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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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 will be administered intravenously on Day 1 of each 21-day cycle.
Etoposide will be administered intravenously as per standard of care.
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)
Module 1 and Module 2: Pharmacokinetic (PK) Plasma Concentration of M9466
Time frame: 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 frame: 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 frame: 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 frame: Time from first treatment of study intervention up to planned assessment at 24 months
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Atezolizumab will be administered intravenously as per standard of care.
M9446 dose will be further investigated in Module 2 Part A of the study.
M9446 recommended Dose for Expansion (RDE) will be further investigated in Module 2 Part B of the study.
Carboplatin will be administered intravenously as per standard of care.