Iadademstat + SBRT With Atezo in ES-SCLC
This study is testing a new combination treatment for extensive stage small cell lung cancer (ES-SCLC) that has returned or progressed after previous chemotherapy. The treatment involves three parts: iadademstat (an oral drug), atezolizumab (an IV infusion that works by checkpoint blockade, which helps your immune system fight cancer), and SBRT (a type of radiation therapy). Researchers want to see how safe this combination is and if it causes any serious side effects. You may be eligible if you are at least 18 years old, weigh at least 50 kg, and have ES-SCLC that has been previously treated with platinum-based chemotherapy. This study plans to enroll 15 participants.
- Study design
- This is a Phase 1b, open-label study, meaning both you and your doctors will know which treatments you are receiving. It is a dose-escalation study, meaning the dose of iadademstat may be adjusted. There are 15 planned participants.
- What's involved
- Iadademstat is taken orally. Atezolizumab is given by IV infusion every 28 days. SBRT radiation therapy is given after starting iadademstat and atezolizumab, ideally between Day 8 and Day 15 of the first cycle.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for safety are measured at 35 days after the first dose of study drug on Cycle 1 Day 1.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Iadademstat + SBRT With Atezo in ES-SCLC
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Annie Chiang, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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What this trial measures
- Frequency of Dose-Limiting Toxicities (DLTs) in patients treated with iadademstat combined with atezolizumab and SBRT35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
The number of participants experiencing dose-limiting toxicities (DLTs) during the study period will be recorded, providing a measure of how frequently DLTs occur when iadademstat is combined with atezolizumab and SBRT.
- Rate of Dose-Limiting Toxicities (DLTs) in patients treated with iadademstat combined with atezolizumab and SBRT35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
The proportion of participants experiencing dose-limiting toxicities (DLTs), expressed as a percentage of the total participants, will be calculated. This measure aims to quantify the incidence rate of DLTs in the study population.
- Grade of Dose-Limiting Toxicities (DLTs) in patients treated with iadademstat combined with atezolizumab and SBRT35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
The severity of dose-limiting toxicities (DLTs) will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This measure will help assess the clinical significance and impact of DLTs experienced by the participants.
- Frequency of Adverse Events (AEs) in patients treated with iadademstat combined with atezolizumab and SBRT35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
The number of participants experiencing adverse events (AEs) of any kind, regardless of causality, during the study period will be recorded. This outcome measure will provide insight into the overall safety profile of the combination treatment.
- Rate of Adverse Events (AEs) in patients treated with iadademstat combined with atezolizumab and SBRT35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
The proportion of participants experiencing adverse events (AEs), expressed as a percentage of the total participants, will be calculated. This measure aims to quantify the incidence rate of AEs in patients treated with iadademstat combined with atezolizumab and SBRT.
- Grade of Adverse Events (AEs) in patients treated with iadademstat combined with atezolizumab and SBRT35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
The severity of adverse events (AEs) will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. This measure will help assess the clinical significance and impact of AEs experienced by the participants.