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

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT06719973
Phase
PHASE1
Status
Withdrawn

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • M9466 — DRUG
    Participants will receive an escalating doses of M9466 orally in 21-day cycles until disease progression, intolerable toxicity, death, withdrawal of study or study consent, lost to follow-up, or end of study.
  • Carboplatin — DRUG
    Carboplatin will be administered intravenously on Day 1 of each 21-day cycle.
  • Etoposide — DRUG
    Etoposide will be administered intravenously as per standard of care.
  • Atezolizumab — DRUG
    Atezolizumab will be administered intravenously as per standard of care.
  • M9446 — DRUG
    M9446 dose will be further investigated in Module 2 Part A of the study.
  • M9446 — DRUG
    M9446 recommended Dose for Expansion (RDE) will be further investigated in Module 2 Part B of the study.
  • Carboplatin — DRUG
    Carboplatin will be administered intravenously as per standard of care.

Study Details

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.

Key Dates

Start date
May 14, 2025
Status verified
Jun 2025
Primary completion
May 14, 2025
Completion
May 14, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1 (Dose Finding): M9466 + Carboplatin
  • Experimental: Module 2 Part A (Dose Reassessment): M9466 + Carboplatin + Etoposide + Atezolizumab
  • Experimental: Module 2 Part B (Dose Expansion): M9466 + Carboplatin + Etoposide + Atezolizumab

Primary Outcome Measure

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) ]

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