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New treatment option for PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)...
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?
AMO959 is an investigational medicine, being studied as a potential treatment for psma-positive metastatic castration resistant prostate cancer (mcrpc) with prior exposure to one prior arpi who are candidates for taxane-based chemotherapy.
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
- The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter referred to as AAA617) with an androgen receptor pathway inhibitor (ARPI) in participants with metastatic castration resistant prostate cancer (mCRPC) who have failed one prior ARPI and with or without prior taxane exposure, and (b) in Phase II evaluate the preliminary efficacy of AMO959 in combination with AAA617 and ARPI in participants with mCRPC who have failed one prior ARPI, but who have not yet been exposed to taxane treatment.
- 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. neuroendocrine, intraductal...
- Phase Ib: Prior exposure of up to 1 line of taxane-based chemotherapy is permissible. Phase II: Participants must not have received taxane-based...
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
- Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI), based on...
- 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; 1.0 ng/mL is the minimal starting value if confirmed rise in PSA is the only indication...
- 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's taking place
- Los Angeles, California, 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
- Cona, FE, Italy
- Milan, MI, Italy
- Naples, Italy
- Sapporo, Hokkaido, Japan
- Granada, Andalusia, Spain
- L'Hospitalet de Llobregat, Barcelona, Spain
- Barcelona, Spain
+ 1 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 - 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?
Study sites include Los Angeles, California, United States; El Paso, Texas, United States; Murray, Utah, United States; Malvern, Victoria, Australia; Melbourne, Victoria, Australia; Murdoch, Western Australia, Australia and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.