NCT07631871 Zanidatamab HER2 Positive Solid Tumors Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07631871 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 23 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07631871 is a hot trial to watch
HER2 Positive Solid Tumors is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07631871 is notable because it evaluates Zanidatamab in a Phase 2 design sponsored by The Ninth People's Hospital of Shanghai Jiaotong University Medical College. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07631871 |
| Official title | An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Zanidatamab |
| Sponsor | The Ninth People's Hospital of Shanghai Jiaotong University Medical College |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Objective Response Rate, ORR |
| Endpoint time frame | From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24months. |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2 positive advanced solid tumors? Participants will receive Zanidatamab intravenously on Day 1 of each 2-week treatment cycle. The dosage is 20 mg/kg per cycle.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across Not reported in the indexed record 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.
- Objective Response Rate, ORR (From the date of first study treatment until disease progression or death from any cause, whichever occurs first, assessed up to 24months.) — The Objective Response Rate (ORR) is defined as the percentage of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Zanidatamab is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: The Ninth People's Hospital of Shanghai Jiaotong University Medical College did not return an exact normalized organization match in this snapshot. The organization workflow adds identity, location, portfolio and partnering context where available.
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 determine 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.
- Comparator relevance: evidence against the most decision-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 the probability of success before a headline data release.
Bottom line
NCT07631871 provides a focused lens on HER2 Positive Solid Tumors development. Its value will be determined by whether Zanidatamab can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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