Metformin Hydrochloride in Metastatic Soft Tissue Sarcoma: NCT07291297 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 2
Clinical phase
Recruiting
Recruitment status
50
Planned enrollment
2028-10-01
Primary-completion proxy
Executive view
NCT07291297 evaluates Metformin Hydrochloride in Metastatic Soft Tissue Sarcoma. The disclosed sponsor is Wake Forest School of Medicine, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Number of participants surviving at 12 months, assessed over From date of metformin start to date of death, or censored at 12 months, whichever occurred first..
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07291297 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Metastatic Soft Tissue Sarcoma landscape. Drug & Asset MCP drug_fetch was queried for Metformin Hydrochloride, while Company & Deal Intelligence MCP organization_fetch was queried for Wake Forest School of Medicine.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07291297 | Metformin Hydrochloride | Phase 2 / Recruiting | Wake Forest School of Medicine | United States | Number of participants surviving at 12 months From date of metformin start to date of death, or censored at 12 mont… | 2028-10-01 |
| NCT07479732 | Apatinib Mesylate | Phase 1/2 / Recruiting | Peking University People's Hospital | China | Recommended Phase II Dose (RP2D) 6 weeks | 2027-03-05 |
| NCT07467122 | TCR-T cells targeting MAGE-A4(Sun Yat-Sen Memorial Hospital) | Phase 1 / Recruiting | Sun Yat-Sen Memorial Hospital | China | Number of participants with treatment-related Grade ≥3 cytokine release syndrome (CRS) or neurotoxicity assessed accord… Within 7 days after TCR-T cell infusion. | 2029-12-31 |
| NCT07460986 | Doxorubicin Hydrochloride | Phase 1/2 / Recruiting | Medica Scientia Innovation Research SL | Spain | Phase Ib: MTD and RP2D Up to 14 months | 2028-07-01 |
| NCT07459283 | 177Lu-INN805 | Early Phase 1 / Recruiting | FindCure Biosciences (ZhongShan) Co., Ltd. | China | Determine dose-limiting toxicity (DLT) 42 days after first dose | 2026-12-01 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07291297 is a Phase 2, recruiting study with 50 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “Number of participants surviving at 12 months” over “From date of metformin start to date of death, or censored at 12 months, whichever occurred first..” The retrieved endpoint description is: 12-month overall survival (OS) will be determined for each participant as a binary variable indicating whether the participant was surviving at 12 months after study enrollment. Failure occurs if the participant dies from any cause within 12 months of study enrollment (initiation of metformin)..
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 50 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Metastatic Soft Tissue Sarcoma. These records do not establish direct evidence for NCT07291297 unless the registration number matches.
Long-term Results of Multiantigen Stimulated Cell Therapy I, Alone or in Combination with Chemotherapy, as First-line Maintenance Therapy in Advanced Sarcoma: A Multicenter, Phase…
Phase 1; n=31; mOS = 33.8 Month Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42545754/
A Phase III Study in Subjects With Relapsing Forms of Multiple Sclerosis (RMS) to Asses Efficacy, Safety and Tolerability of GA Depot, a Long Acting IM Injection of Glatiramer Ace…
Phase 3; n=1016; ARR(Mean) = 0.182 Relapses per participant per year (Standard Error, 0.022); ARR(Mean) = 0.260 Relapses per participant per year (Standard Error, 0.029) Source: https://clinicaltrials.gov/ct2/show/results/NCT04121221
Real-world efficacy of fixed-dose weekly paclitaxel for AIDS-associated Kaposi Sarcoma: a 16-year cohort study in Rio de Janeiro, Brazil
Not Applicable; n=176; CR = 58.0 % Source: https://programme.aids2026.org/Abstract/Abstract/?abstractid=10933
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Metformin Hydrochloride is indexed as Small molecule drug with PRKAB1 biology and a global stage of Approved. The asset profile lists Bristol Myers Squibb Co. as an originator or developer.
Wake Forest School of Medicine is indexed in United States with the website https://school.wakehealth.edu. Wake Forest School of Medicine is an educational institution that specializes in biomedical research. The record lists 15 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Metformin Hydrochloride is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07291297
Protocol source: https://clinicaltrials.gov/study/NCT07291297
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 18 September 2026.
Metformin Hydrochloride in Metastatic Soft Tissue Sarcoma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Number of participants surviving at 12 months and 2028-10-01 the leading decision points.
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