M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)

Launched by EMD SERONO RESEARCH & DEVELOPMENT INSTITUTE, INC. · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial, called DDRiver 501, is studying a new treatment called M9466, both on its own and together with another medication called tuvusertib, for patients with advanced solid tumors—these are types of cancer that form in organs or tissues. The goal of the study is to find out how safe these treatments are, how well they work in the body, and if they can help improve patients' conditions. The trial is currently recruiting participants who are 18 years or older and have cancer that has not responded to standard treatments or for which no standard treatment is available. To be eligible, participants should also have a good overall health status and a life expectancy of more than six months.

If you decide to participate, you will receive treatment until your cancer progresses or you choose to stop. During the first two cycles of treatment, you will visit the clinic every week, and then less frequently in the following cycles. The study will include follow-up visits to monitor your safety and health after treatment ends. It's important to know that certain health conditions may exclude you from participating, such as ongoing side effects from previous treatments or specific serious health issues. This trial offers an opportunity for patients who have few other options, and the information gathered could help improve future cancer treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Module 1 Part A1 and Module 2 Part A1: Locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator
• • Eastern Cooperative Oncology Group Performance Status less than or equal to (\<=) 1
• • Life expectancy of more than 6 months
• • Have adequate hematologic function
• • Participants who received chemotherapy, extensive radiotherapy, biological therapy (e.g. antibodies) or investigational agents will have a washout period of 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives whichever is shorter, prior to starting study intervention with M9466 (± tuvusertib)
• * Module 3 Part A1:
• • Histologically or pathologically confirmed diagnosis of prostate cancer
• • Metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI
• • Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC) are allowed. For mCRPC, serum testosterone levels ≤ 50 /dL (≤ 1.75 nmol/L).
• • Ongoing ADT with a GnRH agonist or antagonist for participants who have not undergone bilateral orchiectomy must be initiated before first dose and must continue throughout the study.
• • Candidate for treatment with ·abiraterone acetate.
• • Prior anticancer therapy allowed for mHSPC or mCRPC
• • Other protocol defined inclusion criteria could apply
• Exclusion Criteria:
• • Persistence of Adverse Events related to any prior treatments that have not recovered to Grade less than 1 by NCI Common Terminology Criteria for Adverse Events- v5.0 unless AEs are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator (e.g. neuropathy or alopecia)
• • Participant has a history of malignancy within 5 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)
• • Participants with known brain metastases, except if clinically controlled, which is defined as individuals with Central Nervous System (CNS) tumors that have been treated, are asymptomatic and who have discontinued steroids (for the treatment of CNS tumors) for more than 28 days
• • Serious Gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease (including exocrine pancreatic insufficiency requiring pancreatic enzyme replacement therapy), and/or other situations that may preclude adequate absorption of oral medications
• • Cerebrovascular accident or stroke
• * Module 3 only:
• * Current evidence of any of the following:
• • 1. Any medical condition that would make prednisone (or equivalent) use contraindicated.
• • 2. Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone (or equivalent) once daily.
• • History of uncontrolled pituitary or adrenal dysfunction
• • Hypokalemia
• • Other protocol defined exclusion criteria could apply

Trial Officials