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NCT07670273 Trastuzumab Rezetecan HER2 positive adenocarcinoma of biliary tract Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

21 July 2026
8 min read

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Turn a newly registered trial into a decision-ready landscape. This focused report examines NCT07670273—Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.

MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.

Why NCT07670273 is a hot trial to watch

HER2 positive adenocarcinoma of biliary tract is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. NCT07670273 is notable because it evaluates Trastuzumab Rezetecan in a Phase 2 design while Using imaging for assessment serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.

PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.

Trial landscape snapshot

FieldIndexed detail
RegistrationNCT07670273
Official titlePhase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer
Phase / statusPhase 2 / Recruiting
InterventionTrastuzumab Rezetecan, Adebrelimab, Lenvatinib mesylate, Lenvatinib
SponsorPeking Union Medical College Hospital
CollaboratorsNot reported
GeographyChina
Enrollment70
Primary endpointUsing imaging for assessment
Endpoint time framethrough study completion, an average of 1 year
Primary completion / readout proxy[object Object]

Design and endpoint interpretation

The phase label is only the starting point. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment of 70 participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

  • Primary: Using imaging for assessment (through study completion, an average of 1 year)
  • Secondary: Overall Survival (OS) was defined as the time from randomization (or treatment initiation) to death from any cause. (through study completion, an average of 1 year)
  • Secondary: DoR was measured from the date of the first documented objective tumor response (per RECIST 1.1 criteria) to the date of the first documented progression or death from any cause. (through study completion, an average of 1 year)
  • Secondary: DCR was assessed per RECIST 1.1 and refers to the proportion of patients whose tumor shrinkage or control met the predefined criteria and was maintained for a minimum specified duration, encompassing CR, PR, and SD. (through study completion, an average of 1 year)
  • Secondary: Progression-Free Survival (PFS) was defined as the time from treatment initiation to the first occurrence of disease progression or death from any cause. (through study completion, an average of 1 year)

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Benchmark readouts in the surrounding field

  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of RDX-002 on Postprandial Triglycerides in Patients Discontinuing the Glucagon-like Peptide-1 (GLP-1) Agonists, Semaglutide, or Tirzepatide for the Treatment of Obesity (Phase 2): Incremental Postprandial Triglycerides (TG)(Mean) = 43.81 percent change (Standard Deviation, 92.373); Incremental Postprandial Triglycerides (TG)(Mean) = -51.91 percent change (Standard Deviation, 72.293)
  • A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Obese But Normal Menstruating Women (Phase 2): Interval From First Dose to Evidence of Ovulation.(Mean) = 2.67 Number of days (Standard Deviation, 1.53); Interval From First Dose to Evidence of Ovulation.(Mean) = 4.0 Number of days (Standard Deviation, 0)
  • A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight (Phase 2): Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -0.4 percent change (Standard Error, 0.91); Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -9.4 percent change (Standard Error, 1.60)

These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.

Build a living trial monitor: connect to PatSnap MCP Servers and track status changes, endpoint revisions, primary-completion dates and newly indexed results without manually reconciling separate databases.

Asset and sponsor context

Drug & Asset context: Trastuzumab Rezetecan (Approved; HER2 x Top I); Adebrelimab (Approved; PDL1); Lenvatinib mesylate (Approved; FGFR1 x FGFR2 x FGFR3 x FGFR4 x PDGFRα x RET x VEGFR1 x VEGFR2 x VEGFR3 x c-Kit)

Company & Deal Intelligence context: Peking Union Medical College Hospital — China — http://www.pumch.cn/index.html

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can decide whether a positive signal becomes a competitive asset.

White space around this program

  • Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
  • Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
  • Sequencing evidence: comparative data after the most relevant contemporary standard of care.
  • Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
  • Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter probability of success before a headline data release.

Bottom line

NCT07670273 is a focused lens on HER2 positive adenocarcinoma of biliary tract development. Its value will be determined by whether Trastuzumab Rezetecan can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.

Ready to reproduce this analysis? Explore PatSnap MCP Servers and combine Clinical Trials, Drug & Asset, and Company & Deal Intelligence as reusable building blocks for trial monitoring and SEO-ready clinical reports.

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