Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Iadademstat · 1 trial · 1 indication
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Iadademstat + Atezolizumab | EXPERIMENTAL | The first three participants will start iadademstat at a dose of 600ug PO weekly (DL 1). Dose escalation and de-escalation will be guided by the BOIN design. Dose finding will continue until the pre-specified sample size of 15 is reached or stop the trial if the number of participants treated at the current dose reaches 12 and the decision is to stay at the current dose. Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1680mg on Day 1 of each 28-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the treating investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status (e.g., symptomatic deterioration such as pain secondary to disease). |
| Name | Type | Description |
|---|---|---|
| Iadademstat | DRUG | Iadademstat is administered orally (PO) on an empty stomach (two hours after eating or one hour prior to food ingestion). After drinking the entire solution, the participant will be asked to refill the bottle with water and drink it again. Then they will drink another glass of water to wash their mouth and esophagus. Time of administration of the drug should be the same every day, preferentially in the mornings, and the time should be registered using the Dosing Instructions and Participant Drug Diary. If a dose is missed, the dose should be administered as soon as possible within 24 hours of the missed dose time. If more than 24 hours have passed, or a dose is vomited, the participant should call their medical team for instructions. |
| Atezolizumab | DRUG | Atezolizumab will be administered by IV infusion at a fixed dose of 1680mg on Day 1 (+/-3 days) of each 28-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the treating investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Administration of atezolizumab will be performed in a monitored setting where there is immediate access to trained personnel and adequate equipment and medicine to manage potentially serious reactions. |
| SBRT | RADIATION | The first fraction of SBRT should be delivered after the initiation of iadademstat and atezolizumab, ideally between Cycle 1, Day 8, and Cycle 1, Day 15. Initiation of SBRT may be delayed up to 14 days beyond Cycle 1, Day 15 if iadademstat dose adjustment is required for toxicity |
Inclusion Criteria: 1. Signed informed consent form. 2. Ability to comply with protocol, in the treating investigator's judgment. 3. Age 18 years or older. 4. Participant must have a body weight of at least 50 Kg. 5. Histologically documented ES-SCLC previously treated with at least one regimen, in...