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

Conditions

• Fallopian Tube Neoplasms
• Neoplasm Metastasis
• Ovarian Neoplasms
• Peritoneal Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sofetabart Mipitecan — DRUG
  Administered IV
• Paclitaxel — DRUG
  Administered IV
• Topotecan — DRUG
  Administered IV
• Gemcitabine — DRUG
  Administered IV
• Pegylated liposomal doxorubicin (PLD) — DRUG
  Administered IV
• MIRV — DRUG
  Administered IV
• Bevacizumab — DRUG
  Administered IV
• Carboplatin — DRUG
  Administered IV

Study Details

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.

Key Dates

Start date

Oct 22, 2025

Status verified

May 2026

Primary completion

Apr 30, 2028

Completion

Aug 31, 2031

Study Design

Enrollment

1,080 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: Sofetabart Mipitecan
  Administered intravenously (IV).
• Active Comparator: Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)
  Investigator's Choice of Chemotherapy or MIRV given IV.
• Experimental: Part B: LY4170156 plus Bevacizumab
  Administered IV.
• Active Comparator: Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab
  Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Randomization to radiographic progression or death from any cause (up to 70 months) ]

Central Contacts

• Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (82)

Find similar trials in Birmingham, AL

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