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NCT05848466
Assessment of Safety, Tolerability and Pharmacokinetics With BAT8010 for Injection in Advanced Malignant Solid Tumors Patients
Phase 1 trial testing BAT8010 for Injection in Advanced or Metastatic Solid Tumors in 23 participants. Completed in 6 June 2025.
6 June 2025
Quick facts
| Lead sponsor | Bio-Thera Solutions |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 10 February 2023 |
| Primary completion | 6 June 2025 |
| Estimated completion | 6 June 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- BAT8010 for Injection — full drug profile →
Conditions studied
- Advanced or Metastatic Solid Tumors — all drugs for Advanced or Metastatic Solid Tumors →
Sponsor
Bio-Thera Solutions — full company profile →
Who can join
18 and older, any sex, with Advanced or Metastatic Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this interventional study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BAT8010 for injection in patients with advanced or metastatic solid tumors, explore the maximum tolerable dose. Participants will be given one of below dose once every three weeks: 0.8mg/kg, 1.2mg/kg, 2.4mg/kg, 3.6mg/kg, 4.8mg/kg, 6.0mg/kg, 7.2mg/kg, 8.4mg/kg. The dose escalation follow adopt accelerated titration and "3+3" dose increasing rule.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05848466
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BAT8010 for Injection
Trials testing the same drug.
- NCT06376136 — A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT · Phase 1, PHASE2 · recruiting
Other recruiting trials for Advanced or Metastatic Solid Tumors
Currently open trials in the same condition.
- NCT07510828 — PRISM-NK: Precision-Matched Allogeneic Single- or Dual-Target CAR-NK Cells for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07205718 — A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07260305 — A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolima · Phase 1 · recruiting
- NCT06548217 — A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors · Phase 1 · active not recruiting
- NCT05957081 — Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309 · Phase 1 · 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 NCT05848466 (US National Library of Medicine, public domain)
- 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: 30 March 2026
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/NCT05848466.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing