Ovarian Cancer Clinical Trial

M9466 as Single Agent or in Combination With Tuvusertib in Advanced Solid Tumors (DDRiver 501)

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 as monotherapy or in combination 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.

View Eligibility Criteria

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)
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
Other protocol defined exclusion criteria could apply

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT06421935

Recruitment Status:

Not yet recruiting

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 2 Locations for this study

See Locations Near You

Please Contact U.S. Medical Information
Rockland Massachusetts, 02370, United States More Info
Please Contact U.S. Medical Information
Contact
888-275-7376
[email protected]
Please Contact the Communication Center
Darmstadt , 64293, Germany More Info
Please Contact the Communication Center
Contact
+49 6151 72 5200
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT06421935

Recruitment Status:

Not yet recruiting

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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