Clinical trial for PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With...
Official 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
ClinicalTrials.gov ID: NCT07226986
What this study is testing
What is AMO959?
an investigational drug being studied for PSMA‑positive metastatic castration‑resistant prostate cancer in patients who have had one prior ARPI and may need taxane chemotherapy is designed to inhibit DNA damage response pathways, potentially preventing cancer cells from repairing DNA damage
Also referred to as BY1298, BY101298.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase Ib will check safety, side effects, and how the drug behaves in the body. Phase II will look at early signs that the combination may work against the cancer.
- Who it's for
- Men with PSMA‑positive metastatic castration‑resistant prostate cancer who have already tried one androgen‑receptor pathway inhibitor, whether or not they have had taxane chemotherapy.
- What's involved
- You will receive the experimental drug AMO959 together with a lutetium‑177 labeled PSMA‑617 infusion and continue your current AR pathway inhibitor, plus regular clinic visits for blood tests, scans and safety checks.
- Time commitment
- The study runs for several months and includes multiple treatment visits and follow‑up appointments.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Signed informed consent must be obtained prior to participation in the study.
- Participants must be adults ≥ 18 years of age.
- Participants must have an ECOG performance status of 0 to 2.
- Participants must have histologically confirmed adenocarcinoma of the prostate. Participants with other histology (e.g.
- Phase Ib: Prior exposure of up to 1 line of taxane-based chemotherapy is permissible.
You likely can't join if
- Concurrent local (radiation therapy to the prostate with curative intent or other prostate antineoplastic ablative procedures) or systemic (hormonal...
- Prior treatment with any RLT or PSMA-targeted agents (approved or investigational)
- Any other investigational agents within 28 days prior to first dose of any study treatment
- Concurrent serious medical conditions that may interfere with study procedures or followup
- Participants with a history of CNS metastases must have received therapy (surgery, whole brain radiation therapy, stereotactic radiosurgery) and be...
See the full eligibility criteria
- Signed informed consent must be obtained prior to participation in the study.
- Participants must be adults ≥ 18 years of age.
- Participants must have an ECOG performance status of 0 to 2.
- Participants must have histologically confirmed adenocarcinoma of the prostate. Participants with other histology (e.g. neuroendocrine, intraductal subtype) are not eligible.
- Phase Ib: Prior exposure of up to 1 line of taxane-based chemotherapy is permissible. Phase II: Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).
- Participants must have PSMA-PET positive disease assessed by using a PSMA imaging agent that is approved as per protocol and are eligible as determined by the sponsor's central reading rules.
- Castration level of testosterone (\< 50 ng/dL), and/or use of concomitant ADT
- Serum/plasma PSA progression is defined as 2 increases in PSA measured at least 1 week apart. The minimal start value is 2.0 ng/mL
- Soft-tissue progression defined PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016).
- Progression of bone disease: 2 new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria Scher et al 2016). Key
- Concurrent local (radiation therapy to the prostate with curative intent or other prostate antineoplastic ablative procedures) or systemic (hormonal ablation, chemotherapy, immunotherapy, , RLTs) antineoplastic...
- Prior treatment with any RLT or PSMA-targeted agents (approved or investigational)
- Any other investigational agents within 28 days prior to first dose of any study treatment
- Concurrent serious medical conditions that may interfere with study procedures or followup
- Participants with a history of CNS metastases must have received therapy (surgery, whole brain radiation therapy, stereotactic radiosurgery) and be neurologically stable, asymptomatic, and not taking corticosteroids for...
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Durham, North Carolina, United States
- El Paso, Texas, United States
- Murray, Utah, United States
- Malvern, Victoria, Australia
- Melbourne, Victoria, Australia
- Murdoch, Western Australia, Australia
- Bordeaux, France
- Clermont-Ferrand, France
- Nantes, France
- Villejuif, France
- Dresden, Saxony, Germany
- Essen, Germany
- München, Germany
- Stuttgart, Germany
- Cona, FE, Italy
- Milan, MI, Italy
- Naples, Italy
- Sapporo, Hokkaido, Japan
- Fukuoka, Japan
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Durham, North Carolina, United States; El Paso, Texas, United States; Murray, Utah, United States; Malvern, Victoria, Australia; Melbourne, Victoria, Australia and 18 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.