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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,630 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for people with certain types of ovarian, fallopian tube, or peritoneal cancer. Participants will take a new treatment called Sofetabart Mipitecan to see if it works better than standard therapies.
Are You a Good Fit for This Trial?
You may be able to join if
I have high-grade serous or endometrioid ovarian cancer.
I have a good performance status (ECOG 0-1).
I have measureable disease.
I have had my cancer progress on or after my last treatment.
I have tumor tissue available for testing.
I have received 1 to 3 prior lines of chemotherapy (4 lines if one includes mirvetuximab soravtansine).
I have previously taken bevacizumab unless I cannot.
If I have a BRCA mutation, I have been treated with a PARPi if needed.
You may not be able to join if
I have had cancer progression within the past month after first-line platinum chemotherapy.
I have received a prior antibody-drug conjugate with a topoisomerase inhibitor.
I have clinically significant proteinuria.
I have a known pathogenic BRCA1/2 gene alteration.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 pla…
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.
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
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 anti…
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).
Contacts
Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or
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