Trial · NCT07226986
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
NCT07226986, Phase 1, Phase 2, Recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC. Trials, record NCT07226986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07226986
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
- NCT number
- NCT07226986
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 123 participants, estimated
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy
- Interventions
- AMO959, AAA617, Enzalutamide, Abiraterone
- First posted
- 2025-11-12
- Last updated
- 2026-10-15
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib: Incidence rate of Dose-limiting toxicities (DLTs) | Up to 42 days after the first AAA617 dose administration | Incidence of dose limiting toxicities (DLTs) with AMO959 in combination with AAA617 +/- ARPI A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the evaluation period and meets any of the criteria specified in the protocol. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading. |
| Primary | Phase Ib: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From date of start of study treatment, assessed up to approximately 45 months | Incidence of adverse events by type, frequency, and severity, as graded by the NCI CTCAE version 5.0. |
| Primary | Phase Ib: Number of Participants with dose adjustments | From date of start of study treatment, assessed up to approximately 24 months | The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation). |
| Primary | Phase Ib: Dose Intensity | From date of start of study treatment, assessed up to approximately 24 months | Dose intensity (computed as the ratio of actual cumulative dose received and actual duration of exposure) and the relative dose intensity (computed as the ratio of dose intensity and planned dose intensity). |
| Primary | Phase Ib: Duration of exposure to each study drug | From date of start of study treatment, assessed up to approximately 24 months | Duration of exposure (in months) to each study drug. |
| Primary | Phase II: Biochemical Response (PSA50) | From date of start of study treatment, assessed up to approximately 24 months | Biochemical response (PSA50), defined as the proportion of participants who achieved a ≥ 50% decrease in PSA from baseline at any time during the treatment period prior to start of new anti-cancer therapy that is confirmed by a second PSA measurement ≥ 4 weeks later. |
| Secondary | Prostate Specific Antigen 90 (PSA90) response | From date of start of study treatment, assessed up to approximately 24 months | PSA90 response is defined as the proportion of participants who have achieved a ≥ 90% decrease in PSA from baseline at any time during the treatment period prior to start of new anti-cancer therapy that is confirmed by a second PSA measurement ≥4 weeks later. |
| Secondary | Phase Ib: Prostate Specific Antigen 50 (PSA50) response | From date of start of study treatment, assessed up to approximately 24 months | PSA50 response is defined as the proportion of participants who have achieved a ≥ 50% decrease in PSA from baseline at any time during the treatment period prior to the start of new anti-cancer therapy, confirmed by a second PSA measurement ≥4 weeks later. |
| Secondary | Phase Ib and Phase II: Radiographic progression-free survival (rPFS) | From date of start of study treatment (Phase Ib) / randomization (Phase II), assessed up to approximately 24 months | Radiographic progression- free survival (rPFS) is defined as the time from the date of start of study treatment (Phase Ib) / randomization (Phase II) to the date of first documented radiographic disease progression using conventional imaging and Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 criteria (Scher et al 2016) or death due to any cause, whichever occurs first. |
| Secondary | Phase Ib and Phase II: Overall Response Rate (ORR) | From date of start of study treatment (Phase Ib) / randomization (Phase II), assessed up to approximately 24 months | Overall Response Rate (ORR) is defined as the proportion of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) in soft tissue based on tumor response data and according to PCWG3-modified RECIST v1.1, in the absence of bone progression as per PCWG3. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes0
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/NCT07226986
GET https://conductscience.org/api/trials/v1/NCT07226986/registered?page=2