Iadademstat + SBRT With Atezo in ES-SCLC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
History of leptomeningeal disease.
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.
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.
Trial design
Treatments tested in this trial
- Iadademstat
- Atezolizumab
- SBRT
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov