Trial · NCT05249114
Study of Cabozantinib With Lu-177 in Patients With Somatostatin Receptor 2 Positive Neuroendocrine Tumors
NCT05249114, Phase 1, Active not recruiting, Providence Health & Services
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Cabozantinib With Lu-177 in Patients With Somatostatin Receptor 2 Positive Neuroendocrine Tumors. Trials, record NCT05249114. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05249114
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cabozantinib With Lu-177 in Patients With Somatostatin Receptor 2 Positive Neuroendocrine Tumors
- NCT number
- NCT05249114
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- Providence Health & Services
- Conditions
- Neuroendocrine Tumors
- Interventions
- Cabozantinib, Lu-177
- First posted
- 2022-02-21
- Last updated
- 2026-04-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Establish the maximal tolerated dose of cabozantinib in combination with Lu-177 dotatae at a standard dose of 7.4 GBg in four 8-week cycles followed by continuation of cabozantinib. | Up to 2 years | The phase I objective of this study is to establish the maximal tolerated dose (MTD) of cabozantinib in 20 mg, 40 mg and 60 mg dose escalation cohorts in combination with Lu-177 dotatate at a standard dose of 7.4 GBq in four (4) 8-week cycles followed by continuation cabozantinib. Due to overlapping toxicities of cabozantinib and Lu-177 dotatate and to allow more incremental dose escalation of cabozantinib, alternating day dosing of 40mg/20mg and 60mg/40mg cohorts are incorporated into the schema. This is expected to reduce the risk of overlapping toxicities while still achieving radio-sensitizing anti-angiogenic, multi-targeted therapy in combination with the beta-emitting radiation from lutetium 177 synergistic due to the prolonged half-life of cabozantinib. |
| Secondary | Establish objective response rate as measured by RECIST 1.1 | Up to 2 years post study completion | The secondary outcome measure is to establish the objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Imaging is done every 16 weeks and/or re-staging through study completion up to 2 years. A minimum observed overall response rate (ORR) of ≥ 25% in the PRRT-naïve cohort, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in the treatment population would justify further randomized efficacy studies. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05249114
GET https://conductscience.org/api/trials/v1/NCT05249114/registered