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RECRUITINGPhase 3INTERVENTIONAL

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

FRAmework-01: A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: Part A and B: - Have diagnosed by tissue sample (biopsy-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 tumors that can be measured on scans 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. Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Sofetabart Mipitecan

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

Locations (20)

University of Alabama at Birmingham
Birmingham, Alabama, United States
HonorHealth
Phoenix, Arizona, United States
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center
Burbank, California, United States
City of Hope, Duarte
Duarte, California, United States
Moores Cancer Center
La Jolla, California, United States
UCLA Hematology/Oncology - Westwood (Building 100)
Los Angeles, California, United States
Stanford Women's Cancer Center
Palo Alto, California, United States
Kaiser Permanente Zion Medical Center
San Diego, California, United States
Sansum Clinic
Santa Barbara, California, United States
Kaiser Permanente
Vallejo, California, United States
Anschutz Cancer Pavilion
Aurora, Colorado, United States
AdventHealth Medical Group - Porter
Denver, Colorado, United States
UConn Health
Farmington, Connecticut, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Florida Cancer Specialist- South
Fort Myers, Florida, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States