beta
Trial Radar AI
Clinical Trial NCT07261592 for Bladder Cancer, Histone Deacetylase Inhibitor, Entinostat, Chemotherapy is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer Phase 1, Phase 2 29 Open-Label

Not yet recruiting
Clinical Trial NCT07261592 is designed to study Treatment for Bladder Cancer, Histone Deacetylase Inhibitor, Entinostat, Chemotherapy. This Phase 1 Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 December 2025 until the study accrues 29 participants. Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, this study is expected to complete by 30 April 2029. The latest data from ClinicalTrials.gov was last updated on 3 December 2025.
Brief Summary
This single-center single-arm, open-label prospective clinical trial aimed to evaluate the efficacy and safety of entinostat combined with chemotherapy as second-line therapy for unresectable locally advanced or metastatic bladder cancer.
Official Title

Entinostat Combined With Chemotherapy as Second-line Therapy for Unresectable Locally Advanced or Metastatic Bladder Cancer: A Single-arm, Prospective Clinical Trial

Conditions
Bladder CancerHistone Deacetylase InhibitorEntinostatChemotherapy
Other Study IDs
  • IUNU-UC-108
NCT ID Number
NCT07261592
Start Date (Actual)
2025-12-01
Last Update Posted
2025-12-03
Completion Date (Estimated)
2029-04-30
Enrollment (Estimated)
29
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalEntinostat plus chemotherapy
The study was divided into two phases: chemotherapy phase and continuous treatment phase. During chemotherapy phase, patients receive 6 cycles of GC (gemcitabine and cisplatin) chemotherapy along with entinostat followed by efficacy evaluation. If stable disease is reached according to RECIST 1.1 criteria, patients may receive continuous entinostat treatment until disease progression or intolerable side effects.
Entinostat
Take entinostat 5mg orally once weekly (at least 1 hour before meal and 2 hours after meal).
Chemotherapy
Gisantinib and cisplatin chemotherapy for 6 cycles, 21 days per cycle. Gisantinib 1000mg/m2 is given intravenously on Day 1 and 8 for each cycle while cisplatin 70mg/m2 is given intravenously on Day2.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Objective response rate, ORR
ORR refers to the percentage of confirmed cases of complete response (CR) and partial response (PR) according to the RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1.
36 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
ProgressionFree Survival, PFS
PFS refers to the time from the beginning of treatment to disease progression or death from any reason (whichever occurs first).
36 months
Overall Survival, OS
OS refers to the time from the beginning of treatment to death from any reason.
36 months
Disease Control Rate, DCR
The percentage of cases with CR, PR, and SD (≥4 weeks) among patients with evaluable efficacy.
36 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Histopathologic confirmed unresectable advanced or metastatic bladder cancer, except for those with squamous differentiation, glandular differentiation or both;
  • Failure of first-line treatment;
  • There is at least one measurable lesion according to RECIST 1.1;
  • Archived tumor tissue samples or tumor biopsies must be provided;
  • ECOG score of 0-1 an an estimated survival of at least 6 months;
  • Adequate organ function;
  • Patients voluntarily participated in this study, signed the informed consent form, and had good compliance;
  • Women with fertility must consent to contraception during the study and for 6 months after the last dose of study drug.

  • Patients who received platinum-based chemotherapy after failure of first-line treatment;
  • Patients who received platinum-based chemotherapy withnin a 24 month before this trial;
  • Those who have received other anti-tumor treatment or participated in other clinical studies within 4 weeks before the start of the study, or have not recovered from the last toxicity (except grade 2 hair loss and grade 1 neurotoxicity);
  • Concomitant disease such as uncontrolled hypertension or diabetes, renal inadequacy, myocardial infarction, severe angina;
  • Female subjects who are pregnant, breastfeeding or planning to become pregnant during the study;
  • Patients with serious physical or mental illnesses.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School logoThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Responsible Party
Hongqian Guo, Principal Investigator, Chief physician, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Central Contact
Contact: Junlong Zhuang, PhD, 15950451917, [email protected]
Contact: Hongqian Guo, PhD
1 Study Locations in 1 Countries

Jiangsu

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University, Nanjing, Jiangsu, 210008, China