SONALA-001 in Glioblastoma Multiforme: NCT07076472 Clinical Landscape Report 2026

28 September 2026
9 min read

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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: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Early Phase 1

Clinical phase

Recruiting

Recruitment status

8

Planned enrollment

2028-12-31

Primary-completion proxy

Executive view

NCT07076472 evaluates SONALA-001 in Glioblastoma Multiforme. The disclosed sponsor is Mayo Clinic, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Incidence of adverse events (AEs), assessed over Up to 30 days after last dose of study treatment.

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 NCT07076472 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Glioblastoma Multiforme landscape. Drug & Asset MCP drug_fetch was queried for SONALA-001, while Company & Deal Intelligence MCP organization_fetch was queried for Mayo Clinic.

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

TrialAsset / interventionPhase / statusSponsorGeographyPrimary endpointReadout proxy
NCT07076472SONALA-001Early Phase 1 / RecruitingMayo ClinicUnited StatesIncidence of adverse events (AEs)
Up to 30 days after last dose of study treatment
2028-12-31
NCT07134842IpilimumabPhase 1 / RecruitingUniversity College LondonUnited KingdomIncidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
From trial registration to 3 months post ipilimumab administration
2027-01-01
NCT07100730LomustinePhase 3 / RecruitingTelix Pharmaceuticals Ltd.Netherlands, Austria, Belgium, AustraliaSafety and Tolerability
Through study completion, an average of 2 years
2027-07-01
NCT07093814Recombinant oncolytic virus M1(Guangzhou Vitron)Phase 1/2 / RecruitingGuangzhou Virotech Pharmaceutical Co Ltd.ChinaEvaluate the safety and tolerability of escalating doses of VRT106 in Patients with recurrent/progressive glioblastoma
About 2 years
2028-12-31
NCT07089641ERAS-801Phase 1 / RecruitingJonsson Comprehensive Cancer CenterUnited StatesFludeoxyglucose F-18 (FDG) tumor uptake (Cohort A)
At baseline, prior to initiation of study treatment and after study t…
2027-07-30

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

NCT07076472 is a Early Phase 1, recruiting study with 8 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.

The primary endpoint is “Incidence of adverse events (AEs)” over “Up to 30 days after last dose of study treatment.” The retrieved endpoint description is: Defined per the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 as AEs considered to be at least possibly related to study treatment. The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns (by dose level and overall)..

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 8 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 Glioblastoma Multiforme. These records do not establish direct evidence for NCT07076472 unless the registration number matches.

Phase 1 dose-escalation trial combining sulfasalazine and stereotactic radiosurgery in patients with recurrent glioblastoma

Phase 1; n=12; AE = Of 20 adverse events, two were grade 3 (transient lymphocytopenia), four grade 2, and fourteen grade 1 ; AE = Of 20 adverse events, two were grade 3 (transient lymphocytopenia), four grade 2, and fourteen grade 1 Source: https://pubmed.ncbi.nlm.nih.gov/42229231/

Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide i…

Phase 2; n=624; Median Survival Time (Within Center Group)(Median): Cox Proportional Hazard = 0.95(70% CI, 0.81 - 1.10), P-Value = 0.25; Cox Proportional Hazard = 0.81(70% CI, 0.67 - 0.98), P-Value = 0.11; Median Survival Time (Within Center Group)(Median) = 22.8 months (95% Confidence Interval, 20.0 - 28.6) Source: https://clinicaltrials.gov/ct2/show/results/NCT02179086

Intracranial delivery of B7-H3-targeting CAR-T cells for recurrent glioblastoma: a phase 1 trial

Phase 1; n=15; TRAE(grade 3) = Three grade 3 TRAEs considered serious adverse events occurred (elevated intracranial pressure, epilepsy and depressed consciousness), two at DL3. Source: https://pubmed.ncbi.nlm.nih.gov/42562965/

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

SONALA-001 is indexed as Small molecule drug with target not reported biology and a global stage of Early Phase 1. The asset profile lists SonALAsense, Inc. as an originator or developer.

Mayo Clinic is indexed in United States with the website http://www.mayoclinic.org. MayoClinic is a nonprofit medical practice and medical research group focused on integrated health care, education, and research. The record lists 113 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

  1. 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.
  2. Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
  3. Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
  4. Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
  5. Sequencing white space. Clarify whether SONALA-001 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: NCT07076472
Protocol source: https://clinicaltrials.gov/study/NCT07076472
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: 28 September 2026.

SONALA-001 in Glioblastoma Multiforme is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Incidence of adverse events (AEs) and 2028-12-31 the leading decision points.

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