Advanced Solid Tumors study: ETX-636 dose escalation
Official title Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06993844
What this study is testing
What is ETX-636?
ETX-636 is an investigational oral tablet being studied as a potential treatment for advanced solid tumors. It is designed to selectively inhibit and degrade mutant PI3Kα proteins, which are involved in tumor growth.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to evaluate safety and early signs of effectiveness of ETX-636 in people with advanced solid tumors.
- Who it's for
- Adults who have advanced solid tumors that cannot be cured with standard treatments.
- What's involved
- Participants will receive the investigational drug ETX-636 and undergo regular medical check‑ups and lab tests.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Newport Beach, California, United States
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
- Huntersville, North Carolina, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
- Beijing, China
- Fuzhou, China
- Guangzhou, China
- Shandong, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Newport Beach, California, United States; San Francisco, California, United States; New Haven, Connecticut, United States; Boston, Massachusetts, United States; Huntersville, North Carolina, United States; Houston, Texas, United States and 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.