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LY4170156

Clinical trials are investigating LY4170156, also called Sofetabart Mipitecan, in people with ovarian cancer and related cancers. This article explains what the trials are studying, who may join, and how the studies measure benefit and safety. The main goal is to compare LY4170156-based treatment with standard treatment options in different ovarian cancer groups.

Table of Contents

Trial overview

The main trial in the data is NCT07213804, a Phase 3 interventional study of LY4170156, also called Sofetabart Mipitecan, in ovarian cancer and related cancers.[1]

The study is designed in two parts: Part A for platinum-resistant ovarian cancer and Part B for platinum-sensitive ovarian cancer.[1]

Who is being studied

The trial includes people with ovarian neoplasms, fallopian tube neoplasms, peritoneal neoplasms, and neoplasm metastasis.[1]

These names mean the cancer starts in the ovary, fallopian tube, or peritoneum, and in some cases has spread to another part of the body.[1]

Part A focuses on people whose cancer is platinum-resistant, which means the cancer did not respond well to platinum treatment or returned soon after it.[1]

Part B focuses on people whose cancer is platinum-sensitive, which means the cancer still responds to platinum-based treatment.[1]

Treatments being compared

In Part A, the study compares Sofetabart Mipitecan (LY4170156) with the control arm, which is the investigator’s choice of chemotherapy or mirvetuximab soravtansine (MIRV).[1]

In Part B, the study compares Sofetabart Mipitecan plus bevacizumab with the control arm of investigator’s choice platinum-based doublet chemotherapy plus bevacizumab.[1]

These control arms show what standard treatment options the study is using for comparison, so researchers can see whether the LY4170156-based approach works better.[1]

Study endpoints

The main outcome in Part A is progression-free survival (PFS) measured by RECIST v1.1 and assessed by the investigator.[1]

The main outcome in Part B is progression-free survival measured by RECIST v1.1 and reviewed by blinded, independent, central review (BICR).[1]

Progression-free survival means the time during and after treatment when the cancer does not get worse.[1]

RECIST v1.1 is a standard method for measuring whether tumors grow, shrink, or stay the same.[1]

BICR means independent experts review the results without knowing which treatment a person received, which helps make the comparison fair.[1]

Trial status and size

The study status is Authorised, which means it has been approved to move forward.[1]

The planned enrollment is 1,125 participants, showing that this is a large study.[1]

The trial is interventional, meaning the researchers assign treatments and then measure the results.[1]

Trial ID Phase Condition studied Status Enrollment
NCT07213804 Phase 3 Ovarian cancer, fallopian tube neoplasms, peritoneal neoplasms, neoplasm metastasis Authorised 1125

FAQ

  • What is being studied in the LY4170156 trials? The trials are studying LY4170156, also called Sofetabart Mipitecan, in ovarian cancer and related cancers. The studies compare it with standard treatment choices to see which approach works better.
  • Who may take part in these trials? The trial is for people with ovarian cancer, including fallopian tube and peritoneal cancers. It includes two groups: people with platinum-resistant disease and people with platinum-sensitive disease.
  • What phase are the LY4170156 trials? This is a Phase 3 study. Phase 3 trials usually compare a new treatment with the current standard treatment in a larger group of people.
  • What are the main trial goals? The main goal is to compare how long patients live without the cancer getting worse. This is called progression-free survival, which means the time before the disease grows or spreads.
  • What treatments are compared with LY4170156? In one part of the study, LY4170156 is compared with the investigator’s choice of chemotherapy or mirvetuximab soravtansine. In another part, LY4170156 plus bevacizumab is compared with platinum-based doublet chemotherapy plus bevacizumab.

Ongoing Clinical Trials on LY4170156

  • Phase 3 Study of LY4170156 (Sofetabart Mipitecan) with drug combination in platinum‑resistant and platinum‑sensitive ovarian cancer patients

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +9

Glossary

  • Phase 3: A later-stage clinical trial that compares a study treatment with standard treatment in a larger group of people.
  • Interventional study: A study where researchers give a treatment and observe what happens.
  • Platinum-resistant: Cancer that does not respond well to platinum chemotherapy or returns soon after it.
  • Platinum-sensitive: Cancer that still responds to platinum chemotherapy, often after a longer time without the disease getting worse.
  • Ovarian cancer: Cancer that starts in the ovaries, the organs that make eggs and hormones.
  • Fallopian tube neoplasms: Tumors that start in the fallopian tubes, which connect the ovaries to the uterus.
  • Peritoneal neoplasms: Tumors that start in the peritoneum, the lining inside the abdomen.
  • Neoplasm metastasis: Cancer that has spread from where it started to another part of the body.
  • Progression-free survival (PFS): The length of time during and after treatment that the cancer does not get worse.
  • RECIST v1.1: A standard way doctors measure whether a tumor has grown, shrunk, or stayed the same.
  • Blinded, independent, central review (BICR): A review of scans or test results by experts who do not know which treatment the patient got, to help keep the results fair.
  • Bevacizumab: A treatment used in one part of the study as part of the comparison group or combined treatment group.

References