Lutetium-177 DOTA girentuximab in Metastatic Renal Cell Carcinoma: NCT07197580 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: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 3
Clinical phase
Recruiting
Recruitment status
40
Planned enrollment
2027-08-31
Primary-completion proxy
Executive view
NCT07197580 evaluates Lutetium-177 DOTA girentuximab in Metastatic Renal Cell Carcinoma. The disclosed sponsor is Telix Pharmaceuticals Ltd., the design is Interventional, and the geographic footprint is Australia. The first listed primary endpoint is Dose Optimization -safety and tolerability, assessed over Through study completion, an average of 1.5 years.
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 NCT07197580 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Metastatic Renal Cell Carcinoma landscape. Drug & Asset MCP drug_fetch was queried for Lutetium-177 DOTA girentuximab, while Company & Deal Intelligence MCP organization_fetch was queried for Telix Pharmaceuticals Ltd..
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 |
|---|---|---|---|---|---|---|
| NCT07197580 | Lutetium-177 DOTA girentuximab | Phase 3 / Recruiting | Telix Pharmaceuticals Ltd. | Australia | Dose Optimization -safety and tolerability Through study completion, an average of 1.5 years | 2027-08-31 |
| NCT07218692 | RP-2(Replimune Group) | Phase 2 / Not yet recruiting | City of Hope National Medical Center | United States | Objective response rate Up to 2 years | 2027-08-11 |
| NCT07195682 | Ipilimumab | Phase 1 / Recruiting | Bristol Myers Squibb Co. | Canada, United States, Italy, France, Spain | Number of Participants With Adverse Events (AEs) Up to approximately 2 years from first dose of BMS-986506 | 2030-05-03 |
| NCT07187778 | Belzutifan | Phase 2 / Recruiting | The University of Texas MD Anderson Cancer Center | United States | 1. Safety and Adverse Events (AEs) Through study completion; an average of 1 year | 2027-07-19 |
| NCT07187869 | Nivolumab | 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 | 2027-04-07 |
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
NCT07197580 is a Phase 3, recruiting study with 40 planned participants. Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment.
The primary endpoint is “Dose Optimization -safety and tolerability” over “Through study completion, an average of 1.5 years.” The retrieved endpoint description is: Part 1 of the study is being done to identify the best dose to use for Part 2 of the study. Assessing adverse events of special interest (AESIs), incidence and severity of treatment-emergent adverse events (TEAEs) and frequency, severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0, seriousness, and relationship of study treatment will be assessed. Laboratory abnormalities will be assessed according to the NCI CTCAE V5.0..
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 40 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 Renal Cell Carcinoma. These records do not establish direct evidence for NCT07197580 unless the registration number matches.
A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cel…
Phase 3; n=681; Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale(Geometric Mean): Adjusted Geometric Mean Ratio = 2.098(90% CI, 2.001 - 2.200); Adjusted Geometric Mean Ratio = 0.999(90% CI, 0.915 - 1.090); Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale(Geometric Mean) = 75.504 μg/mL (90% Confidence Interval, 70.941 - 80.361) Source: https://clinicaltrials.gov/ct2/show/results/NCT04810078
Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma
Phase 2; n=10; ORR = 0 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT03274258
High Dose IL-2 in Combination With Anti-PD-1 to Overcome Anti-PD-1 Resistance in Metastatic Melanoma and Renal Cell Carcinoma
Phase 2; n=6; ORR = 1 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT03991130
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
Lutetium-177 DOTA girentuximab is indexed as Radiolabeled antibody with CAIX biology and a global stage of Phase 3. The asset profile lists Wilex GmbH Im- u. Export von Investitions- und Verbrauchsgüter as an originator or developer.
Telix Pharmaceuticals Ltd. is indexed in Australia with the website http://www.telixpharma.com. Operates as a commercial-stage biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals The record lists 23 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 Lutetium-177 DOTA girentuximab 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: NCT07197580
Protocol source: https://clinicaltrials.gov/study/NCT07197580
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.
Lutetium-177 DOTA girentuximab in Metastatic Renal Cell Carcinoma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Dose Optimization -safety and tolerability and 2027-08-31 the leading decision points.
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