Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

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.

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer (NCT07213804) is a Phase 3 interventional studying Ovarian Neoplasms and Fallopian Tube Neoplasms, sponsored by Eli Lilly and Company. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Ovarian Neoplasms, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 1,080 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

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.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07213804), the sponsor (Eli Lilly and Company), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07213804 clinical trial studying?

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 st… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07213804?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07213804?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07213804. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07213804. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.