Trial · NCT06814496
Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors
NCT06814496, Phase 1, Phase 2, Recruiting, University of Arizona
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors. Trials, record NCT06814496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06814496
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors
- NCT number
- NCT06814496
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- University of Arizona
- Conditions
Melanoma, Medullary Thyroid Cancer, Sinonasal Undifferentiated Carcinoma, Esthesioneuroblastoma, Bladder Cancer, Testicular Cancer, Glioblastoma Multiforme, Cervical Cancer, Large Cell Neuroendocrine Carcinoma of the Lung, Non Small Cell Lung Cancer, Merkel Cell Carcinoma
- Interventions
- Tarlatamab, Concurrent Radiation Therapy, Sequential Radiation therapy
- First posted
- 2025-02-07
- Last updated
- 2026-10-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants experiencing dose limiting toxicities (DLT) attributed to radiation or combination of radiation and tarlatamab. | Until radiographic or disease progression or up to 24 months, whichever is earlier. | The primary endpoint is safety, which will be measured by DLT using adverse events graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0) and ASTCT (CRS and ICANS). DLT will be defined as having 1) grade 3 - 5 non-hematologic adverse events (AEs) possibly, probably or definitely related to protocol treatment (radiation or combination of radiation and tarlatamab) by 8 weeks from start of radiation therapy; or 2) AEs possibly, probably, or definitely related to radiation or combination of radiation and tarlatamab leading to early termination of radiation or permanent discontinuation of tarlatamab. Grade 3+ AEs (or discontinuation) due to tarlatamab alone (not attributable to combination therapy) will not contribute to the primary endpoint. Frequency (%) of the patients with DLT will be reported by cohort. |
| Secondary | Objective response rate (ORR) using RESIST/iRECIST and RANO/RANO-BM criteria of radiated and non-radiated sites stratified by anatomic RT site and tumor histology. | Until radiographic or disease progression or up to 24 months, whichever is earlier. | ORR is defined as the percentage of subjects with measurable disease who have at least 1 confirmed response of complete response (CR) or partial response (PR) prior to any evidence of progression. ORR will be reported by cohort and site. |
| Secondary | Toxicity of tarlatamab in tumors in all patients, not of SCLC histology, and stratified by histology in accordance with CTCAE v5. | Until radiographic or disease progression or up to 24 months, whichever is earlier. | Assess toxicity of therapy (tarlatamab with radiation therapy) by the incidence of treatment emergent adverse events reported (to include SAEs and AEs leading to discontinuation) based on CTCAE v5 and ASTCT (CRS and ICANS), stratified by histology and by SCLC vs. tumors that are not SCLC. Counts of all AEs by grade will be provided by cohort. |
| Secondary | Overall survival (OS) | Until radiographic or disease progression or up to 24 months, whichever is earlier. | OS is defined as the time from registration to death and will be estimated using the Kaplan Meier method by cohort. |
| Secondary | Progression free survival (PFS) | Until radiographic or disease progression or up to 24 months, whichever is earlier. | PFS according to RECIST guidelines is defined as the time from registration to progressive disease or death, whichever occurs first, and will be estimated using the Kaplan Meier method by cohort and site if applicable. |
| Secondary | Duration or Response (DOR) | Until radiographic or disease progression or up to 24 months, whichever is earlier. | DOR will only be evaluated in participants with objective response of CR or PR. All confirmed responders will be followed for at least 6 months from the onset of initial response. The end of response will match with the date of progression or death from any cause used for the PFS endpoint. The DOR estimate will be summarized using Kaplan-Meier method by cohort. |
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/NCT06814496
GET https://conductscience.org/api/trials/v1/NCT06814496/registered