Clinical trial for Ovarian Neoplasms
Official title 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
ClinicalTrials.gov ID: NCT07213804
What this study is testing
What is Sofetabart Mipitecan?
This is an investigational medicine being studied as a potential treatment for certain types of ovarian, peritoneal, and fallopian tube cancers.
Also referred to as LY4170156, Sofe-M.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if the new medicine works better than current standard treatments and to learn more about its safety.
- Who it's for
- People with ovarian, fallopian tube, or peritoneal cancer that has either returned quickly after treatment or stayed controlled for at least six months.
- What's involved
- Participants will receive the new medicine and undergo regular medical tests and check-ups to monitor their health and how the cancer is responding.
- Time commitment
- The length of participation depends on how well the treatment works for each person.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.
You likely can't join if
- Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing...
See the full eligibility criteria
- 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 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 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...
- Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Burbank, California, United States
- Duarte, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Santa Barbara, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Farmington, Connecticut, United States
- Fort Lauderdale, Florida, United States
- Fort Myers, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Savannah, Georgia, United States
- Arlington Heights, Illinois, United States
+ 164 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Burbank, California, United States; Duarte, California, United States; Irvine, California, United States; Los Angeles, California, United States; Palo Alto, California, United States and 178 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.