Suncadia's SHR-A2009 trial resumes reporting after status-registry gap
The Phase 1 ADC study raised its enrollment to the actual count of 176 and pushed its completion date three years out as it flips back to active status after a dormant stretch.
Executive Summary
- A Phase 1 antibody-drug conjugate trial that had drifted into an unverified registry status came back online, with its enrollment finalized and its completion timeline reset years forward.
- The update resolves an extended stretch in which the trial's status could not be confirmed, and gives the study a concrete near-term window for the safety and dosing data it is designed to produce.
- This is a dose-escalation and dose-expansion study built to establish tolerability and a recommended Phase 2 dose, not an efficacy comparison, so its news value lies in whether the drug can be dosed safely and reliably at a defined level.
- The asset sits in a modality class already used across two dozen trials in this tumor setting, so the value of this readout will rest on how its tolerability profile compares once dosing is defined, not on breaking new biological ground.
The registry update
The trial, testing SHR-A2009 for injection in patients with advanced tumors, had its status listed as Unknown from January 2025 until July 16, 2026, when the registry recorded three simultaneous changes: status moved to Active, not recruiting; enrollment was finalized at 176 patients, up from an anticipated 132; and the primary completion date moved from December 30, 2023 to December 30, 2026. All three changes landed on the same day, consistent with a sponsor catching up a registry record that had gone stale rather than reworking the study's design. NCT05114759+1A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid TumorsNCT05114759A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid TumorsJul 16, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial tests
The study is a Phase 1, open-label, single-arm trial enrolling patients with ECOG performance status of 0 to 1 who have relapsed or refractory advanced tumors and no standard treatment option. 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, meaning the trial's job is to establish that SHR-A2009 can be dosed safely, not to demonstrate a clinical benefit. Secondary endpoints, including overall response rate, disease control rate, and progression-free survival, are being collected but are not what this stage of the program is designed to prove. NCT05114759A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid TumorsNCT05114759
Enrollment in context
The enrollment increase from 132 to 176, a 33% rise, falls outside what the underlying operational model treats as material for this trial design, since Phase 1 enrollment increases are excluded from its risk thresholds and this program's own baseline verdict on the change is typical. The completion-date reset carries more weight: the registry shows a cumulative primary-completion delay of 1,096 days since the trial's original 2023 target, a pattern consistent with a small, single-arm dose-finding study whose escalation and expansion cohorts took longer to complete than initially projected. NCT05114759A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid TumorsNCT05114759
The competitive setting
SHR-A2009 is an antibody-drug conjugate acting through topoisomerase I inhibition, a modality now used in 21 other trials in advanced tumors, so the mechanism class itself is established rather than novel. The closest mechanism-tier comparator is AbbVie's telisotuzumab adizutecan, an antibody-drug conjugate in Phase 2/3 testing for pancreatic cancer that targets MET rather than SHR-A2009's target, which is not resolved in available records. Suncadia's own completed Phase 1 study of the same drug enrolled 19 patients and finished in April 2024, giving the sponsor one prior human dataset on this molecule before this larger cohort matures. NCT05114759A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid TumorsNCT05114759
Sponsor track record
Suzhou Suncadia Biopharmaceuticals runs a broader pipeline of 96 trials, with 7 completed and 5 terminated among 12 trials with a resolved outcome globally, a completion rate that reflects a sponsor with an established but not uniform execution record across its full portfolio.
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.