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A Two-Part Phase 3 Study of S...

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1080 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-22

Study Completion Date

2031-08-31

Brief Summary

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This is a clinical study that has two parts. It is testing a potential new medicine called Sofetabart Mipitecan (LY4170156) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based treatments (a type of chemotherapy). Part B looks at participants whose cancer still responds to platinum-based treatments. The researchers want to find out if Sofetabart Mipitecan works better than the usual treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.

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Detailed Description

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Conditions

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Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms Neoplasm Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: Sofetabart Mipitecan

Administered intravenously (IV).

Group Type EXPERIMENTAL

Sofetabart Mipitecan

Intervention Type DRUG

Administered IV

Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)

Investigator's Choice of Chemotherapy or MIRV given IV.

Group Type ACTIVE_COMPARATOR

MIRV

Intervention Type DRUG

Administered IV

Paclitaxel

Intervention Type DRUG

Administered IV

Topotecan

Intervention Type DRUG

Administered IV

Gemcitabine

Intervention Type DRUG

Administered IV

Pegylated liposomal doxorubicin (PLD)

Intervention Type DRUG

Administered IV

Part B: LY4170156 plus Bevacizumab

Administered IV.

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Administered IV

Sofetabart Mipitecan

Intervention Type DRUG

Administered IV

Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab

Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

Administered IV

Carboplatin

Intervention Type DRUG

Administered IV

Paclitaxel

Intervention Type DRUG

Administered IV

Gemcitabine

Intervention Type DRUG

Administered IV

Pegylated liposomal doxorubicin (PLD)

Intervention Type DRUG

Administered IV

Interventions

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MIRV

Administered IV

Intervention Type DRUG

Bevacizumab

Administered IV

Intervention Type DRUG

Carboplatin

Administered IV

Intervention Type DRUG

Sofetabart Mipitecan

Administered IV

Intervention Type DRUG

Paclitaxel

Administered IV

Intervention Type DRUG

Topotecan

Administered IV

Intervention Type DRUG

Gemcitabine

Administered IV

Intervention Type DRUG

Pegylated liposomal doxorubicin (PLD)

Administered IV

Intervention Type DRUG

Other Intervention Names

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LY4170156

Eligibility Criteria

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Inclusion Criteria

Part A and B:

* Have histologically confirmed high-grade serous or high-grade 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 greater than or equal to (≥)1 but ≤3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior 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:

* 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 but ≤2 prior lines of systemic cytotoxic chemotherapy
* Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.

Exclusion Criteria

Part A and B:

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

Part A:

\- Have primary platinum-refractory disease, defined as disease that progressed ≤3 months since the last dose of first-line platinum-containing chemotherapy.

Part B:

\- Have clinically significant proteinuria

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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