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NCT05109650
Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients
Phase 1 trial testing BAT6026 in Advanced Solid Tumour in 13 participants. Terminated before completion.
23 March 2023
Quick facts
| Lead sponsor | Bio-Thera Solutions |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 28 February 2022 |
| Primary completion | 23 March 2023 |
| Estimated completion | 2 February 2024 |
| Sites | 3 locations across Australia |
Drugs / interventions tested
- BAT6026 — full drug profile →
- BAT1308
Conditions studied
- Advanced Solid Tumour — all drugs for Advanced Solid Tumour →
Sponsor
Bio-Thera Solutions — full company profile →
Who can join
18 and older, any sex, with Advanced Solid Tumour. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, open-label, Phase 1 dose-escalation study of BAT6026, an OX40 monoclonal antibody, combined with the anti-PD-1 IgG4 monoclonal antibody BAT1308 in subjects with advanced solid tumours. After a screening period of up to 28 days, qualified subjects will be enrolled to receive their assigned dose regimen until disease progression or intolerable toxicity, withdrawal of consent, per Investigator decision, or end of study, whichever occurs first. The maximum treatment duration is 1 year. Subjects who remain on treatment in the absence of disease progression for more than 1 year may continue to receive study drug for the next cycle at the maximum of 2 years.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
OX40/OX40 ligand and its role in precision immune oncology.
Thapa B, Kato S, Nishizaki D, Miyashita H, et al · · 2024 · cited 45× · PMID 38526805 · DOI 10.1007/s10555-024-10184-9 -
Targeting Co-Stimulatory Receptors of the TNF Superfamily for Cancer Immunotherapy.
Müller D. · · 2023 · cited 24× · PMID 36571696 · DOI 10.1007/s40259-022-00573-3 -
Delivering co-stimulatory tumor necrosis factor receptor agonism for cancer immunotherapy: past, current and future perspectives.
Dadas O, Ertay A, Cragg MS. · · 2023 · cited 18× · PMID 37180119 · DOI 10.3389/fimmu.2023.1147467 -
BAT6026, a novel anti-OX40 antibody with enhanced antibody dependent cellular cytotoxicity effect for cancer immunotherapy.
Liang S, Zheng D, Liu X, Mei X, et al · · 2023 · cited 12× · PMID 37576888 · DOI 10.3389/fonc.2023.1211759 -
Unlocking new frontiers: novel immune targets for next-generation cancer immunotherapy.
Zaheer S, Sureka N. · · 2025 · cited 1× · PMID 40916400 · DOI 10.14216/kjco.24322
Verify or expand the search:
- PubMed search for NCT05109650
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BAT6026
Trials testing the same drug.
- NCT05105971 — Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumor Patients in China · Phase 1 · completed
Other recruiting trials for Advanced Solid Tumour
Currently open trials in the same condition.
- NCT07331155 — A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 03(ESCC)] · Phase 2 · recruiting
- NCT07111546 — A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)] · Phase 2 · recruiting
- NCT06783647 — A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)] · Phase 2 · recruiting
Other Bio-Thera Solutions trials
Trials by the same sponsor.
- NCT07499700 — A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis · Phase 2, PHASE3 · recruiting
- NCT07180862 — A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants · Phase 1 · recruiting
- NCT06545617 — A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer · Phase 1, PHASE2 · withdrawn
- NCT07515079 — Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema · Phase 3 · recruiting
- NCT06280196 — A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants Wit · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05109650 (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 Bio-Thera Solutions
- Last refreshed: 12 August 2025
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/NCT05109650.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing