177Lu-FAPI in Glioblastoma: CTRI/2025/11/097005 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 1/2
Clinical phase
Not Yet Recruiting
Recruitment status
20
Planned enrollment
Timing not reported
Primary-completion proxy
Executive view
CTRI/2025/11/097005 evaluates 177Lu-FAPI in Glioblastoma. The disclosed sponsor is Sponsor not reported, the design is Interventional, and the geographic footprint is India. The first listed primary endpoint is not reported, assessed over an unreported time frame.
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 CTRI/2025/11/097005 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Glioblastoma landscape. Drug & Asset MCP drug_fetch was queried for 177Lu-FAPI, 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 |
|---|---|---|---|---|---|---|
| CTRI/2025/11/097005 | 177Lu-FAPI | Phase 1/2 / Not Yet Recruiting | Sponsor not reported | India | Timing not reported | |
| NCT07410676 | Pembrolizumab | Phase 1/2 / Recruiting | Essen BioTech LLC | China | Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) 30 DAYS | 2028-12-21 |
| NCT07392957 | Tovecimig | Phase 1/2 / Recruiting | Washington University School of Medicine | United States | Phase IB Arm 1: Toxicity as measured by number of participants with adverse events Start of treatment through 60 days after treatment (estimated to be 1… | 2029-06-30 |
| NCT07389278 | Temozolomide | Phase 1/2 / Not yet recruiting | The University of California, San Francisco | United States | Proportion of participants with Treatment-emergent Adverse Events (TrAE) (Phase 1) Up to 104 weeks | 2032-06-30 |
| NCT07391215 | Temozolomide | Phase 1/2 / Recruiting | The Institute of Cancer Research: Royal Cancer Hospital | United Kingdom | Phase 1b - Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) in patients with malignant brain tu… 12 months | 2029-01-19 |
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
CTRI/2025/11/097005 is a Phase 1/2, not yet recruiting study with 20 planned participants. Allocation is not reported, masking is not reported, and the intervention model is not reported.
The primary endpoint is “not reported” over “not reported.” The retrieved endpoint description is: To assess FAP expression in-vivo in recurrent glioblastoma multiforme patients using 68Ga-FAPI (46/2286) PET/CT.Timepoint: 0-12 months.
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 20 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. These records do not establish direct evidence for CTRI/2025/11/097005 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
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.libproxy1.nus.edu.sg/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
177Lu-FAPI is indexed as Peptide Conjugate Radionuclide with FAP biology and a global stage of Phase 1. The asset profile lists Pars Isotope Co. as an originator or developer.
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 177Lu-FAPI 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: CTRI/2025/11/097005
Protocol source: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=139021
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.
177Lu-FAPI in Glioblastoma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes the primary endpoint and Timing not reported the leading decision points.
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