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NCT05395260
FL- 101 Study in Non-Metastatic MIBC
EARLY_PHASE1 trial testing FL-101 in Muscle Invasive Bladder Carcinoma. Withdrawn.
28 November 2022
Quick facts
| Lead sponsor | Flame Biosciences |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 22 August 2022 |
| Primary completion | 28 November 2022 |
| Estimated completion | 28 December 2022 |
Drugs / interventions tested
- FL-101 — full drug profile →
Conditions studied
- Muscle Invasive Bladder Carcinoma — all drugs for Muscle Invasive Bladder Carcinoma →
Sponsor
Flame Biosciences — full company profile →
Who can join
18 and older, any sex, with Muscle Invasive Bladder Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A pilot window of opportunity study of FL-101 in patients with non-metastatic MIBC who are eligible for radical cystectomy (RC) but are ineligible for, or decline, cisplatin-based neoadjuvant therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05395260
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of FL-101
Trials testing the same drug.
- NCT04758949 — FL-101 in Surgically Resectable Non-Small Cell Lung Cancer · Phase 2 · withdrawn
Other recruiting trials for Muscle Invasive Bladder Carcinoma
Currently open trials in the same condition.
- NCT06290687 — Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy · Phase 2 · recruiting
- NCT06263153 — Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patie · Phase 2 · recruiting
- NCT05581589 — Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer · Phase 2 · recruiting
- NCT05406713 — Pembrolizumab in Muscle-invasive Bladder Cancer · Phase 2 · active not recruiting
- NCT03775265 — Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer · Phase 3 · active not recruiting
Other Flame Biosciences trials
Trials by the same sponsor.
- NCT04983732 — A Bioavailability Study of FL-101 in Healthy Male and Female Subjects · Phase 1 · completed
- NCT04758949 — FL-101 in Surgically Resectable Non-Small Cell Lung Cancer · Phase 2 · withdrawn
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 NCT05395260 (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 Flame Biosciences
- Last refreshed: 19 August 2022
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/NCT05395260.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing