M9466 + Tuvusertib for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cancer treatment called M9466, both alone and with other drugs, to assess its safety and effectiveness in people with advanced solid tumors. The trial aims to understand the drug's effects on the body and whether it shows early signs of treating cancer. Suitable candidates for this trial have advanced cancer unresponsive to standard treatments or prostate cancer that has spread. Participants will initially visit the study site weekly, then every three weeks, until their condition worsens or they exit the study. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) of 4 weeks for most prior treatments before starting the study drugs. If you are on ongoing ADT (androgen deprivation therapy) for prostate cancer, you must continue it throughout the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both M9466 and tuvusertib appear safe for treating advanced solid tumors.
Studies have found that M9466 is generally well-tolerated, with patients usually not experiencing severe side effects. Its good safety record suggests it is suitable for further testing in humans.
For tuvusertib, research indicates that its safety is manageable, meaning side effects can typically be controlled with proper care. Patients in earlier studies demonstrated that the treatment can effectively target cancer, highlighting its potential benefits.
Overall, both treatments have shown safety in earlier studies, but this trial remains in the early stages. Researchers continue to closely monitor the safety of these treatments in humans.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer new ways to tackle cancer. M9466 plus Tuvusertib is unique as it combines two drugs that may work together to enhance anti-cancer effects, potentially leading to more effective treatment compared to standard options like chemotherapy or immunotherapy. M9466 Monotherapy focuses on a novel active ingredient, M9466, which might target cancer cells differently, offering hope for patients who do not respond well to existing treatments. The combination of M9466 with AA-P (abiraterone acetate and prednisone or prednisolone) introduces a promising strategy by mixing a new agent with a well-known hormone therapy, possibly improving outcomes for patients with hormone-sensitive cancers.
What evidence suggests that this trial's treatments could be effective for advanced solid tumors?
Research has shown that M9466, a drug targeting the protein PARP1, has promising effects against tumors in patients with advanced solid cancers. Studies have found it to be generally safe and well-tolerated. In this trial, some participants will receive M9466 as a monotherapy, while others will receive it combined with Tuvusertib. Tuvusertib disrupts the cancer cell cycle, preventing tumor cells from repairing themselves and leading to their death. Although no patients in early studies had a complete response, some experienced disease stabilization for longer periods. Together, these treatments target specific cancer pathways that may help slow tumor growth.12467
Who Is on the Research Team?
Medical Responsible
Principal Investigator
EMD Serono Research & Development Institute, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals with advanced solid tumors. Participants will receive treatment until their disease progresses, they pass away, decide to leave the study, or when the study ends. They'll visit the clinic weekly at first and then every three weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive M9466 alone or in combination with tuvusertib or an ARPi. Treatment continues until disease progression, death, discontinuation, or End of Study.
End of Treatment
An End of Treatment Visit is conducted to assess participant status at the conclusion of the treatment phase.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- M9466
- Tuvusertib
Find a Clinic Near You
Who Is Running the Clinical Trial?
EMD Serono Research & Development Institute, Inc.
Lead Sponsor
Miguel Fernández Alcalde
EMD Serono Research & Development Institute, Inc.
Chief Executive Officer
Bachelor’s Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master’s Degree in Management from IESE Business School
Danny Bar-Zohar
EMD Serono Research & Development Institute, Inc.
Chief Medical Officer since 2022
MD
Merck KGaA, Darmstadt, Germany
Industry Sponsor
Danny Bar-Zohar
Merck KGaA, Darmstadt, Germany
Chief Medical Officer since 2022
MD
Belén Garijo
Merck KGaA, Darmstadt, Germany
Chief Executive Officer since 2021
MD