10.1177/17588359241266156
8. Emerging Immunotherapy Targets in Early Drug Development.
   Morchón-Araujo D, Catani G, Mirallas O, Pretelli G, et al · · 2025 · cited 6× · PMID 40508202 · DOI 10.3390/ijms26115394