Dragonboat's LDP trial cut enrollment 79% and posted no results at completion
NCT04718584 closed as Completed with enrollment slashed from 127 to 27 and no ClinicalTrials.gov results posted, leaving the pCR and ORR endpoints unresolved.
Executive Summary
- Dragonboat Biopharmaceutical's Phase 2 trial of LDP, a PD-L1 inhibitor, was marked Completed on 2026-07-06 with enrollment cut from 127 to 27, a 79% reduction, and no data posted to ClinicalTrials.gov Press ReleasePress ReleaseJul 6, 2026.
- The trial's primary endpoints, pCR in a bladder cancer surgical cohort and ORR in renal and penile carcinoma cohorts, have gone unreported for more than two years past the 2024-02-27 primary completion date, leaving efficacy entirely unresolved.
- No AppliedXL Probability of Success model read exists for this catalyst; the readout forecast tool returned no prediction row for NCT04718584 [AXL-MODEL].
- The registry's own risk assessment flags this trial as elevated risk, citing a 483-day cumulative completion delay and a 78.7% enrollment shortfall against the original design.
- The enrollment cut and the absence of any posted result on a Completed trial is itself the signal until Dragonboat discloses what the 27 evaluable patients showed.
The registry update
NCT04718584, a Phase 2 study of LDP in muscle-invasive bladder cancer, non-clear cell renal carcinoma, and advanced penile carcinoma, was updated on 2026-07-06 to show a status change to Completed alongside an enrollment revision from 127 to 27 patients Press ReleasePress ReleaseJul 6, 2026. The trial's stated primary completion date is 2024-02-27, meaning the registry update landed more than two years after the date on which the sponsor said its pCR and ORR endpoints would read out. No results have been posted to ClinicalTrials.gov. The trial ran from 2020-09-11 across a single site in China, with Fudan University listed as a collaborator.
What the endpoints measure
The trial carries two primary endpoints split across three cohorts: pathological complete response in Cohort 1, muscle-invasive bladder cancer patients suitable for surgery, measured at the end of treatment cycle 3, and objective response rate by RECIST 1.1 in Cohort 2 (non-clear cell renal cell carcinoma) and Cohort 3 (advanced penile carcinoma). Secondary endpoints include disease control rate, duration of response, overall survival, progression-free survival, and a full safety battery covering adverse events, lab abnormalities, and anti-drug antibody testing. None of these measures has a reported result in the dossier, so whether LDP showed activity in any of the three tumor types remains unknown.
What the enrollment cut signals
The registry's own risk assessment rates this trial 'elevated' risk with a score of 75, driven by three flagged signals: a cumulative primary completion delay of 483 days, an enrollment target decrease of 78.7%, and a final enrollment count 78.7% below the original design. A trial that recruits less than a quarter of its planned population before closing raises the question of whether the sponsor stopped for slow accrual, a deliberate protocol narrowing, or a data-driven decision not disclosed in the registry record Press ReleasePress ReleaseJul 6, 2026. The dossier does not specify which of these applies.
Competitive and field context
LDP is not first-in-class: peer PD-L1 inhibitor programs are broadly active, but none directly compares in this specific combination of bladder, renal, and penile tumor cohorts, so the nearest context is readthrough rather than head-to-head competition Press ReleasePress ReleaseJul 6, 2026. The PD-L1 target overall shows a decelerating field, with recent trial activity at 193 trials versus 1,239 in the older baseline, a ratio of 0.13. Large-scale PD-L1 programs from Roche (atezolizumab), AstraZeneca (durvalumab), and Suzhou Suncadia (adebrelimab, SHR-8068) continue to advance in Phase 3 across other tumor types, underscoring that the mechanism remains active industry-wide even as this specific niche shows limited investment Press ReleasePress ReleaseJul 6, 2026.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.