Hengrui's HER2 ADC SHR-A1811 stays on track in biliary cancer, enrollment trimmed to 59
A registry update shows the Phase 2 trial closed enrollment near its original target and pushed its primary completion date out a year, keeping the ORR readout on the calendar for late 2026.
Executive Summary
- A Phase 2 trial of Jiangsu HengRui Medicine's HER2-directed antibody-drug conjugate SHR-A1811 in biliary tract cancer closed enrollment at its target level and moved to Active, not recruiting, while its primary completion date shifted out more than a year.
- The enrollment count landing at the trial's original target, rather than falling short of it, points to a completed accrual rather than a shortfall, even as the completion timeline moved later.
- The trial's single-arm design means its readout will be judged on response rate against historical expectations for pretreated biliary tract cancer, not against a randomized comparator.
- HER2-positive biliary tract cancer has no other HER2 antibody-drug conjugate in registered testing, though a HER2-directed bispecific antibody from a separate sponsor is already in Phase 3 for the same target-indication pairing, setting a bar the ORR data will need to approach.
The update
Registry records for NCT06413745 show three changes logged on the same day: the trial's status moved from Unknown status to Active, not recruiting, its enrollment count moved from 65 to 59, and its primary completion date moved from September 1, 2025 to December 31, 2026. The trial had briefly lapsed into Unknown status in June 2026 before this update restored a current status and a forward-looking completion date. The 59-patient enrollment figure matches the trial's own registered target, and the trial's enrollment velocity data show it as fully enrolled against that target. NCT06413745Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract CancerNCT06413745
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 enrolls adults with locally advanced unresectable or recurrent metastatic biliary tract cancer who have HER2 expression or amplification and who failed or could not tolerate prior systemic chemotherapy, testing SHR-A1811 as a second-line-or-later treatment in a single, open-label arm of one experimental group. The primary endpoint is objective response rate assessed by independent review committee under RECIST v1.1 criteria, with ten secondary endpoints spanning disease control rate, duration of response, progression-free survival, overall survival, and adverse-event rates. Because the trial carries no comparator arm, the readout will be judged against historical response-rate expectations for this pretreated population rather than a randomized control. NCT06413745Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract CancerNCT06413745
Operational context
The trial has logged a cumulative primary completion delay of 486 days since its original registration, and its registry-churn rate of two changes per year sits in a moderate band. Those shifts track alongside a status lapse to Unknown status in June 2026 that resolved within about six weeks back to Active, not recruiting, once the trial's current enrollment and completion figures were re-submitted. None of these movements changed the trial's endpoints, eligibility criteria, or population, and the enrollment change itself falls within the routine range the operational model uses to flag concerning shifts, landing at 0% deviation from the trial's most recent target. NCT06413745Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract CancerNCT06413745
The competitive field
HER2-directed therapy in biliary tract cancer has one direct precedent already in Phase 3 testing, a HER2-targeted bispecific antibody from a separate sponsor tested in the same target-indication pairing. Hengrui's own SHR-A1811 program is broader than this single trial, with 10 active trials system-wide carrying the drug across HER2-positive cancers, and a second biliary tract cancer trial for the same drug, NCT06778031, is separately recruiting with a target enrollment of 54 and a primary completion date in mid-2028. Beyond biliary tract cancer, HER2-targeted antibody-drug conjugates are each in Phase 3 testing in breast, gastric, or endometrial cancers, reflecting a modality that is established elsewhere in HER2-positive disease but has not yet produced a Phase 3 readout specifically in biliary tract cancer.
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.