NCT07725380 Sirolimus Osteosarcoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07725380 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: 3 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07725380 is a hot trial to watch
Osteosarcoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07725380 is notable because it evaluates Sirolimus in a Phase 1/2 design sponsored by H. Lee Moffitt Cancer Center & Research Institute, Inc.. 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 | NCT07725380 |
| Official title | Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma |
| Phase / status | Phase 1/2 / Recruiting |
| Intervention | Sirolimus |
| Sponsor | H. Lee Moffitt Cancer Center & Research Institute, Inc. |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | Phase 1: Maximum Tolerated Dose (MTD) |
| Endpoint time frame | 28 days |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This is a multicenter, open-label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of domatinostat in combination with sirolimus in adolescents and adults with relapsed or refractory sarcoma and osteosarcoma.
Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Sequential Assignment. Planned enrollment of [object Object] participants across United States 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.
- Phase 1: Maximum Tolerated Dose (MTD) (28 days) — For the phase 1 portion, a standard 3+3 design will be used to determine the MTD and/or RP2D for the Phase 2 portion of this study.
- Phase 2: Arm A Event Free Surival (12 months) — Event free survival (EFS) is defined as the duration of time from start of treatment to time of disease progression, secondary malignancy, or death, whichever occurs first.
- Phase 2: Arm B Event Free Surival (4 months) — Event free survival (EFS) is defined as the duration of time from start of treatment to time of disease progression, secondary malignancy, or death, whichever occurs first.
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: Sirolimus is indexed as Non-degrading molecular glue, with target mTOR, mechanism mTOR inhibitors, and global highest development status Approved.
Company & Deal Intelligence MCP profile: H. Lee Moffitt Cancer Center & Research Institute, Inc. is resolved to a normalized organization record in HILLSBOROUGH COUNTY, United States. 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
NCT07725380 provides a focused lens on Osteosarcoma development. Its value will be determined by whether Sirolimus can convert the current Phase 1/2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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