TER-2013 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, TER-2013, to evaluate its safety and effectiveness for people with advanced solid tumors that have specific genetic changes. Researchers aim to understand how the drug works alone or with another medication, fulvestrant. The study is open to individuals with advanced cancers, such as breast, ovarian, or lung cancer, who have already tried up to three different treatments without success. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the TER-2013 trial?
The trial information does not specify if you need to stop taking your current medications. However, it does exclude participants who have taken certain inhibitors related to the AKT/PI3K/PTEN pathway. It's best to discuss your current medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has examined TER-2013 for its safety and side effects. Studies are testing TER-2013 alone or with fulvestrant (another cancer drug) to assess patient tolerance. These studies are in the early stages, so researchers are still learning about its safety in humans.
Fulvestrant, when combined with TER-2013, has been studied alone and with other drugs. It generally has a manageable safety profile, although side effects can occur. When used with other treatments, fulvestrant has demonstrated an acceptable safety profile.
As the current studies for TER-2013 are in the early phases, safety information is still being gathered. These studies are crucial for understanding patient tolerance and potential side effects. Prospective participants should discuss any concerns with the trial team.12345Why are researchers excited about this trial's treatments?
Researchers are excited about TER-2013 for cancer because it offers a unique approach compared to standard treatments like chemotherapy and hormone therapy. Unlike conventional therapies, TER-2013 is being tested both as a monotherapy and in combination with fulvestrant, a hormone therapy, which could enhance its effectiveness against certain cancers. The treatment is undergoing dose escalation and expansion trials to determine the optimal dosage, potentially maximizing its benefits while minimizing side effects. This dual approach could lead to a more personalized treatment option, providing hope for improved outcomes in cancer care.
What evidence suggests that TER-2013 might be an effective treatment for cancer?
Research has shown that TER-2013 targets specific changes in cancer cells, particularly in the AKT/PI3K/PTEN pathway. This pathway often alters in advanced solid tumors, making TER-2013 a promising treatment option. Early results suggest that TER-2013 can help shrink tumors.
In this trial, some participants will receive TER-2013 as a monotherapy, while others will receive it combined with fulvestrant. When used with fulvestrant, TER-2013 may enhance treatment effects. Fulvestrant alone has proven effective in treating hormone receptor-positive breast cancer, helping some patients delay disease progression. Together, TER-2013 and fulvestrant aim to better target cancer cells and improve patient outcomes.16789Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors like certain types of cancer in the breast, lung, ovaries, endometrium (lining of the uterus), esophagus, cervix, and head or neck. These tumors must have specific genetic changes in the AKT/PI3K/PTEN pathway.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Evaluation of safety, tolerability, and pharmacokinetics of TER-2013 as a monotherapy and in combination with fulvestrant to determine the maximum tolerated dose
Dose Expansion
Further evaluation of TER-2013 at the recommended dose in monotherapy and combination therapy settings
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TER-2013
Find a Clinic Near You
Who Is Running the Clinical Trial?
Terremoto Biosciences Inc.
Lead Sponsor