NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms Neoplasm Metastasis
Date of first enrollment	09/02/2026
Target sample size	1080
Countries of recruitment	United States,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Ireland,Japan,Italy,Japan,Mexico,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Romania,Japan,South Korea,Japan,Spain,Japan,Switzerland,Japan,United Kingdom,Japan
Study type	Interventional
Intervention(s)	DRUG: Sofetabart Mipitecan(Other Name: LY4170156) Administered IV DRUG: Paclitaxel Administered IV DRUG: Topotecan Administered IV DRUG: Gemcitabine Administered IV DRUG: Pegylated liposomal doxorubicin (PLD) Administered IV DRUG: MIRV Administered IV DRUG: Bevacizumab Administered IV DRUG: Carboplatin Administered IV (Study Arms) Experimental: Part A: Sofetabart Mipitecan Administered intravenously (IV). Interventions: Drug: Sofetabart Mipitecan Active Comparator: Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV) Investigator's Choice of Chemotherapy or MIRV given IV. Interventions: Drug: Paclitaxel Drug: Topotecan Drug: Gemcitabine Drug: Pegylated liposomal doxorubicin (PLD) Drug: MIRV Experimental: Part B: LY4170156 plus Bevacizumab Administered IV. Interventions: Drug: Sofetabart Mipitecan Drug: Bevacizumab Active Comparator: Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV. Interventions: Drug: Paclitaxel Drug: Gemcitabine Drug: Pegylated liposomal doxorubicin (PLD) Drug: Bevacizumab Drug: Carboplatin

Outcome(s)

Primary Outcome	Progression-free Survival (PFS) [Time Frame: Randomization to radiographic progression or death from any cause (up to 70 months)] PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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