M9466 + Tuvusertib for Cancer

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: EMD Serono Research & Development Institute, Inc.

Must be taking: GnRH agonist/antagonist

Must not be taking: Steroids

Disqualifiers: Brain metastases, Stroke, Gastrointestinal disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.

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.

Research Team

Medical Responsible

Principal Investigator

EMD Serono Research & Development Institute, Inc.

Eligibility Criteria

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

I can carry out all my self-care but cannot do heavy physical work.

Life expectancy of more than 6 months

My blood counts are within a healthy range.

Exclusion Criteria

I have had a stroke.

Other protocol defined exclusion criteria could apply

I still have side effects from previous treatments, but they are not severe or are stable with current treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive M9466 alone or in combination with tuvusertib or an ARPi. Treatment continues until disease progression, death, discontinuation, or End of Study.

Until disease progression or end of study

Weekly visits for the first 2 cycles, then every 3 weeks

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

Safety Follow-up/Discontinuation Visit

Treatment Details

Interventions

• M9466 (Monoclonal Antibodies)
• Tuvusertib (Other)

Trial Overview The trial is testing M9466 alone or combined with Tuvusertib on patients with advanced solid tumors. It aims to assess safety, how well it's tolerated, how it affects and moves within the body (pharmacokinetics/pharmacodynamics), and its initial effectiveness.

Participant Groups

Group I: M9466 with AA-P(abiraterone acetate and prednisone or prednisolone) Experimental Treatment 2 Interventions

Group II: M9466 plus Tuvusertib Experimental Treatment 2 Interventions

Group III: M9466 Monotherapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

EMD Serono Research & Development Institute, Inc.

Lead Sponsor

Trials

86

Recruited

22,700+

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

Trials

449

Recruited

122,000+

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