FRAmework-01: A Two-Part Phase 3 Study of LY4170156 versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer and LY4170156 plus Bevacizumab versus Platinum-Based Chemotherapy plus Bevacizumab in Platinum-Sensitive Ovarian Cancer

Brief description of study

This is a Phase 3 study testing a new medicine called LY4170156 (an investigational antibody-drug conjugate) targeting FRa for patients with advanced ovarian cancer whose cancer is either platinum-resistant or platinum-sensitive. In this study, ovarian cancer includes high-grade serous ovarian cancer, primary peritoneal cancer and fallopian tube cancer. LY4170156 is a new kind of treatment that delivers cancer medicine directly to cancer cells. This type of treatment may help people who have fewer treatment options, including those with different levels of FRa in their tumors.

The study has two separate parts, each for a different group of patients. Part A will include patients with platinum-resistant ovarian cancer (PROC) whose cancer came back or got worse within 6 months after their last platinum chemotherapy. Part B will include patients with platinum-sensitive ovarian cancer (PSOC) whose cancer responded to platinum treatment before and got worse during or within 6 months after treatment with a PARP inhibitor. In part A, patients will be randomly placed into one of two groups: one group will receive LY4170156 and the other group will receive a standard treatment, chosen by the study doctor before the study starts. The standard treatments include:paclitaxel, pegylated liposomal doxorubicin, gemcitabine, topotecan or MIRV (only for patients who have not had MIRV before and whose tumors test positive for FRa, where the drug is approved and available). In part B, patients will receive either LY4170156 with bevacizumab or a standard platinum-based chemotherapy plus bevacizumab, chosen by the study doctor before the study starts: carboplatin + paclitaxel, carboplatin + gemcitabine or carboplatin + pegylated liposomal doxorubicin. Each part of this study will focus on how well and how safely LY4170156 works for the different patient groups.

All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicine. The study team will have special scans done for all patients to see how the cancer is responding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.


Clinical Study Identifier: s25-00875
ClinicalTrials.gov Identifier: NCT07213804
Principal Investigator: Bhavana Pothuri.
Other Investigators: Anam Qureshi, Kent Chan, Cindy Corbo, Olivia Richardson Khouri, Sarah Saerohm Lee, Marina Stasenko, Jonathan B Kahn, Fabia Brisard Pierrot, Alexander A Hindenburg, Leslie R Boyd, Christina Grace Wilson, Michelle Diane Swanson Lightfoot, Emeline Mariam Aviki, Carol M Lee, Whitfield B. Growdon, Marilyn Huang, Anastasiya Apanasyuk, Victoria Helen Dowd, Rupal Bhana, Edward A Jimenez, Erin Annette Reese, Gabrielle Fridman, Kelly A Levine, Kathleen M Lutz.


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