Recruiting NCT07213804

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

Phase III Interventional Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms Neoplasm Metastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine.
Who it may be relevant to: Registry conditions: Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasm Metastasis. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Austria, Belgium, Brazil +21
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

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

Primary outcome measures

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator [Time frame: 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 Blinded, Independent, Central Review (BICR) [Time frame: Randomization to radiographic progression or death from any cause (up to 70 months)]

Secondary outcome measures (12)

Overall Survival (OS) [Time frame: Randomization to date of death from any cause (up to 70 months)]
PFS [Time frame: Randomization to radiographic progression or death from any cause (up to 70 months)]
Overall Response Rate (ORR): Proportion of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Time frame: Randomization to disease progression or death (up to 70 months)]
Duration of Response (DOR) [Time frame: Date of first documented CR or PR to date of radiographic progression or death from any cause (up to 70 months)]
Disease Control Rate (DCR): Proportion of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD) [Time frame: Randomization to disease progression or death from any cause (up to 70 months)]
PFS2 [Time frame: Randomization to disease progression on next line of treatment or death from any cause (up to 70 months)]
Time to Initiation of First Subsequent Systemic Anticancer Therapy or Death (TNTD) [Time frame: Randomization to initiation of subsequent systemic anticancer or death from any cause (up to 70 months)]
Proportion of Participants with Response of Cancer Antigen-125 (CA-125) per Gynecologic Cancer Intergroup Criteria (GCIG) [Time frame: Randomization to 30 days post treatment discontinuation]
Percentage of Assessments with High Side-effect Bother, as measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT GP5) [Time frame: Randomization to 30 days post treatment discontinuation]
Change from Baseline in Abdominal/GI Symptoms, as measured by the European Organization for Research and Treatment of Cancer Ovarian Cancer Module (EORTC OV28) [Time frame: Randomization to 30 days post treatment discontinuation]
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 [Time frame: Randomization to 30 days post treatment discontinuation]
Pharmacokinetics (PK): Minimum Blood Plasma Concentration (Cmin) of LY4170156 [Time frame: Randomization through end of treatment (up to 70 months)]]

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 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment