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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on cancers that start in the ovary, the fallopian tube, or the lining of the abdomen, known as ovarian cancer, Fallopian Tube Neoplasms and Peritoneal Neoplasms. Some of these tumors spread to other parts of the body, a process called metastasis. In this research, two groups are defined: tumors that have grown back despite previous treatment with platinum‑based drugs (platinum-resistant) and tumors that respond again after a period without such treatment (platinum-sensitive).

The purpose of the study is to compare the effectiveness of a new medicine with that of standard chemotherapy. The investigational drug being tested is Sofetabart Mipitecan (LY4170156). For participants with platinum-resistant disease, the new drug may be given alone and compared with the doctor’s choice of chemotherapy drugs such as carboplatin, paclitaxel, gemcitabine, topotecan or doxorubicin, or with Mirvetuximab Soravtansine. For those with platinum-sensitive disease, the new drug is combined with bevacizumab and compared with a standard platinum‑based two‑drug chemotherapy regimen plus bevacizumab.

Participants receive the study medicines through an IV infusion every few weeks and attend regular clinic visits where doctors perform physical examinations and imaging scans to check how the cancer is responding. Treatment continues until the cancer grows, side effects become unacceptable, or the study period ends, which may be several months for each participant.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After joining the study you will have a series of baseline tests that may include blood work, imaging scans, and other examinations to document the current status of your disease.

    These assessments are performed before any study medication is given and provide the reference point for later comparisons.

  2. Step 2

    Treatment assignment

    Based on the part of the study you are enrolled in, you will be assigned to receive either sofetabart mipitecan alone (part a) or sofetabart mipitecan together with bevacizumab (part b).

    If you are placed in the control arm, the investigator will choose one of the standard chemotherapy options or mirvetuximab soravtansine.

  3. Step 3

    Study drug infusion

    The study medication sofetabart mipitecan (ly4170156) is given by intravenous infusion, which means it is delivered directly into a vein through a needle or catheter.

    The exact dose is defined by the study protocol and is calculated according to your body surface area or weight; the infusion is administered on the day assigned for each treatment cycle.

  4. Step 4

    Bevacizumab infusion (part b only)

    If you are in part b, you will also receive bevacizumab by intravenous infusion.

    The dose is 15 mg per kilogram of body weight (mg/kg) and is given on the same day as the study drug or as specified by the protocol.

  5. Step 5

    Control chemotherapy infusion (if assigned)

    If you are assigned to the control arm, you will receive one of the following chemotherapy agents by intravenous infusion:

    gemcitabine hydrochloride – 1000 mg per square meter of body surface area (mg/m2)

    carboplatin – 900 mg/m2

    topotecan – 4 mg/m2

    paclitaxel – 175 mg/m2

    doxorubicin hydrochloride – 40 mg/m2

    Or the targeted agent mirvetuximab soravtansine at a dose of 6 mg per kilogram (mg/kg).

    The chosen drug is administered as a single infusion on the designated treatment day for each cycle.

  6. Step 6

    Repeated treatment cycles

    The infusion(s) described in the previous steps are repeated for multiple cycles as defined by the study schedule.

    Each cycle typically includes a treatment day followed by a recovery period during which you will be monitored for side effects and disease status.

  7. Step 7

    Monitoring visits

    Between treatment cycles you will attend regular monitoring visits that may include physical examinations, blood tests, and imaging scans to assess how the disease is responding and to check for any adverse effects.

    These visits are essential for determining whether treatment should continue as planned.

  8. Step 8

    End‑of‑treatment assessment

    After the final planned cycle, a comprehensive assessment is performed to evaluate the overall outcome of the treatment.

    This assessment includes the same types of tests performed at baseline and may be used to determine progression‑free survival, the primary endpoint of the study.

Who can join the trial?

6 criteria

  • Have cancer of the ovary, fallopian tube, or peritoneum (the lining of the abdomen).
  • Show good organ function and normal blood counts on laboratory tests, meaning the kidneys, liver, and bone‑marrow are working properly.
  • Be able to walk and do light work such as gentle house chores, shopping, or short walks.
  • For the part of the study that treats platinum‑resistant disease (Part A), the cancer must have come back or gotten worse within 6 months after the last dose of platinum‑based chemotherapy (a strong cancer medicine that contains the metal platinum).
  • For the part of the study that treats platinum‑sensitive disease (Part B), the cancer must have come back or gotten worse 6 months or more after the last dose of platinum‑based chemotherapy.
  • Must be a female (woman) who meets the study’s age requirements.

Who cannot join the trial?

3 criteria

  • Cannot have previously taken an antibody‑drug conjugate (a special medicine that links an antibody to a cell‑killing drug) that contains a topoisomerase inhibitor (a drug that untangles DNA).
  • For the Part A group, cannot have cancer that returned or got worse within the first 3 months after the last dose of the initial platinum chemotherapy (a cancer treatment that uses platinum‑based medicines).
  • For the Part B group, cannot have too much protein in the urine, known as proteinuria (excess protein detected in a urine test).
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Investigated drugs

  • GEMCITABINE

    is a chemotherapy drug given through a vein. It works by stopping cancer cells from copying their DNA, which helps slow or shrink tumors. In this study it is one of the standard chemotherapy options that doctors may choose for patients in the control group.

