Study of Ifinatamab Deruxtecan in De Novo or Treatment-Emergent Neuroendocrine Prostate Cancer
NCT07925268, Phase 2, Not yet recruiting, Rahul Aggarwal
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Study of Ifinatamab Deruxtecan in De Novo or Treatment-Emergent Neuroendocrine Prostate Cancer | ClinicalTrials.gov |
| NCT number | NCT07925268 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Rahul Aggarwal | ClinicalTrials.gov |
| Conditions | Neuroendocrine Prostate Cancer (NEPC), Metastatic Prostate Adenocarcinoma, Prostate Cancer | ClinicalTrials.gov |
| Interventions | Ifinatamab Deruxtecan, Positron Emission Tomography (PET)/Computerized Tomography (CT), Computerized Tomography (CT)/ Magnetic Resonance Imaging (MRI), Bone Scan, Blood Specimen Collection | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to 5 years | ORR is defined as the proportion of treated participants who obtained an radiographic objective response \[confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and PCWG4 criteria. Proportion and 95% confidence interval will be reported. | ClinicalTrials.gov |
| Secondary | Median Duration of Response (mDOR) | Up to 5 years | mDOR is defined as the time that elapses between the day of first documented response to trial therapy (confirmed CR or confirmed PR, whichever is first recorded) and date of the first radiographic progression(per RECIST v1.1 criteria). Results will be calculated based on Kaplan-Meier product limit method. | ClinicalTrials.gov |
| Secondary | Median radiographic Progression-free survival (rPFS) | Up to month 12 | Radiographic progression-free survival (rPFS) is defined as the time from the date of first study treatment to the first documented radiographic disease progression, as defined by RECIST 1.1 and PCWG4 criteria, or death from any cause, whichever occurs first. The proportion of evaluable participants who are alive and without radiographic disease progression at 6 and 12 months after treatment initiation. Calculated based on Kaplan-Meier estimates of rPFS. Participants who discontinue study treatment for reasons other than radiographic disease progression will continue to undergo imaging until documented radiographic progression, initiation of non-protocol systemic treatment, withdrawal from the study, or death, whichever occurs first. Participants without an rPFS event will be censored at the date of their last available tumor assessment. | ClinicalTrials.gov |
| Secondary | Proportion of Participants with Treatment-emergent Adverse Events (TrAE) | Up to 40 days after treatment discontinuation | Proportion of participants with treatment-emergent adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 6.0) will be reported. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With a >=50% Decline in Prostate Specific Antigen (PSA) | Up to 5 years | The proportion of participants who achieve greater than 50% decline in baseline PSA (baseline drawn on C1D1), at any point during treatment. Proportion and 95% confidence interval will be reported. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With a >=90% Decline in Prostate Specific Antigen (PSA) | Up to 5 years | The proportion of participants who achieve greater than 90% decline in baseline PSA (baseline drawn on C1D1), at any point during treatment. Proportion and 95% confidence interval will be reported. | ClinicalTrials.gov |
| Secondary | Median Overall Survival (OS) | Up to 5 years | Overall Survival (OS) is defined as the overall survival time as the time that elapses between the initiation of trial therapy C1D1 and the date of death from any cause for all evaluable patients. Participants alive at the last follow-up will be censored at the date of last known contact. Calculated based on Kaplan-Meier estimates of OS. | ClinicalTrials.gov |
| Secondary | Proportion of Participants Achieving ≥50% Reduction in Circulating Tumor DNA (ctDNA) Fraction | Up to 5 years | The proportion of participants who achieve ≥50% reduction in circulating tumor DNA (ctDNA) fraction from baseline (baseline drawn on C1D1) at any time during treatment. Proportion and 95% confidence interval will be reported. | ClinicalTrials.gov |
| Secondary | Proportion of participants with detectable ctDNA achieving molecular complete response rate | Up to 5 years | Molecular complete response is defined as the proportion of participants with detectable ctDNA at baseline who convert to undetectable ctDNA during treatment. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)