Breast Cancer study: TER-2013 vs Fulvestrant injection
Official title A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
ClinicalTrials.gov ID: NCT07109726
What this study is testing
What is TER-2013?
TER-2013 is an investigational medicine, taken by mouth, being studied as a potential treatment for breast cancer.
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 is looking at how safe and tolerable TER-2013 is, how the body processes it, and whether it shows any anti‑tumor activity.
- Who it's for
- Adults with advanced breast, endometrial, ovarian, lung, head‑and‑neck, esophageal, cervical or other solid tumors that carry AKT/PI3K/PTEN pathway alterations.
- What's involved
- Participants will receive TER-2013 and attend regular clinic visits for safety checks, blood tests, and imaging scans to monitor the tumor.
- Time commitment
- The trial runs for several months, with visits typically every few weeks for treatment and assessments.
- 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
- Key Metastatic or locally advanced, unresectable disease
- No available treatment with curative intent
- Presence of lesions to be evaluated per RECIST v1.1: a. Dose Escalation: measurable or evaluable disease b. Cohort Expansion: measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
You likely can't join if
- Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration
- Clinically significant abnormalities of glucose metabolism
- Active brain metastases or carcinomatous meningitis.
- History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug
- Malabsorption syndrome, nausea and vomiting uncontrolled by medication, or disease significantly affecting gastrointestinal function likely to...
- [For TER-2013 monotherapy escalation]: AKT inhibitor
See the full eligibility criteria
- Key Metastatic or locally advanced, unresectable disease
- No available treatment with curative intent
- Presence of lesions to be evaluated per RECIST v1.1: a. Dose Escalation: measurable or evaluable disease b. Cohort Expansion: measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Histologically confirmed diagnosis of: a. [For TER-2013 dose escalation]: solid tumor malignancy b. [For TER-2013 cohort expansion]: i.
- [For TER-2013 dose escalation]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused
- [For TER-2013 cohort expansion]: No more than 3 prior lines of treatment in the advanced setting Key for TER-2013 and fulvestrant combination arms
- Histologically confirmed diagnosis of: a. [For TER-2013 + fulvestrant dose escalation]: HR+/HER2- advanced unresectable or metastatic breast cancer b. [For TER-2013 + fulvestrant cohort expansion]: i.
- Prior Therapy: a. [For TER-2013 + fulvestrant dose escalation]: Received treatment with an AI containing regimen (single agent or in combination) b. [For TER-2013 + fulvestrant cohort expansion]: i.
- Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration
- Clinically significant abnormalities of glucose metabolism
- Active brain metastases or carcinomatous meningitis.
- History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug
- Malabsorption syndrome, nausea and vomiting uncontrolled by medication, or disease significantly affecting gastrointestinal function likely to interfere with the delivery, absorption, or metabolism of TER-2013
- [For TER-2013 monotherapy escalation]: AKT inhibitor
- [For TER-2013 monotherapy expansion]: AKT/PI3K/PTEN pathway inhibitor
- [For TER-2013 + fulvestrant combination expansion]: AKT/PI3K/PTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor.
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Irvine, California, United States
- Orlando, Florida, United States
- Zion, Illinois, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Milwaukee, Wisconsin, United States
- Lisbon, Portugal, Portugal
- San Juan, Puerto Rico
- Barcelona, Spain, Spain
- Madrid, Spain, Spain
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 Duarte, California, United States; Irvine, California, United States; Orlando, Florida, United States; Zion, Illinois, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States and 13 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.