Primary Completion Date Change

Suzhou Suncadia pushes SHR-A2009 Phase 1 completion out three years to Dec 2026

The registry now shows a completion date moved from December 2023 to December 2030-12-30... to December 2026, while enrollment reached 176 patients and the trial stayed active through a dormant stretch in between.

By AppliedXLJuly 16, 2026Trial NCT05114759

Executive Summary

A Phase 1 trial testing the antibody-drug conjugate SHR-A2009 in advanced tumors pushed its primary completion date out by three years, resolving a long stretch during which the registry listed the trial as Unknown status.
Enrollment reached its full target under an actual count, and the trial's status reverted to active tracking, which points to a program still running rather than one wound down without disclosure.
The trial's primary endpoints test safety, tolerability, and a recommended Phase 2 dose, not efficacy, so the coming readout will define the drug's dosing path rather than its clinical benefit.
SHR-A2009 sits among a cluster of antibody-drug conjugates advancing in advanced tumors, none of which share its specific molecular target on record, keeping its early read isolated from a head-to-head comparison.

The timing change

Suzhou Suncadia Biopharmaceuticals Co., Ltd. filed a registry update on July 16, 2026 moving the primary completion date for NCT05114759 from December 30, 2023 to December 30, 2026. The same filing lifted enrollment from an anticipated 132 patients to an actual count of 176, and reset the trial's status from Unknown status to Active, not recruiting. The trial had drifted into Unknown status starting January 2, 2025, after running as Recruiting since September 2022, and this update is the first registry confirmation since then that the study is still active. NCT05114759+1

Probability of Success

Endpoint Met24%

Completes88%

Clinical Significance17%

Regulatory48%

What the trial tests

NCT05114759 is a Phase 1, open-label, single-arm study of SHR-A2009 for injection given intravenously to patients with advanced or metastatic tumors who have relapsed on or lack standard treatment, enrolling patients with ECOG performance status 0 to 1. Its primary endpoints are the incidence and severity of adverse events under CTCAE v5.0, the maximum tolerated or administered dose, and the recommended Phase 2 dose, determined from tolerability, pharmacokinetic, and efficacy data collected during dose escalation and expansion. Secondary endpoints track pharmacokinetic parameters, immunogenicity, and RECIST 1.1-based measures including overall response rate, disease control rate, duration of response, and progression-free survival, but none of these have posted results on ClinicalTrials.gov. The trial has not posted results as of this update. NCT05114759

Enrollment and operational context

The trial's 176-patient enrollment now matches its target exactly, with the registry recording the count as actual rather than anticipated. That is consistent with a Phase 1 dose-escalation and expansion design of this scale and does not, on its own, signal distress. Suzhou Suncadia runs SHR-A2009 in one other trial, a completed 19-patient Phase 1 study also in advanced tumors, giving the sponsor a track record of one completed trial for this drug to date. Across its broader pipeline the sponsor has completed 7 of 12 trials with an outcome on record and terminated 5, a mixed but not concentrated pattern that does not bear specifically on this trial's timing. NCT05114759

The competitive field

SHR-A2009 is an antibody-drug conjugate acting through topoisomerase I inhibition, a mechanism class that anchors several late-stage programs in advanced tumors, including AbbVie's telisotuzumab adizutecan and Merck's ifinatamab deruxtecan, both antibody-drug conjugates now in Phase 2 or Phase 3 testing, though against different molecular targets than SHR-A2009's. The trial's own target is not resolved in available records, so no isolation or first-in-class claim follows from that gap; what is clear is that antibody-drug conjugates are a well-populated modality in this indication, with 21 other trials using the same modality in advanced tumors. SHR-A2009's Phase 1 safety and dosing readout will add to that mechanism-class base rather than test an unproven concept. NCT07490301+1

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.