NCT07464366 Pucotenlimab Metastatic salivary gland cancer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07464366 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: 27 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07464366 is a hot trial to watch
Metastatic salivary gland cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07464366 is notable because it evaluates Pucotenlimab in a Phase 2 design sponsored by Fudan University. 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 | NCT07464366 |
| Official title | The Safety and Efficacy of MRG003 With or Without Putrelimab in Recurrent or Metastatic Salivary Gland Cancer: a Single-center, Open-label Cohort Study (TSEMPRMSGC) |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Pucotenlimab |
| Sponsor | Fudan University |
| Geography | China |
| Enrollment | 90 |
| Primary endpoint | The objective response rate (ORR) was evaluated by investigators using RECIST 1.1 criteria. |
| Endpoint time frame | From the date of the first dose of Cycle 1 (each cycle is 21 days) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months. |
| Primary completion / readout proxy | 2028-05-30 |
Protocol design and endpoint interpretation
This study is a four-cohort, open-label, single-center Phase II clinical trial aimed at evaluating the efficacy and safety of MRG003 alone or in combination with pertuzumab in patients with recurrent or metastatic adenoid cystic carcinoma (ACC) and other salivary gland cancers (non- ACC SGCs). This study is an exploratory one without a randomized control. After fully informed and signing the informed consent form, eligible subjects will be enrolled in MRG003 treatment [Cohort 1 (ACC) and Cohort 2 (non-ACC SGCs) ] in the order of the study sequence. After the completion of enrollment in Cohort 1, subsequent eligible ACC subjects will be included in the MRG003 plus pertuzumab treatment (Cohort 3), and after the completion of enrollment in Cohort 2, subsequent eligible non-ACC SGC subjects will be included in the MRG003 plus pertuzumab treatment (Cohort 4). Patients in Cohort 1 and Cohort 2 will receive intravenous infusion of MRG003 on th
Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Sequential Assignment. Planned enrollment of 90 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.
- The objective response rate (ORR) was evaluated by investigators using RECIST 1.1 criteria. (From the date of the first dose of Cycle 1 (each cycle is 21 days) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.) — The objective response rate (ORR) is defined as the proportion of subjects in whom the tumor has achieved either complete remission (CR) or partial remission (PR) following treatment.
Readout outlook and evidence gap
The current protocol points to 2028-05-30 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: Pucotenlimab 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: Fudan University is resolved to a normalized organization record in Shanghai Shi, China. 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
NCT07464366 provides a focused lens on Metastatic salivary gland cancer development. Its value will be determined by whether Pucotenlimab can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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