KD01 in Bladder Cancer: NCT07359235 Clinical Landscape Report 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
Clinical phase
Recruiting
Recruitment status
29
Planned enrollment
2028-12-31
Primary-completion proxy
Executive view
NCT07359235 evaluates KD01 in Bladder Cancer. The disclosed sponsor is Shanghai Tongji Hospital, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is SAEs and AEs（Phase Ia）, assessed over 2 years.
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 NCT07359235 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 KD01, while Company & Deal Intelligence MCP organization_fetch was queried for Shanghai Tongji 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 |
|---|---|---|---|---|---|---|
| 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 |
| CTRI/2026/01/100721 | Gemcitabine Hydrochloride/Docetaxel | Phase 3 / Not Yet Recruiting | Sponsor not reported | India | Timing not reported |
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
NCT07359235 is a Phase 1, 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 “SAEs and AEs（Phase Ia）” over “2 years.” The retrieved endpoint description is: The incidence of serious adverse events (SAEs), the incidence and severity of adverse events (AEs)..
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 NCT07359235 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
KD01 is indexed as Oncolytic virus with target not reported biology and a global stage of Phase 1/2. The asset profile lists Wuhan Kaidejinuo Biotechnology Co., Ltd. as an originator or developer.
Shanghai Tongji Hospital is indexed in China with the website http://english.tjh.com.cn. The organization record is used to resolve sponsor identity. The record lists 11 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 KD01 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: NCT07359235
Protocol source: https://clinicaltrials.gov/study/NCT07359235
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.
KD01 in Bladder Cancer is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes SAEs and AEs（Phase Ia） and 2028-12-31 the leading decision points.
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