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
Trial Overview
The study tests LY4170156 against usual treatments like Paclitaxel and Bevacizumab in two groups: one resistant (Part A) and one sensitive (Part B) to platinum-based chemotherapy. It aims to determine if LY4170156 is more effective or safer.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Administered IV.
Administered intravenously (IV).
Investigator's Choice of Chemotherapy or MIRV given IV.
Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.
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
Citations
Initial results from a first-in-human phase 1 study of ...
Results: As of 27 Nov 2024, 45 pts were treated with LY4170156. Median age was 63 yrs (range, 24-85), 100% had ECOG PS 0-1, and 32 (71%) had ...
1067P Results from the first-in-human phase I study ...
LY4170156 demonstrated preclinical in vivo efficacy across all FRα expression levels and mirvetuximab soravtansine-gynx (mirv) resistant ovarian models, as well ...
ESMO 2025 preview – Astra joins the folate fray | ApexOnco
At ASCO this year, Lilly reported phase 1 data in solid tumours, with a focus on platinum resistant ovarian cancer, where LY4170156 reached a 56 ...
NCT06400472 | A Study of LY4170156 in Participants With ...
The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors.
Patient outcomes in advanced ovarian cancer treated with ...
Overall, median PFS was 3.5 months (95 % CI, 3.0–4.1). However, 22.4 % had PFS ≥6 months and were less likely to have progressed on or within one month of prior ...
795TiP A first-in-human phase I study of LY4170156, an ...
LOXO-FRA-24001 is a multicenter, open-label, first-in-human phase 1a/b study of LY4170156 in pts with advanced solid tumors expressing FRα.
Lilly presents first clinical data for its investigational, next- ...
LY4170156 demonstrated an encouraging safety profile and anti-tumor activity across dose and FRα expression levels in women with heavily pre-treated platinum- ...
FRα Antibody-Drug Conjugate Molecule Overview - HCP
In preclinical models, LY4170156 has shown activity against a range of FRα-expressing tumors, including low and moderate FRα-expressing ovarian tumors as well ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.