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

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What is this study about?

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.

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 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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
General Hospital Of Messinia Kalamata Greece
Technische Universitaet Dresden Dresden Germany
Oslo Universitetssykehus HF Oslo Norway
Katholieke Universiteit te Leuven Leuven Belgium
Hopitaux Universitaires Paris Centre-Hopital Cochin Paris France
Medical University Of Vienna Vienna Austria
Medical University Of Graz Graz Austria
Medizinische Universitaet Innsbruck Innsbruck Austria
Hospital Universitario Hm Sanchinarro Madrid Spain
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Ospedale Vito Fazzi Lecce Lecce Italy
Institut Jules Bordet Anderlecht Belgium
Universitaetsklinikum Erlangen AöR Erlangen Germany
Alexandra Hospital Athens Greece
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Azienda USL Toscana Centro Prato Italy
University Hospital Olomouc Olomouc Czechia
Rigshospitalet Copenhagen Denmark
General Oncological Hospital Of Kifissia Agioi Anargyroi Kifissia Greece
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Helse Stavanger HF Stavanger Norway
Az Maria Middelares Gent Gent Belgium
Krajska Nemocnice T Bati a.s. Zlin Czechia
Fakultni Nemocnice Brno Brno Czechia
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Orszagos Onkologiai Intezet Budapest Hungary
University Of Debrecen Debrecen Hungary
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie Poznan Poland
Mnt Healthcare Europe S.R.L. Pantelimon Romania
Institutul Regional De Oncologie Iasi Iasi Romania
Universidade De Santiago De Compostela Santiago De Compostela Spain
Oncocenter Oncologie Clinica S.R.L. Timisoara Romania
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Consorcio Hospitalario Provincial De Castellon Castello De La Plana Spain
Hospital Universitario Infanta Sofía San Sebastian De Los Reyes Spain
CHRU de Brest Brest France
Centre Hospitalier De La Cote Basque Bayonne France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Charité Campus Virchow-Klinikum Berlin Germany
Hospital Universitario Virgen De La Victoria Malaga Spain
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Mazowiecki Szpital Wojewodzki w Siedlcach Sp. z o.o. Siedlce Poland
Awftpgc Oamippoijwt Pqp Lbfnhnbaprypkcqyc Cetqmlxeie Catania Italy
Abpsggf Hwomfvqv Athens Greece
Ucromoiokaln Mswqeba Copukxb Ghekwthca Groningen The Netherlands
Ilhvmzye Ruopvqev Dr Cgkobq Dq Muwaelujvke Montpellier France
Cjqttq Hosjslnfpfr Et Uwsnkzhddsuow Dj Lyfmznk Limoges France
Apjkrri Uthub Sdlnzvvuk Ldzcsg Dc Brhyrfk Bologna Italy
Uvnhszkyzk Ox Axujnpc Edegem Belgium
Kvothuam Ectoeimoilhyymlwcpezlhpm Hhqmsvhuntbcuwexk Essen Germany
Allljor Uja Taitugu nvqk omaqc Leghorn Italy
Ugnqxueexc Hxpurmal Cvqneml Cologne Germany
Esmimuk Ulxszuzeaqtd Mvqjnce Cunkfwt Rvnqcqtxc (azpahre Mbi Rotterdam The Netherlands
Cldkbf Lxpe Bmizdf Lyon France
Utcsbwvmkxljgo Ceahoez Kkbrswqda Gdansk Poland
Sg Vxrbwarryrlsybj Umrbeloige Hqxrlyxa Dublin Ireland
Ciba Upwuclnzxy Hultkxke Cork Ireland
Ukbvlbtdkdaizhgpmjijw Dmfbuzhtnfk Axb Duesseldorf Germany
Cnqybv Oaolm Lattjuq Lille France
Hobwgemz Uvkqdihhqykjbd Sjslxrmlmj &ugquej Hyfkykm dd Hwtatwxqnch STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.03.2026
Belgium Belgium
Not yet recruiting
01.03.2026
Czechia Czechia
Not yet recruiting
01.03.2026
Denmark Denmark
Not yet recruiting
01.03.2026
France France
Recruiting
01.03.2026
Germany Germany
Not yet recruiting
01.03.2026
Greece Greece
Not yet recruiting
01.03.2026
Hungary Hungary
Not yet recruiting
01.03.2026
Ireland Ireland
Not yet recruiting
01.03.2026
Italy Italy
Not yet recruiting
01.03.2026
Norway Norway
Not yet recruiting
01.03.2026
Poland Poland
Recruiting
01.03.2026
Romania Romania
Recruiting
01.03.2026
Spain Spain
Recruiting
01.03.2026
The Netherlands The Netherlands
Not yet recruiting
01.03.2026

Trial locations

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.

BEVACIZUMAB is a medication that blocks a protein called VEGF, which tumors use to grow new blood vessels. By stopping new blood vessels from forming, it can help slow tumor growth. In this study it is given together with either the experimental drug or standard chemotherapy to see if it improves outcomes.

LY4170156 (also called Sofetabart Mipitecan) is an experimental drug being tested in this trial. It belongs to a class of medicines that interfere with an enzyme needed for DNA replication, aiming to stop cancer cells from dividing. In Part A it is compared alone against standard chemotherapy or mirvetuximab soravtansine, and in Part B it is given together with bevacizumab to see if the combination works better than standard chemotherapy plus bevacizumab.

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 ID:
2025-522255-25-00
Protocol code:
J5E-MC-JZXB
NCT ID:
NCT07213804
Trial Phase:
Therapeutic confirmatory (Phase III)

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