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

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

NCT ID: NCT06421935

Condition: Advanced Solid Tumor

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
PARP inhibitor
castration-resistant prostate cancer
ovarian cancer

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: M9466
Description: Participants will be administered M9466 orally.
Arm group label: M9466 Monotherapy
Arm group label: M9466 plus Tuvusertib

Other name: HRS-1167;

Intervention type: Drug
Intervention name: Tuvusertib
Description: Participants will be administered Tuvusertib orally.
Arm group label: M9466 plus Tuvusertib

Other name: Substance code MSC2584415A; also known as M1774, VXc-400, or VR 1363004

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: NEXT Oncology - PARENT

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Contact:
Email: irodriguez@nextoncology.com

Investigator:
Last name: Ildefonso Ismael Rodriguez Rivera
Email: Principal Investigator

Facility:
Name: Cancer Institute Hospital of JFCR

Address:
City: Koto-ku
Zip: 135-8550
Country: Japan

Status: Recruiting

Contact:
Email: shigehisa.kitano@jfcr.or.jp

Investigator:
Last name: Shigehisa Kitano
Email: Principal Investigator

Start date: August 7, 2024

Completion date: March 26, 2026

Lead sponsor:
Agency: EMD Serono Research & Development Institute, Inc.
Agency class: Industry

Collaborator:
Agency: Merck KGaA, Darmstadt, Germany
Agency class: Industry

Source: EMD Serono

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06421935
https://clinicaltrials.emdgroup.com/en