M9466 + Carboplatin for Solid Tumors
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: EMD Serono Research & Development Institute, Inc.
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for adults with advanced solid tumors that haven't responded to treatment, or those newly diagnosed with ES-SCLC who haven't started treatment. Participants must be able to handle the side effects of chemotherapy.Inclusion Criteria
I have small cell lung cancer that has not been treated and is suitable for specific first-line treatments.
Treatment Details
The study tests M9466 combined with carboplatin in patients with refractory solid tumors and adds standard care (carboplatin, etoposide, atezolizumab) for new ES-SCLC cases. It aims to find a safe dose of M9466 and see how well it works.
3Treatment groups
Experimental Treatment
Group I: Module 2 Part B (Dose Expansion): M9466 + Carboplatin + Etoposide + AtezolizumabExperimental Treatment4 Interventions
Group II: Module 2 Part A (Dose Reassessment): M9466 + Carboplatin + Etoposide + AtezolizumabExperimental Treatment4 Interventions
Group III: Module 1 (Dose Finding): M9466 + CarboplatinExperimental Treatment2 Interventions
Atezolizumab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Tecentriq for:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
🇪🇺 Approved in European Union as Tecentriq for:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a clinic near you
Research locations nearbySelect from list below to view details:
Please Contact U.S. Medical InformationBillerica, MA
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Who is running the clinical trial?
EMD Serono Research & Development Institute, Inc.Lead Sponsor
Merck KGaA, Darmstadt, GermanyIndustry Sponsor