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NCT06719973 | NOT YET RECRUITING | Advanced Solid Tumors

Phase 1 Study of M9466 Combined With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)
Sponsor:

EMD Serono Research & Development Institute, Inc.

Brief Summary:

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 in combinations with carboplatin in advanced or metastatic refractory solid tumor and with the standard of care (carboplatin, etoposide, and atezolizumab) in treatment-naïve ES-SCLC. The results will support any investigation of carboplatin-based combination anticancer treatments with M9466 as well as the selection of a RP2D of M9466 in combination with carboplatin, etoposide, and atezolizumab for a subsequent ES-SCLC study.

Condition or disease

Advanced Solid Tumors

Intervention/treatment

M9466

Carboplatin

Etoposide

Atezolizumab

M9446

M9446

Carboplatin

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 54 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Open Label, Multicenter, Phase 1 Study of the PARP1 Inhibitor M9466 in Combination With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2027-10-06
Estimated Study Completion Date : 2027-10-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Module 1: Locally advanced or metastatic solid tumors that are refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator (that is \[i.e.\] participants who have exhausted all standard of care options according to International Guidelines), which may convey clinical benefit from the combination treatment with M9466 and carboplatin and have not received more than 3 lines of prior anticancer therapy in the advanced/metastatic setting Module 2: Histologically or cytologically confirmed treatment-naïve, de novo, extensive stage small cell lung cancer (ES-SCLC), who have no history of systemic treatment for the disease. Participant must be considered suitable to receive carboplatin, etoposide, and atezolizumab as first-line treatment for ES-SCLC
  • * Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to (\<=) 1 (ECOG PS 2 eligible if considered related to SCLC tumor load in Module 2)
  • * Have adequate hematological, hepatic, and renal function as defined in the protocol
  • * Other protocol defined inclusion criteria could apply
Exclusion Criteria
  • * Module 1: Persistence of AEs related to any prior treatments that have not recovered to Grade \<= 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 unless AEs are clinically non-significant and /or stable on supportive therapy in the opinion of the Investigator (for example \[e.g.\] neuropathy or alopecia)
  • * Module 2: Participant has a history of malignancy within 3 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, 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 CNS tumors that are asymptomatic and who do not require steroids for the treatment of CNS tumors
  • * Life expectancy of less than (\<) 3 months
  • * Other protocol defined exclusion criteria could apply
Phase 1 Study of M9466 Combined With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)

Location Details

NCT06719973

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How to Participate

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Locations

Not yet recruiting

Japan,

National Cancer Center Hospital - Dept of Respiratory Medicine

C-Cry, Japan, 104-0045