NCT07591090 Ivonescimab Advanced breast 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 NCT07591090 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: 24 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07591090 is a hot trial to watch

Advanced breast cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07591090 is notable because it evaluates Ivonescimab in a Phase 2 design sponsored by Akeso Biopharma Co., Ltd.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 combined with AK112 in advanced breast cancer.

Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Sequential Assignment. Planned enrollment of [object Object] 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.

• Number of participants with dose limiting toxicities (DLTs) (During the first 3 weeks of treatment in Safety Run-in Phase.) — DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug.
• Number of participants with adverse events (AEs) (From the time of signing informed consent form through 30 days(for AEs) or 90 days(for SAEs) after the last dose of study drug.) — AEs refer to any untoward medical occurrence or deterioration of existing medical events after the participants sign the ICFs, whether or not considered related to the study treatment.
• Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 (Up to approximately 2 years.) — ORR is the proportion of participants with complete response(CR) or partial response(PR) , assessed based on RECIST v1.1.

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: Ivonescimab is indexed as Bispecific antibody, with target PD-1 x VEGF-A, mechanism PD-1 inhibitors, VEGF-A inhibitors, and global highest development status Approved.

Company & Deal Intelligence MCP profile: Akeso Biopharma Co., Ltd. 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

NCT07591090 provides a focused lens on Advanced breast cancer development. Its value will be determined by whether Ivonescimab can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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