Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEnsem Therapeutics
About this trial
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
Eligibility criteria
Qualifiers
Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy.
Tumor harboring an activating PIK3CA mutation detected in either tumor tissue or ctDNA.
At least 1 measurable lesion or evaluable disease per RECIST v1.1.
An ECOG performance status score of 0 or 1.
Disqualifiers
Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.
Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2.
Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment.
Trial design
Treatments tested in this trial
- ETX-636 dose escalation
- ETX-636 dose escalation in combination with fulvestrant
- ETX-636 dose expansion in combination with fulvestrant
Treatment groups
233 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov