LY4170156 for Ovarian Cancer
(FRAmework-01 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new medicine, LY4170156, for treating specific ovarian, peritoneal, and fallopian tube cancers. It aims to determine if this treatment works better and is safer than current options. The trial consists of two parts: one for cancers that no longer respond to platinum-based chemotherapy and another for those that still do. People whose cancer has progressed after previous treatments and who have certain types of ovarian cancer might be suitable candidates. Participants will receive treatments through an IV, and their continued involvement will depend on their response to the treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that LY4170156 is well-tolerated by patients with advanced solid tumors. These studies have yielded promising results, with patients generally managing the treatment well, even those with extensive prior treatments.
When combined with Bevacizumab, the safety results for LY4170156 remain encouraging. Bevacizumab, already used to treat ovarian cancer, has been extensively studied. Patients have generally tolerated it well in real-world settings, though individual experiences may vary.
Overall, LY4170156, both alone and with Bevacizumab, has demonstrated a positive safety profile in research so far. However, individual responses can differ, so discussing any concerns with a doctor is important.12345Why are researchers excited about this study treatment for ovarian cancer?
Unlike the standard treatments for ovarian cancer, which often involve chemotherapy or targeted therapies like Mirvetuximab Soravtansine, LY4170156 is unique because it is an investigational drug with a potentially new mechanism of action. Researchers are particularly excited about LY4170156 due to its novel approach when combined with Bevacizumab, a well-known angiogenesis inhibitor, which might enhance its effectiveness against ovarian tumors. This combination could offer new hope for patients by potentially improving outcomes beyond what current standard therapies achieve.
What evidence suggests that LY4170156 could be an effective treatment for ovarian cancer?
Research has shown that LY4170156 may help treat ovarian cancer. Early studies found that LY4170156 could stop tumor growth in various lab models, even when other treatments, like mirvetuximab soravtansine, were ineffective. In this trial, some participants will receive LY4170156 alone, while others will receive it with Bevacizumab. A study with patients who had solid tumors, including ovarian cancer, showed that LY4170156 provided a clinical benefit to 56% of participants, meaning more than half experienced positive effects. Additionally, when combined with Bevacizumab, LY4170156 appeared to improve treatment results, although detailed results in humans remain limited. These findings suggest LY4170156 might be effective for certain types of ovarian cancer, especially when standard treatments fail.12678
Who Is on the Research Team?
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for individuals with certain ovarian, peritoneal, and fallopian tube cancers. Part A includes those whose cancer doesn't respond to platinum-based chemo anymore. Part B involves those still responding to such treatments. Participants must meet specific health criteria not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LY4170156 or chemotherapy/mirvetuximab soravtansine in Part A, and LY4170156 plus bevacizumab or platinum-based chemotherapy plus bevacizumab in Part B
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY4170156
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
GOG Foundation
Collaborator
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
Collaborator