Iadademstat + SBRT With Atezo in ES-SCLC (NCT07113691) | Clinical Trial Compass
RecruitingPhase 1
Iadademstat + SBRT With Atezo in ES-SCLC
United States15 participantsStarted 2026-01-20
Plain-language summary
This is a phase 1b dose escalation, open-label, non-randomized study of participants with residual, progressive or recurrent ES-SCLC who previously received platinum-based chemotherapy with or without immune checkpoint inhibitor therapy; participants who have achieved only stable disease at the completion of initial platinum-based treatment are eligible for enrollment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed informed consent form.
✓. Ability to comply with protocol, in the treating investigator's judgment.
✓. Age 18 years or older.
✓. Participant must have a body weight of at least 50 Kg.
✓. Histologically documented ES-SCLC previously treated with at least one regimen, including a platinum containing chemotherapy regimen, with progression of disease on or after their most recent therapy or achieving only SD after completion of one line of a platinum containing chemotherapy-based regimen.
✓. Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, antiPD-1, and anti-PD-L1 therapeutic antibodies is allowed.
✓. ECOG performance status of 0 to 2.
✓. At least one identified tumor lesion to be treated with SBRT.
Exclusion criteria
✕. History of leptomeningeal disease.
✕. Untreated symptomatic CNS metastases. Participants with asymptomatic CNS metastases are eligible. Participant with treated symptomatic brain metastases is eligible provided they meet all of the following criteria:
✕. Completed stereotactic radiosurgery at least seven days prior to Cycle 1, Day 1 or completed whole brain radiation at least two weeks prior to Cycle 1, Day 1.
✕
What they're measuring
1
Frequency of Dose-Limiting Toxicities (DLTs) in patients treated with iadademstat combined with atezolizumab and SBRT
Timeframe: 35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
2
Rate of Dose-Limiting Toxicities (DLTs) in patients treated with iadademstat combined with atezolizumab and SBRT
Timeframe: 35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
3
Grade of Dose-Limiting Toxicities (DLTs) in patients treated with iadademstat combined with atezolizumab and SBRT
Timeframe: 35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
4
Frequency of Adverse Events (AEs) in patients treated with iadademstat combined with atezolizumab and SBRT
Timeframe: 35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
5
Rate of Adverse Events (AEs) in patients treated with iadademstat combined with atezolizumab and SBRT
Timeframe: 35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
6
Grade of Adverse Events (AEs) in patients treated with iadademstat combined with atezolizumab and SBRT
Timeframe: 35 days post the first dose of study drug on Cycle 1 Day 1, each cycle is 28 days long
. No evidence of interim progression between the completion of CNS-directed therapy and the start of trial therapy.
✕. Ongoing steroid requirement of \<10 mg of prednisone per day (or equivalent) as therapy for CNS disease; anticonvulsants are allowed.
✕. The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.
✕. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for more than or equal to 1 week prior to enrollment.