Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07448922 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.
Bone Cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07448922 is notable because it evaluates Carboplatin in a Phase 2 design sponsored by Sichuan Kelun Botai Biomedicine Co., Ltd.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
| Field | Indexed detail |
|---|---|
| Registration | NCT07448922 |
| Official title | A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Carboplatin |
| Sponsor | Sichuan Kelun Botai Biomedicine Co., Ltd. |
| Geography | China |
| Enrollment | 280 |
| Primary endpoint | Objective Response Rate (ORR) |
| Endpoint time frame | Up to 24 months |
| Primary completion / readout proxy | 2027-12-31 |
This is an open-label, multicenter, Phase II clinical study to evaluate the efficacy and safety of SKB518 as monotherapy or combination therapy in patients with advanced gynecological malignancies. This study will include 5 cohorts: SKB518 as monotherapy in advanced ovarian cancer; SKB518 as monotherapy in advanced cervical cancer and endometrial cancer; SKB518 in combination with Carboplatin in advanced ovarian cancer; SKB518 in combination with Carboplatin and Bevacizumab in advanced ovarian cancer; and SKB518 in combination with Bevacizumab in advanced ovarian cancer. Study hypothesis: SKB518 will show meaningful clinical activity and a favorable risk benefit profile in gynecological malignancies.
Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment of 280 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 current protocol points to 2027-12-31 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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Drug & Asset MCP profile: Carboplatin 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: Sichuan Kelun Botai Biomedicine Co., Ltd. is resolved to a normalized organization record in Chengdu, 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.
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.
NCT07448922 provides a focused lens on Bone Cancer development. Its value will be determined by whether Carboplatin can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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