NCT07738679 TQB-3454 Locally Advanced Malignant Solid Neoplasm Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07738679 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: 5 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07738679 is a hot trial to watch
Locally Advanced Malignant Solid Neoplasm is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07738679 is notable because it evaluates TQB-3454 in a Phase 2 design sponsored by Chia Tai Tianqing Pharmaceutical Group 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
| Field | Indexed detail |
|---|---|
| Registration | NCT07738679 |
| Official title | Clinical Trial Evaluating the Efficacy and Safety of TQB3454 Tablets in Participants With Advanced Solid Tumors |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | TQB-3454 |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | Disease Control Rate (DCR) |
| Endpoint time frame | up to 48 weeks |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This is a multicenter phase II study designed to evaluate the efficacy and safety of TQB3454 as monotherapy in patients with advanced solid tumors, divided into three cohorts.Cohort 1: Enrolled patients with diffuse glioma harbouring IDH1 R132 mutations. Cohort 2: Enrolled patients with advanced solid tumours (excluding glioma) harbouring IDH1 R132 mutations who failed standard therapy. Cohort 3: Enrolled patients with locally advanced, recurrent and/or metastatic biliary tract cancer without IDH1 mutations who progressed after gemcitabine or fluoropyrimidine-based treatment.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group 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.
- Disease Control Rate (DCR) (up to 48 weeks) — The proportion of participants whose tumors shrank or remained stable for a certain period of time, including cases of CR, PR and SD, was determined by the researchers according to RANO/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: TQB-3454 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: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is resolved to a normalized organization record in Lianyungang, 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
NCT07738679 provides a focused lens on Locally Advanced Malignant Solid Neoplasm development. Its value will be determined by whether TQB-3454 can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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