AMO959 + AAA617 for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines a new combination of treatments for advanced prostate cancer that continues to progress despite standard therapies. Researchers aim to assess the safety and effectiveness of these treatments in individuals whose cancer has spread and who have unsuccessfully tried at least one hormone therapy. The trial includes different groups testing combinations of the drugs AMO959 (experimental treatment), AAA617 (experimental treatment), and hormone inhibitors like abiraterone or enzalutamide. Potential participants are those with metastatic prostate cancer, worsening symptoms during a specific hormone treatment, and no prior exposure to certain chemotherapy treatments. As a Phase 1, Phase 2 trial, this research seeks to understand the treatment's effects and measure its initial effectiveness, offering participants a chance to contribute to groundbreaking advancements in prostate cancer therapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of AMO959 and AAA617 is generally well-tolerated. Common side effects include tiredness, dry mouth, and nausea, which are typical and usually not severe. More serious side effects might occur but are less common, making the treatment manageable for most patients.
When combined with another drug like abiraterone or enzalutamide, the safety profile remains similar. Both abiraterone and enzalutamide have been used in treating prostate cancer and are generally considered safe, though they can cause side effects such as increased blood pressure or tiredness.
Overall, past research suggests these treatments are reasonably safe, but monitoring for any side effects during the trial is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for prostate cancer because they target the disease in new and potentially more effective ways. Unlike standard treatments that primarily focus on hormone suppression, AMO959 and AAA617 work together to attack cancer cells directly with a unique combination approach. AMO959 is designed to enhance the cancer-fighting effects of AAA617, potentially leading to better outcomes. Additionally, combining these with ARPIs like abiraterone or enzalutamide may offer a more comprehensive attack on cancer cells, possibly increasing the efficacy compared to current options. This combination therapy approach has the potential to improve patient outcomes by targeting the cancer more aggressively.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
This trial will evaluate the combination of AAA617 and AMO959 for treating advanced prostate cancer that no longer responds to hormone therapy. Research has shown that AAA617, also known as 177Lu-PSMA-617, significantly lowers prostate-specific antigen (PSA) levels in many patients. AMO959 activates a key part of cell metabolism, potentially stopping cancer cell growth. In this trial, some participants will receive AAA617 and AMO959 together, while others will receive these drugs combined with either abiraterone or enzalutamide, which block cancer growth signals. Studies suggest that using AAA617 with these additional drugs may better prevent cancer from worsening. Overall, these findings support the potential of using AMO959 and AAA617 together to manage this type of prostate cancer.12367
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase Ib: Escalation
Participants receive AMO959 monotherapy followed by AMO959 with AAA617 to determine the recommended dose for expansion
Phase II: Treatment
Participants receive AAA617 and AMO959 with ARPI, repeated every 6 weeks for a maximum of 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AAA617
- Abiraterone
- AMO959
- Enzalutamide
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Participants will receive AAA617 every 6 weeks for a maximum of 6 cycles, with ARPI (abiraterone or enzalutamide) administered continuously starting on day 1.
Participants will receive AAA617 on day 1 followed by AMO959 BID (days 2-15), repeated every 6 weeks, for a maximum of 6 cycles with an ARPI (abiraterone or enzalutamide) administered continuously starting on day 1.
Participants will receive AAA617 on day 1 followed by AMO959 BID (days 2-15), repeated every 6 weeks, for a maximum of 6 cycles with an ARPI (abiraterone or enzalutamide administered continuously starting on day 1.
Participants will receive AAA617 on day 1 followed by AMO959 BID (days 2-15), repeated every 6 weeks, for a maximum of 6 cycles with an ARPI (abiraterone or enzalutamide) administered continuously starting on day 1.
Participants will receive a single dose of AMO959 on Day 1 (fed), followed by 2-day washout, then AMO959 BID (fasted) for 14 days followed by 2-day washout and AAA617+AMO959 (fasted) every 6 weeks for a maximum of 6 cycles.
Participants will receive AMO959 BID for first 14 days followed by AAA617+AMO959 every 6 weeks for a maximum of 6 cycles.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Citations
Efficacy, toxicity, and clinical outcomes of 177Lu-PSMA ...
177 Lu-PSMA-617 at 5.5 GBq per cycle was safe and effective, achieving survival comparable to studies using 7.4 GBq with fewer severe ...
A Phase Ib/II Open-label, Multi-center Study of AMO959 ...
A Phase Ib/II Open-label, Multi-center Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With an Androgen ...
3.
ctv.veeva.com
ctv.veeva.com/study/a-phase-ib-ii-open-label-study-of-amo959-with-lutetium-177lu-vipivotide-tetraxetan-aaa617-in-comA Phase Ib/II Open-label Study of AMO959 With Lutetium ...
Participants will receive AAA617 on day 1 followed by AMO959 BID (days 2-15), repeated every 6 weeks, for a maximum of 6 cycles with an ARPI ( ...
NCT05849298 | A Phase II Study of AAA617 Alone and ...
The purpose of this study is to evaluate the efficacy and safety of AAA617 alone (Lutetium [177Lu] vipivotide tetraxetan) and in combination with an ...
A Phase Ib/II Open-label Study of AMO959 With Lutetium ...
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 ...
CAMO: AMO959 with AAA617 in PSMA-positive mCRPC
This study is being done to see if different amounts of a medicine called AMO959 can be safely given with another treatment called AAA617, and sometimes with a ...
Outcomes for [ 177 Lu]Lu-PSMA-617 with and Without ...
This study aimed to assess the efficacy of [177Lu]Lu-PSMA-617 in patients with and without the concurrent use of an ARPI. Methods: We analyzed ...
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