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Clinical Trials/NCT06719973
NCT06719973
Withdrawn
Phase 1

An Open Label, Multicenter, Phase 1 Study of the PARP1 Inhibitor M9466 in Combination With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)

EMD Serono Research & Development Institute, Inc.0 sites54 target enrollmentStarted: May 14, 2025Last updated:
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ConditionsAdvanced Solid Tumors
InterventionsM9466CarboplatinEtoposideAtezolizumabM9446
DrugsM9466CarboplatinEtoposideAtezolizumabM9446

Overview

Phase
Phase 1
Status
Withdrawn
Enrollment
54
Primary Endpoint
Module 1 and Module 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment Related TEAEs
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Module 1 (Dose Finding): M9466 + Carboplatin

Experimental

Intervention: M9466 (Drug)

Module 1 (Dose Finding): M9466 + Carboplatin

Experimental

Intervention: Carboplatin (Drug)

Module 2 Part A (Dose Reassessment): M9466 + Carboplatin + Etoposide + Atezolizumab

Experimental

Intervention: Etoposide (Drug)

Module 2 Part A (Dose Reassessment): M9466 + Carboplatin + Etoposide + Atezolizumab

Experimental

Intervention: Atezolizumab (Drug)

Module 2 Part A (Dose Reassessment): M9466 + Carboplatin + Etoposide + Atezolizumab

Experimental

Intervention: M9446 (Drug)

Module 2 Part A (Dose Reassessment): M9466 + Carboplatin + Etoposide + Atezolizumab

Experimental

Intervention: Carboplatin (Drug)

Module 2 Part B (Dose Expansion): M9466 + Carboplatin + Etoposide + Atezolizumab

Experimental

Intervention: Etoposide (Drug)

Module 2 Part B (Dose Expansion): M9466 + Carboplatin + Etoposide + Atezolizumab

Experimental

Intervention: Atezolizumab (Drug)

Module 2 Part B (Dose Expansion): M9466 + Carboplatin + Etoposide + Atezolizumab

Experimental

Intervention: M9446 (Drug)

Module 2 Part B (Dose Expansion): M9466 + Carboplatin + Etoposide + Atezolizumab

Experimental

Intervention: Carboplatin (Drug)

Outcomes

Primary Outcomes

Module 1 and Module 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment Related TEAEs

Time Frame: Time from signing Informed Consent Form (ICF) up to 30 days after end of study intervention (approximately assessed up to 24 months)

Module 1 and Module 2: Number of Participants with Dose-limiting Toxicity (DLT)

Time Frame: Day 1 up to Day 21 of Cycle 1 (each cycle is of 21 days)

Secondary Outcomes

  • Module 1 and Module 2: Pharmacokinetic (PK) Plasma Concentration of M9466(Pre-dose up to 6 hours post-dose on Cycle 1 Day 1; Pre-dose on Cycle 1 Day 4 and Cycle 1 Day 8 (each cycle is of 21 days))
  • Module 1 and Module 2: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Assessed by Investigator(Time from first treatment of study intervention up to planned assessment at 24 months)
  • Module 1 and Module 2: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Assessed by the Investigator(Time from first treatment of study intervention up to planned assessment at 24 months)
  • Module 1 and Module 2: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Assessed by Investigator(Time from first treatment of study intervention up to planned assessment at 24 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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