  • CARBOPLATIN

    is another chemotherapy medicine administered intravenously. It damages the DNA inside cancer cells, making it harder for them to grow and spread. It is also part of the usual chemotherapy choices that can be used in the control arm of the trial.

  • TOPOTECAN

    is a chemotherapy agent given by IV. It interferes with an enzyme needed for DNA replication, helping to stop cancer cells from dividing. It may be selected by investigators as one of the chemotherapy options for patients in the control group.

  • PACLITAXEL

    is a chemotherapy drug delivered through a vein. It blocks the ability of cancer cells to form the structures they need to divide, which can slow tumor growth. It is another possible chemotherapy choice for the control arm.

  • DOXORUBICIN

    is an IV chemotherapy medication that works by inserting itself into DNA and preventing cancer cells from multiplying. It is also among the standard chemotherapy options that doctors might use for patients in the control group.

  • MIRVETUXIMAB SORAVTANSINE

    is a targeted therapy that combines an antibody with a cell‑killing drug. The antibody part seeks out a protein often found on ovarian cancer cells, delivering the toxin directly to those cells while sparing most normal cells. In the trial it can be chosen as the control treatment for patients with platinum‑resistant disease.

What is already known about the treatment

  • Gemcitabine

    Gemcitabine is given by slow intravenous injection and is an approved chemotherapy drug used for many solid tumors, including ovarian cancer. It works by mimicking a building block of DNA, which stops cancer cells from copying their genetic material and leads to their death. It belongs to the class of nucleoside analog chemotherapy agents. In medical literature it is widely studied and routinely used in cancer treatment protocols.

  • Carboplatin

    Carboplatin is administered through an intravenous infusion and is a standard chemotherapy drug for ovarian and other gynecologic cancers. It damages the DNA of cancer cells by forming cross‑links, which prevents the cells from dividing. It is classified as a platinum‑based chemotherapy agent. It has been approved for many years and is well documented in clinical studies.

  • Mirvetuximab soravtansine

    Mirvetuximab soravtansine is given by intravenous infusion and is an approved targeted therapy for certain ovarian cancers that have a specific folate receptor. It combines an antibody that finds the cancer cell with a toxin that kills the cell once attached. This makes it an antibody‑drug conjugate. It is a newer drug with growing evidence from recent trials.

  • Topotecan

    Topotecan is delivered by intravenous injection and is an approved chemotherapy for ovarian and other cancers that have returned after treatment. It blocks an enzyme needed for DNA replication, causing cancer cells to break apart. It belongs to the class of topoisomerase inhibitors. It has been used for decades and is well described in the medical literature.

  • Sofetabart Mipitecan (LY4170156)

    Sofetabart Mipitecan is given as an intravenous infusion of a lyophilized powder that is reconstituted before use and is currently an experimental drug being tested in phase 3 trials for ovarian cancer. It works by interfering with the DNA copying process in a way similar to other chemotherapy agents, but with a design meant to reduce side effects. It is classified as a novel DNA‑targeting agent under investigation. Because it is still in trials, it is not yet approved for general medical use.

  • Bevacizumab

    Bevacizumab is administered by intravenous infusion and is an approved biologic used together with chemotherapy for ovarian and other cancers. It blocks a protein called VEGF that tumors need to grow new blood vessels, effectively starving the tumor. It is classified as an anti‑angiogenic monoclonal antibody. It has been on the market for many years and is well supported by clinical research.

Investigated diseases

  • Fallopian Tube Neoplasms

    These are abnormal growths that develop in the lining of the fallopian tubes. They may start as small growths and gradually enlarge, sometimes causing blockage of the tube. As they grow, they can extend into nearby pelvic organs or spread through the lining of the abdomen.

  • Peritoneal Neoplasms

    These are tumors that arise on the surface that lines the abdominal cavity. They often begin as localized patches and can expand across the peritoneal surface. Over time they may involve surrounding organs and spread within the abdominal space.

  • Ovarian Neoplasms

    These are abnormal tissue growths that originate in the ovaries. They typically start inside the ovary and can increase in size, potentially distorting the organ. With progression, they may extend to the pelvic region, the abdomen, or travel through lymph channels.

  • Neoplasm Metastasis

    This term describes the process by which cancer cells move from an original tumor to form new growths in other parts of the body. Cells break away, travel through blood or lymph vessels, and settle in distant tissues. The new tumors then grow in their new location, following a similar pattern of expansion.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522255-25-00Protocol codeJ5E-MC-JZXBEstimated enrolment1 125 patientsSponsorEli Lilly & Co.

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