Entinostat NCT07261592 Clinical Landscape 2026

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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.

Data snapshot: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 1/2

Clinical phase

Not yet recruiting

Recruitment status

29

Planned enrollment

2028-09-30

Primary-completion proxy

Executive view

NCT07261592 evaluates Entinostat in Bladder Cancer. The disclosed sponsor is Nanjing Drum Tower Hospital, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Objective response rate, ORR, assessed over 36 months.

The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.

PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.

How the MCP evidence stack was assembled

Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07261592 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Bladder Cancer landscape. Drug & Asset MCP drug_fetch was queried for Entinostat, while Company & Deal Intelligence MCP organization_fetch was queried for Nanjing Drum Tower Hospital.

This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.

Trial landscape table

Trial	Asset / intervention	Phase / status	Sponsor	Geography	Primary endpoint	Readout proxy
NCT07261592	Entinostat	Phase 1/2 / Not yet recruiting	Nanjing Drum Tower Hospital	China	Objective response rate, ORR 36 months	2028-09-30
NCT07359235	KD01	Phase 1 / Recruiting	Shanghai Tongji Hospital	China	SAEs and AEs（Phase Ia） 2 years	2028-12-31
NCT07346053	Enfortumab Vedotin-ejfv	Phase 3 / Not yet recruiting	British Columbia Cancer Agency	Canada	Objective response rate in in time-of-day administration of EV/P treatment From enrollment to end of follow-up at 24-months.	2030-12-01
NCT07342517	Gemcitabine Hydrochloride/Docetaxel	Phase 3 / Withdrawn	Relmada Therapeutics, Inc.	Geography not reported	To evaluate the efficacy of NDV-01 (determined by complete response [CR] anytime) administered by intravesical instilla… 12 months	2027-06-30
NCT07332351	Gemcitabine Hydrochloride	Phase 2 / Not yet recruiting	University of Washington	United States	Pathological complete response (pCR) on radical cystectomy (RC) specimen At time of radical cystectomy (RC), approximately 4-8 weeks following…	2027-01-01

The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.

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Protocol design and endpoint interpretation

NCT07261592 is a Phase 1/2, not yet recruiting study with 29 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.

The primary endpoint is “Objective response rate, ORR” over “36 months.” The retrieved endpoint description is: 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..

Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 29 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.

No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.

Indexed readouts in the surrounding landscape

5 recent result records were selected as contextual evidence for Bladder Cancer. These records do not establish direct evidence for NCT07261592 unless the registration number matches.

Pilot Study of BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder

Not Applicable; n=4; No numerical result field reported Source: https://clinicaltrials.gov/ct2/show/results/NCT02657486

Artificial intelligence for predicting BCG response in non‐muscle‐invasive bladder cancer: a systematic review

Phase 3; n=24900; BCG-unresponsive disease: P-Value = 0.029; BCG-unresponsive disease: P-Value = 0.029 Source: https://pubmed.ncbi.nlm.nih.gov/42605566/

UGN-102 for Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer: 24-Month Duration of Response Results From the Phase 3 ENVISION Trial

Phase 3; n=240; Adverse Event: dysuria = Treatment-emergent adverse events that occurred in ≥10% of enrolled patients (N = 240) was dysuria Source: https://pubmed.ncbi.nlm.nih.gov/41880645/

Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.

Asset and sponsor context

Entinostat is indexed as Small molecule drug with HDACs biology and a global stage of Approved. The asset profile lists Bayer AG as an originator or developer.

Nanjing Drum Tower Hospital is indexed in China with the website http://www.njglyy.com. Nanjing Drum Tower Hospital specializes in training and diganosis treatment. The record lists 26 development-stage drug assets.

For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.

Development white space

Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
Sequencing white space. Clarify whether Entinostat is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.

White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.

Strategic implications and next readouts

For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.

For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.

Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.

Source trail and bottom line

Anchor trial: NCT07261592
Protocol source: https://clinicaltrials.gov/study/NCT07261592
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 28 September 2026.

Entinostat in Bladder Cancer is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Objective response rate, ORR and 2028-09-30 the leading decision points.

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