Trials / Active Not Recruiting
Active Not RecruitingNCT06229366
[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer
[Ac-225]-PSMA-62 Phase I/II Clinical Trial to Characterize Efficacy, Safety, Tolerability, and Dosimetry in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer (ACCEL)
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 142 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
ACCEL is a multicenter, open label phase Ia/Ib/II study of \[Ac-225\]-PSMA-62 in participants with prostate-specific membrane antigen (PSMA)-positive prostate cancer.
Detailed description
The primary aim of the phase Ia study is to evaluate the safety and tolerability of \[Ac-225\]-PSMA-62 to determine the maximum tolerated dose (MTD). The primary aim of the randomized phase Ib dose optimization is to determine the recommended phase II doses (RP2D) for patients with mCRPC and OmHSPC. The aim of the phase II study for patients with mCRPC is to evaluate the efficacy of \[Ac-225\]-PSMA-62.
Conditions
- Prostate Cancer
- Metastatic Castration-resistant Prostate Cancer
- Oligometastatic Prostate Carcinoma
- Hormone Sensitive Prostate Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [Ac-225]-PSMA-62 (mCRPC) | Phase Ia: Administered intravenously per dose escalation scheme. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 6-week cycle for up to 4 cycles. Phase Ib: Administered intravenously at MTD or one dose level below MTD. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 6-week or 4-week cycle, for a total of 4 cycles. |
| DRUG | [Ac-225]-PSMA-62 (OmHSPC) | Phase Ia: Administered intravenously per dose escalation scheme. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 8-week cycle for up to 2 cycles. Phase Ib: Administered intravenously at MTD or one dose level below MTD. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 8-week cycle, for a total of 2 cycles. |
Timeline
- Start date
- 2024-04-03
- Primary completion
- 2027-09-01
- Completion
- 2032-12-01
- First posted
- 2024-01-29
- Last updated
- 2025-12-22
Locations
7 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT06229366. Inclusion in this directory is not an endorsement.