Temozolomide in Glioblastoma Multiforme: NCT07635173 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: 16 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Completed
Recruitment status
35
Planned enrollment
2024-04-22
Primary-completion proxy
Executive view
NCT07635173 evaluates Temozolomide in Glioblastoma Multiforme. The disclosed sponsor is Sponsor not reported, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is dose-limiting toxicity (DLT), assessed over From enrollment to the end of treatment at 4 weeks.
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 NCT07635173 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 Temozolomide, while Company & Deal Intelligence MCP organization_fetch was queried for Sponsor not reported.
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 |
|---|---|---|---|---|---|---|
| NCT07635173 | Temozolomide | Phase 1 / Completed | Sponsor not reported | China | dose-limiting toxicity (DLT) From enrollment to the end of treatment at 4 weeks | 2024-04-22 |
| NCT07655869 | Lutetium-177 EBRGD | Early Phase 1 / Recruiting | Beijing Tiantan Hospital | China | Incidence of Dose-Limiting Toxicities (DLTs) Within 6 weeks (42 days) after the first dose (during the first two c… | 2026-12-31 |
| NCT07648823 | [177Lu]Lu-zolbetuximab | Early Phase 1 / Recruiting | Beijing Tiantan Hospital | China | Radiation Dosimetry 30 minutes, 2 hours, 24 hours, 48 hours, 72 hours, and 5-7 days post… | 2027-06-20 |
| NCT07604285 | MT-125 | Phase 1/2 / Not yet recruiting | Myosin Therapeutics, Inc. | United States | Dose Limiting Toxicity Measurement Day 1 through 6 weeks of treatment | 2027-03-01 |
| NCT07579208 | Dual CAR Dual KO NK Cells (The University of Texas MD Anderson Cancer Center) | Phase 1 / Recruiting | The University of Texas MD Anderson Cancer Center | United States | Safety and adverse events (AEs). Through study completion; an average of 1 year | 2028-07-30 |
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
NCT07635173 is a Phase 1, completed study with 35 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “dose-limiting toxicity (DLT)” over “From enrollment to the end of treatment at 4 weeks.” The retrieved endpoint description is: DLT is defined based on the following criteria (referencing NCI CTCAE 5.0 toxicity grading standards): For hematologic toxicity, this includes Grade 4 neutropenia lasting ≥4 days, Grade 3-4 febrile neutropenia, Grade ≥4 thrombocytopenia or anemia, or Grade 3 thrombocytopenia accompanied by clinically significant bleeding or requiring transfusion. For non-hematologic toxicity, this includes Grade ≥3 non-hematologic toxicity (excluding Grade 3 rash, nausea, vomiting, diarrhea, and alopecia that resolve within ≤3 days with optimal supportive care), Grade ≥2 central nervous system toxicity including ataxia and hallu….
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 35 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 NCT07635173 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.libproxy1.nus.edu.sg/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
A First-in-Human Clinical Trial of Pharmacologic Ascorbate and Ferumoxytol Combined With Concomitant Temozolomide and External Beam Radiation Therapy for Newly Diagnosed Glioblast…
Phase 1; n=16; Number of Ferumoxytol-related Dose Limiting Toxicities (DLTs) = 2 Dose Limiting Toxicities ; Number of Ferumoxytol-related Dose Limiting Toxicities (DLTs) = 0 Dose Limiting Toxicities Source: https://clinicaltrials.gov/ct2/show/results/NCT04900792
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
No exact Drug & Asset MCP profile was returned for the protocol wording “Temozolomide.” The report therefore avoids inferring modality, target or global development stage from the name alone.
No exact Company & Deal Intelligence profile was returned for Sponsor not reported. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.
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 Temozolomide 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: NCT07635173
Protocol source: https://clinicaltrials.gov/study/NCT07635173
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: 16 September 2026.
Temozolomide in Glioblastoma Multiforme is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes dose-limiting toxicity (DLT) and 2024-04-22 the leading decision points.
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