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NCT05700084
Tolerability and Bioavailability of Utidelone Capsule in Patients With Advanced Solid Tumors
Phase 1 trial testing Utidelone Capsule (Part 1) in Advanced Solid Tumor in 84 participants. Currently enrolling.
9 March 2025
Quick facts
| Lead sponsor | Beijing Biostar Pharmaceuticals Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 84 |
| Start date | 9 June 2023 |
| Primary completion | 9 March 2025 |
| Estimated completion | 9 April 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Utidelone Capsule (Part 1)
- Drug A Utidelone Capsule (Part 2: Group A-B) — full drug profile →
- Drug A Utidelone Capsule (Part 2: Group B-A) — full drug profile →
- Drug B Utidelone Injection (Part 2: Group A-B)
- Drug B Utidelone Injection (Part 2: Group B-A) — full drug profile →
- Capecitabine (capecitabine) — full drug profile →
- Utidelone Capsule (Part 3)
Conditions studied
- Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
Sponsor
Beijing Biostar Pharmaceuticals Co., Ltd. — full company profile →
Who can join
Adults 18 to 70, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study has three parts. Part 1 is a dose-escalation trial, Part 2 is a pharmacokinetic comparison and food effect study, and Part 3 is extended trial of combination of utidelone capsule and capecitabine. The primary objectives are 1. To evaluate the safety and tolerability of utidelone capsules in patients with advanced solid tumors and to determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT). 2. To evaluate the objective response rate in patients with advanced metastatic breast cancer treated with the combination of utidelone capsule and capecitabine. The secondary objectives are: 1. to evaluate the absolute bioavailability of utidelone capsules relative to utidelone injection; 2. to evaluate the pharmacokinetic profile of utidelone capsules in patients with advanced solid tumors; 3. to preliminarily evaluate the efficacy and safety of utidelone capsules in patients with advanced solid tumors; and 4. to recommend doses and dosing regimens for subsequent clinical trials. 5. To evaluate the Progression-Free Survival (PFS), safety and pharmacokinetics of utidelone capsule combined with capecitabine in the treatment of patients with advanced metastatic breast cancer.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05700084
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Advanced Solid Tumor
Currently open trials in the same condition.
- NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
- NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
- NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
- NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting
- NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · recruiting
Other Beijing Biostar Pharmaceuticals Co., Ltd. trials
Trials by the same sponsor.
- NCT06841679 — Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients Wi · Phase 2, PHASE3 · recruiting
- NCT06730581 — Utidelone Capsule Monotherapy for Patients with Advanced Solid Tumors · Phase 2 · not yet recruiting
- NCT06683703 — Utidelone Injection Combined with Bevacizumab Injection for Non-small Cell Lung Cancer Patients with Brain Metastases · Phase 2 · not yet recruiting
- NCT05673629 — Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With H · Phase 3 · unknown
- NCT05673590 — Utidelone Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer · Phase 3 · unknown
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 NCT05700084 (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 Beijing Biostar Pharmaceuticals Co., Ltd.
- Last refreshed: 19 April 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/NCT05700084.
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