Cancer Clinical Trials
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Learn MoreWhat is the purpose of this study?
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
Eligibility
Key Inclusion Criteria:
- 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.
- Adequate organ function.
Additional key inclusion criterion for Parts B and C:
- Confirmed metastatic or locally advanced HR+/HER2- breast cancer not amenable to surgical resection with curative intent and must have received at least 1 prior CDK4/6 inhibitor and at least 1 prior anti-estrogen therapy.
- 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.
- Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy.
- Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors
- Disease Type/ConditionAdvanced Solid Tumors, Advanced Breast Cancer
- Principal InvestigatorMonica Mita, MD
- Co-InvestigatorsAlain Mita, MD , Carlos R. Becerra, MD, Chelsea Brown, NP, Yaser Homsi, MD, Simon Khagi, MD
- Age GroupAdult, Older Adult
- PhaseII
- ClinicalTrials.gov IDNCT06993844
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Lauren Wagner
lauren.wagner@hoag.org
Hoag Family Cancer Institute
Hoag Family Cancer Institute delivers advanced, compassionate cancer care across Orange County, with multidisciplinary specialists, precision therapies, support services, and access to 125+ cancer clinical trials. Patients benefit from research-driven care across a wide range of cancers, including breast, lung, gynecologic, prostate, gastrointestinal, and blood cancers.
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