CTR20262356 Precemtabart tocentecan Metastatic Colorectal 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 CTR20262356—在既往经治的转移性结直肠癌试验参与者中比较Precemtabart Tocentecan单药或联合贝伐珠单抗与曲氟尿苷替匹嘧啶联合贝伐珠单抗的III期研究—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 CTR20262356 is a hot trial to watch
Metastatic Colorectal Carcinoma is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. CTR20262356 is notable because it evaluates Precemtabart tocentecan in a Phase 3 design while 第一组，第二组和第三组：总生存期 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
| Field | Indexed detail |
|---|---|
| Registration | CTR20262356 |
| Official title | 在既往经治的转移性结直肠癌试验参与者中比较Precemtabart Tocentecan单药或联合贝伐珠单抗与曲氟尿苷替匹嘧啶联合贝伐珠单抗的III期研究 |
| Phase / status | Phase 3 / 进行中 （尚未招募） |
| Intervention | Precemtabart tocentecan, Bevacizumab, precemtabart tocentecan powder for concentrate for solution for infusion, Bevacizumab Injection, trifluridine/tipiracil |
| Sponsor | BSP Pharmaceuticals SpA, Merck Healthcare KGaA, Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. |
| Collaborators | Not reported |
| Geography | Brazil, United States, Poland, Taiwan Province, Austria, Hong Kong, France, Italy, South Korea, Denmark, Netherlands, Canada, Japan, Germany, China, Spain, Australia, Argentina, United Kingdom, Belgium |
| Enrollment | 123 |
| Primary endpoint | 第一组，第二组和第三组：总生存期 |
| Endpoint time frame | 从随机化日期至死亡的时间，评估平均最长约19个月 |
| Primary completion / readout proxy | 2026-07-07 |
Design and endpoint interpretation
The phase label is only the starting point. Allocation is 随机化, masking is 开放, and the intervention model is 平行分组. Planned enrollment of 123 participants across Brazil, United States, Poland, Taiwan Province, Austria, Hong Kong, France, Italy, South Korea, Denmark, Netherlands, Canada, Japan, Germany, China, Spain, Australia, Argentina, United Kingdom, Belgium 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: 第一组，第二组和第三组：总生存期 (从随机化日期至死亡的时间，评估平均最长约19个月)
- Secondary: 第一组和第二组：总生存期 (从随机化日期至死亡的时间，评估平均最长约19个月)
- Secondary: 无进展生存期（PFS） (从随机化至首次出现疾病进展或死亡（以先发生者为准）的时间（评估平均最长为19个月）。)
- Secondary: 客观缓解率（OR）:研究者根据RECIST v1.1评估。 (平均最长约19个月)
- Secondary: 研究者评估的DoR (从首次记录到客观缓解至疾病进展或死亡的时间。（评估时间为平均最长约 19个月）)
Benchmark readouts in the surrounding field
- The Role of Neutrophil Mitochondrial Dysfunction in Medical Rehabilitation During Palliative Chemotherapy for Metastatic Colorectal Cancer (Phase 2/3): Relative Dose Intensity of FOLFOX(Mean) = 59.7 percentage (Standard Deviation, 18.9); Relative Dose Intensity of FOLFOX(Mean) = 78.4 percentage (Standard Deviation, 15.2)
- AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST-LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E-MUTANT COLORECTAL CANCER (Phase 3): SLI: Number of Participants With Dose Limiting Toxicity (DLTs) = 0 Participants ; SLI: Number of Participants With Dose Limiting Toxicity (DLTs) = 1 Participants
- Liposomal irinotecan combined with 5-FU/LV and bevacizumab as second-line therapy for metastatic colorectal cancer: A multicenter, single-arm phase II study (IRIS). (Phase 2): ORR = 18.0 % ( 11.4 - 26.4)
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: Precemtabart tocentecan (Phase 3; CEACAM5 x Top I); Bevacizumab (Approved; VEGF-A)
Company & Deal Intelligence context: BSP Pharmaceuticals SpA — Italy — http://www.bsppharmaceuticals.com; Merck Healthcare KGaA — Germany — https://www.merckgroup.com/en; Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. — China
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
CTR20262356 is a focused lens on Metastatic Colorectal Carcinoma development. Its value will be determined by whether Precemtabart tocentecan can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.
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