Hengrui's SHR-A1811 biliary cancer trial pushes readout to end of 2026
The Phase 2 HER2 antibody-drug conjugate study extended its primary completion date by 16 months as enrollment closed at 59 patients, delaying the ORR readout that will inform Hengrui's broader SHR-A1811 program.
Executive Summary
- A Phase 2 trial testing Hengrui's HER2-directed antibody-drug conjugate in biliary tract cancer pushed its primary completion date out by more than a year, with enrollment now closed at its target size.
- The trial is a single-arm, open-label study measuring objective response rate in patients whose disease progressed after prior chemotherapy, a design that can show whether the drug produces tumor shrinkage but cannot establish a survival benefit on its own.
- HER2-targeted therapy in biliary tract cancer already has a Phase 3 precedent, and this Phase 2 program is one of several antibody-drug conjugates and bispecifics tracking the same target across tumor types, meaning the readout will be judged against an established mechanism rather than a novel one.
- Because SHR-A1811 already runs across ten active trials targeting HER2, this trial's result feeds into a wider read on the molecule's activity beyond its more advanced breast cancer program.
The timing shift
Jiangsu HengRui Medicine Co., Ltd. updated the registry for NCT06413745 on July 17, 2026, moving the trial's primary completion date from September 1, 2025 to December 31, 2026 and its overall completion date to July 31, 2027. The same update dropped the trial's enrollment count from 65 to 59 and flipped its status from Unknown status back to Active, not recruiting, after the record had gone dark since June 1, 2026. Enrollment sits at its revised target of 59 patients, consistent with a study that has finished dosing and moved into follow-up rather than one still recruiting. 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 whose tumors show HER2 expression or amplification and who failed or could not tolerate prior systemic chemotherapy. It runs as a single-arm, open-label design with one experimental arm and no comparator, testing objective response rate assessed by independent review committee under RECIST v1.1 as its primary endpoint, with disease control rate, duration of response, progression-free survival, and overall survival tracked as secondary measures. A single-arm design without a control group can show whether the drug shrinks tumors in this population, but it cannot on its own establish a survival advantage over existing chemotherapy-based options. 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 treatment in biliary tract cancer already has a validated mechanism, with a bispecific antibody from a named competitor running in Phase 3 testing in the same indication, and antibody-drug conjugate competitors from other sponsors advancing through Phase 3 programs in other HER2-positive tumor types. SHR-A1811 itself is being tested in a second, earlier-stage Phase 2 biliary tract cancer trial with a later completion date, run by a separate sponsor. Given a field where a HER2-directed antibody is already in late-stage testing for this indication, a response rate that separates from what chemotherapy alone produces in this refractory population is the result that would make this readout informative beyond the trial itself.
The broader SHR-A1811 program
SHR-A1811 already runs in ten active trials against the HER2 target, spanning breast cancer and other solid tumors, with Hengrui's own Phase 3 breast cancer trial for the same drug further along in development. The sponsor has completed 272 of 300 trials on record, with 28 terminated, giving Hengrui a broad execution history across its pipeline. The delay on this smaller biliary tract cancer cohort sits within a program where the molecule's more advanced testing continues on a separate track, and this readout functions as one additional data point on how far the same antibody-drug conjugate extends beyond its lead indication.
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.