Sofetabart Mipitecan (LY4170156) versus standard chemotherapy for platinum-resistant and platinum-sensitive high-grade ovarian, fallopian tube, and primary peritoneal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This two-part Phase 3 trial separates participants into platinum-resistant (Part A) and platinum-sensitive (Part B) cohorts and compares Sofetabart Mipitecan to commonly used chemotherapies including paclitaxel, topotecan, gemcitabine, and pegylated liposomal doxorubicin. Eligible participants must have high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer with measurable disease, an ECOG performance status of 0-1, and available tumor tissue. The study tracks tumor response, progression-free and overall survival, and detailed safety and tolerability measures, with each participant's time on treatment determined by response. The trial is sponsored by Eli Lilly in collaboration with academic cooperative groups and is being conducted at multiple cancer centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Part A, B, and C:

* Have histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
* Have confirmed availability of tumor tissue block or slides
* Have radiographic progression on or after most recent line of systemic anticancer therapy
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Have measurable disease per RECIST v1.1

Part A:

* Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.
* Have previously received 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior cytotoxic therapy is allowed if one of those lines is mirvetuximab soravtansine.
* Have received prior bevacizumab treatment, unless documented contraindication or intolerance.
* Have received treatment with a poly (ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance.

Part B and C:

* Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (\>)6 months of their last administration of platinum therapy
* Have previously received 1 to 2 prior lines of systemic cytotoxic chemotherapy

Part B:

\- Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.

Part C:

\- Have not previously received a PARPi treatment.

Exclusion Criteria:

Parts A, B and C:

\- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.

Part A:

* Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy.

Part B and C:

\- Have clinically significant proteinuria

Part C:

\- Have a known pathogenic BRCA1/2 gene alteration (somatic or germline).

Where it's running

• HonorHealth
  Phoenix, Arizona, United States Recruiting
• Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center
  Burbank, California, United States Recruiting
• City of Hope, Duarte
  Duarte, California, United States Recruiting
• City of Hope Lennar
  Irvine, California, United States Recruiting
• Kaiser Permanente Zion Medical Center
  Irvine, California, United States Recruiting
• UCLA Hematology/Oncology - Westwood (Building 100)
  Los Angeles, California, United States Recruiting

+214 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Raludotatug Deruxtecan With or Without Bevacizumab as First‑Line Maintenance in Advanced Ovarian Cancer

  This trial tests whether maintenance therapy with raludotatug deruxtecan, with or without bevacizumab, helps people with advanced ovarian, fallopian tube, or primary peritoneal cancer live longer without the cancer growing after initial treatment.

  Recruiting at 13 sites Phase 3 Merck Sharp & Dohme LLC · Washington D.C., District of Columbia and 12 other locations · NCT07776691

• Mo-Rez maintenance therapy in first-line ovarian cancer

  This study tests mocertatug rezetecan (Mo-Rez) alone or with bevacizumab to see if it helps people with newly diagnosed advanced ovarian cancer, compared with bevacizumab alone or no active treatment after initial chemotherapy.

  Recruiting at 12 sites Phase 3 GlaxoSmithKline · Buenos Aires and 11 other locations · NCT07694427

• Mocertatug Rezetecan with Bevacizumab vs Platinum Doublet with Bevacizumab in Platinum-Sensitive Ovarian Cancer

  This trial tests whether mocertatug rezetecan plus bevacizumab helps people with platinum-sensitive ovarian cancer respond better than standard platinum-based therapy plus bevacizumab.

  Recruiting at 9 sites Phase 3 GlaxoSmithKline · Newcastle, New South Wales and 8 other locations · NCT07684612

• Sac-TMT maintenance for people with non-HRD advanced ovarian cancer

  This trial sees if sacituzumab tirumotecan (sac‑TMT), given with or without bevacizumab, can keep cancer from getting worse after surgery and first‑line platinum chemotherapy in people with non‑HRD advanced ovarian cancer.

  Recruiting at 177 sites Phase 3 Merck Sharp & Dohme LLC · Birmingham, Alabama and 176 other locations · NCT07318558

• Using a uterine wash and a blood protein test to find ovarian cancer early

  This project will try to find tumor DNA in a uterine wash plus protein markers in blood to detect ovarian or fallopian tube cancer in women having surgery for a suspected ovarian growth or BRCA1/2 carriers having risk-reducing surgery.

  Recruiting at 5 sites Massachusetts General Hospital · Little Rock, Arkansas and 5 other locations · NCT04794322

• Using letrozole as maintenance therapy for ovarian cancer

  This study is testing if adding letrozole to standard treatment helps women with estrogen-receptor positive ovarian cancer live longer without their cancer getting worse after surgery and chemotherapy.

  Recruiting at 51 sites Phase 3 Swiss GO Trial Group · Graz and 52 other locations · NCT04111978

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.