Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by Ritu Salani (ucla)

Description

Summary

This is a clinical study that has two parts. It is testing a potential new medicine called 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 LY4170156 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.

Official Title

FRAmework-01: A Two-Part Phase 3 Study of LY4170156 Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and LY4170156 Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.

Keywords

Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasm Metastasis, Folate Receptor Alpha, Antibody-drug Conjugate, Platinum-Resistant, Platinum-Sensitive, sofe-m, Paclitaxel, Topotecan, Gemcitabine, liposomal doxorubicin, Bevacizumab, Carboplatin, Pegylated liposomal doxorubicin, MIRV, LY4170156, LY4170156 plus Bevacizumab, Platinum-based Doublet Chemotherapy plus Bevacizumab

Eligibility

You can join if…

Open to people ages 18 years and up

Part A and B:

  • Have histologically confirmed high-grade serous 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.

You CAN'T join if...

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

Locations

  • UCLA Hematology/Oncology - Westwood (Building 100) not yet accepting patients
    Los Angeles California 90095 United States
  • Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center not yet accepting patients
    Burbank California 91505 United States
  • Stanford Women's Cancer Center not yet accepting patients
    Palo Alto California 94305 United States
  • Trials 365 accepting new patients
    Shreveport Louisiana 71103 United States

Lead Scientist at University of California Health

  • Ritu Salani (ucla)
    Professor, Obstetrics and Gynecology, Medicine. Authored (or co-authored) 162 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
Related Info
ID
NCT07213804
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1080 study participants
Last Updated