CTR20262401 Sotiburafusp alfa Endometrial Carcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready landscape. This focused report examines CTR20262401—评估HB0025注射液联合化疗一线治疗晚期/复发pMMR型子宫内膜癌III期临床试验（DUALIGHT-01）—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 CTR20262401 is a hot trial to watch

Endometrial Carcinoma is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. CTR20262401 is notable because it evaluates Sotiburafusp alfa in a Phase 3 design while 主要终点：盲态独立中心阅片（BICR）依据RECIST v1.1标准评估的无进展生存期（PFS）； 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

Design and endpoint interpretation

The phase label is only the starting point. Allocation is 随机化, masking is 双盲, and the intervention model is 平行分组. Planned enrollment of 333 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: 主要终点：盲态独立中心阅片（BICR）依据RECIST v1.1标准评估的无进展生存期（PFS）； (自首次用药开始后的前54周为每9周（±7天）进行影像学检查，之后开始每12周（±7天）进行影像学检查)
• Primary: 关键次要终点：总生存期OS (受试者死亡)
• Secondary: 研究者依据RECIST v1.1标准评估的PFS，客观缓解率（ORR），疾病控制率（DCR），缓解持续时间（DOR），至肿瘤进展时间（TTP）； (自首次用药开始后的前54周为每9周（±7天）进行影像学检查，之后开始每12周（±7天）进行影像学检查)
• Secondary: BICR依据RECIST v1.1标准评估的ORR，DCR，DOR，TTP； (自首次用药开始后的前54周为每9周（±7天）进行影像学检查，之后开始每12周（±7天）进行影像学检查)
• Secondary: 依据NCI-CTCAEv6.0评估的不良事件和严重不良事件的发生率、严重程度及转归、免疫相关不良事件和特别关注的不良事件的发生情况； (试验过程中)

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.

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Asset and sponsor context

Drug & Asset context: Sotiburafusp alfa (Phase 3; PDL1 x VEGF)

Company & Deal Intelligence context: Shanghai Huaaotai Biopharmaceutical Co., Ltd. — China — http://www.huaota.com; Huabo Biopharm Co Ltd. — China — https://www.huabobio.com

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

CTR20262401 is a focused lens on Endometrial Carcinoma development. Its value will be determined by whether Sotiburafusp alfa can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.

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