A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
Purpose
This is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard 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.
Conditions
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Neoplasm Metastasis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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).
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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: Sofetabart Mipitecan 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. |
|
|
Experimental Part C: Sofetabart Mipitecan plus Bevacizumab |
Administered IV |
|
|
Active Comparator Part C: Platinum-based Doublet Chemotherapy plus Bevacizumab |
Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV. |
|
Recruiting Locations
Phoenix, Arizona 85016
Burbank, California 91505
818-748-4726
Irvine, California 92618
714-393-6482
Los Angeles, California 90095
310-794-3639
Palo Alto, California 94305
Santa Barbara, California 93105
Fort Myers, Florida 33901
Jacksonville, Florida 32207
904-202-7300
West Palm Beach, Florida 33401
Arlington Heights, Illinois 60005
847-259-4482
Peoria, Illinois 61637
Indianapolis, Indiana 46237
Lexington, Kentucky 40503
859-278-5671
Louisville, Kentucky 40207
Shreveport, Louisiana 71103
Scarborough, Maine 04074
Baltimore, Maryland 21204
Baltimore, Maryland 21215
410-601-9083
Detroit, Michigan 48201
Kalamazoo, Michigan 49007
269-382-2500
Columbia, Missouri 65212
573-882-7440
Reno, Nevada 89511
775-327-4673
Mineola, New York 11501
212-731-6455
New York, New York 10016
212-731-6455
New York, New York 10065
646-888-4227
Centerville, Ohio 45459
937-438-7819
Cincinnati, Ohio 45242
513-751-2273 x22401
Columbus, Ohio 43219
Hilliard, Ohio 43026
Eugene, Oregon 97401
Portland, Oregon 97213
Portland, Oregon 97227
503-249-3315
Portland, Oregon 97239
503-494-7999
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19107
215-481-6069
Willow Grove, Pennsylvania 19090
215-481-6069
Austin, Texas 78731
The Woodlands, Texas 77380
Webster, Texas 77598-4420
281-332-7505
Salt Lake City, Utah 84112
801-213-5750
Madison, Wisconsin 53792
More Details
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
Study Contact
Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
LillyTrials@Lilly.com