A Phase I/II, 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

Study Identifier:
ETX636-C-001
CT.gov Identifier:
NCT06993844
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-636 in participants with advanced solid tumors harboring a PIK3CA mutation. To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ETX-636 in participants with advanced solid tumors harboring a PI3Kα mutation

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Breast Cancers
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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. Tumor tissue or ctDNA testing confirms the presence of an activating PIK3CA gene mutation after disease progression following at least one existing treatment for locally advanced or metastatic disease.
  • The RECIST v1.1 criteria indicate the presence of at least one measurable or evaluable lesion.
  • An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 indicates a fitness status score of 0 or 1.
  • Organ function is good
Exclusion criteria
  • 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. Patient has a history of solid tumors or hematologic malignancies with histological types different from those in this study (within 2 years prior to the screening period).
  • The presence of symptomatic brain or spinal cord metastases, or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
  • Diagnosed with type 1 diabetes or uncontrolled type 2 diabetes
  • Those who have received any local or systemic anticancer treatment or experimental anticancer drug therapy within 14 days prior to the start of the study intervention.
  • The toxicity caused by previous anticancer treatment has not returned to baseline levels, except for hair loss and peripheral neuropathy.
  • The patient had received radiation therapy in areas outside the tumor target lesion within 14 days prior to the start of the study.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Amita Patnaik
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Solid Tumor