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

NCT07213804
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,630
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Lead sponsor
Eli Lilly and Company
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Start date
2025-10-22
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Number of sites
268
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Summary
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.
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Acronym
FRAmework-01
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Short 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
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Official title
FRAmework-01: A Three-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.
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2031-08-01
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First posted
2025-10-09
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Registry last updated
2026-08-21
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Primary completion date
2028-11-01
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Start date
2025-10-22
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Participants
1,630
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Participant count basis
Estimated
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Planned participants
1,630
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Protocol amendments
3
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Number of sites
268
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07213804
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ClinicalTrials.gov ID
NCT07213804
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator

    Timeframe: Randomization to radiographic progression or death from any cause (up to 70 months)

    PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator

  2. PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded, Independent, Central Review (BICR)

    Timeframe: Randomization to radiographic progression or death from any cause (up to 70 months)

  1. Overall Survival (OS)

    Timeframe: Randomization to date of death from any cause (up to 70 months)

  2. PFS

    Timeframe: Randomization to radiographic progression or death from any cause (up to 70 months)

    PFS by blinded independent central review (BICR)

  3. Overall Response Rate (ORR): Proportion of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)

    Timeframe: Randomization to disease progression or death (up to 70 months)

    ORR per RECIST v1.1

  4. Duration of Response (DOR)

    Timeframe: Date of first documented CR or PR to date of radiographic progression or death from any cause (up to 70 months)

    DOR per RECIST v1.1

  5. Disease Control Rate (DCR): Proportion of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD)

    Timeframe: Randomization to disease progression or death from any cause (up to 70 months)

    DCR per RECIST v1.1

  6. PFS2

    Timeframe: Randomization to disease progression on next line of treatment or death from any cause (up to 70 months)

  7. Time to Initiation of First Subsequent Systemic Anticancer Therapy or Death (TNTD)

    Timeframe: Randomization to initiation of subsequent systemic anticancer or death from any cause (up to 70 months)

  8. Proportion of Participants with Response of Cancer Antigen-125 (CA-125) per Gynecologic Cancer Intergroup Criteria (GCIG)

    Timeframe: Randomization to 30 days post treatment discontinuation

    Per GCIG

  9. Percentage of Assessments with High Side-effect Bother, as measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT GP5)

    Timeframe: Randomization to 30 days post treatment discontinuation

    FACT-GP5 is a single-item, patient-reported instrument for assessing overall treatment side-effect burden. High side effect bother is defined as a score of 3 or 4 on a 5-point Likert scale. Higher scores represent higher symptom burden.

  10. Change from Baseline in Abdominal/GI Symptoms, as measured by the European Organization for Research and Treatment of Cancer Ovarian Cancer Module (EORTC OV28)

    Timeframe: Randomization to 30 days post treatment discontinuation

    The EORTC OV28 consists of 28 items covering 3 functional scales and 5 symptom scales. The Abdominal/GI symptom scale ranges from 0 to 100. Higher scores indicate worse symptoms.

  11. Change from Baseline in Overall Health-related Quality of Life (HRQoL), as measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale

    Timeframe: Randomization to 30 days post treatment discontinuation

    The EORTC QLQ-C30 is a 30-question patient-reported instrument used to assess multidimensional HRQoL in cancer patients. Overall HRQoL is measured by the EORTC QLQ-30 Global Health Status/Quality of Life Subscale (two items). Response options range from 0 - 100. Higher score represents better overall HRQoL.

  12. Pharmacokinetics (PK): Minimum Blood Plasma Concentration (Cmin) of LY4170156

    Timeframe: Randomization through end of treatment (up to 70 months)]

  13. PFS

    Timeframe: Randomization to radiographic progression or death from any cause (up to 70 months)

    PFS by investigator assessment per RECIST v1.1

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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.

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).

Sources for eligibility
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  • University of Alabama at BirminghamBirmingham, United StatesNot yet recruiting
  • HonorHealthPhoenix, United StatesRecruiting
  • Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical CenterBurbank, United StatesRecruiting
  • City of Hope, DuarteDuarte, United StatesNot yet recruiting
  • City of Hope LennarIrvine, United StatesNot yet recruiting
  • Kaiser Permanente Zion Medical CenterIrvine, United StatesRecruiting
  • Moores Cancer CenterLa Jolla, United StatesNot yet recruiting
  • UCLA Hematology/Oncology - Westwood (Building 100)Los Angeles, United StatesRecruiting
  • Stanford Women's Cancer CenterPalo Alto, United StatesRecruiting
  • Sansum ClinicSanta Barbara, United StatesRecruiting
  • Kaiser PermanenteVallejo, United StatesNot yet recruiting
  • Anschutz Cancer PavilionAurora, United StatesNot yet recruiting
  • AdventHealth Medical Group - PorterDenver, United StatesNot yet recruiting
  • UConn HealthFarmington, United StatesRecruiting
  • Broward Health Medical CenterFort Lauderdale, United StatesRecruiting
  • Florida Cancer Specialist- SouthFort Myers, United StatesRecruiting
  • Baptist MD Anderson Cancer CenterJacksonville, United StatesRecruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer CenterMiami, United StatesRecruiting
  • Mount Sinai Braman Comprehensive Cancer CenterMiami Beach, United StatesRecruiting
  • AdventHealth OrlandoOrlando, United StatesNot yet recruiting
  • Moffitt Cancer CenterTampa, United StatesNot yet recruiting
  • Florida Cancer Specialist- EastWest Palm Beach, United StatesRecruiting
  • Winship Cancer Institute, Emory UniversityAtlanta, United StatesRecruiting
  • Nancy N. & J.C. Lewis Cancer and Research PavillionSavannah, United StatesNot yet recruiting
  • Kapiolani Medical Center for Women and ChildrenHonolulu, United StatesNot yet recruiting

And 243 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-522255-25-00
  • J5E-MC-JZXB
  • GOG-3133
  • APGOT-OV17
  • ENGOT-ov97/GINECO-NOGGO-AGO-A
Sources for references
clinicaltrials.gov

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