Purpose of this Study
People in this study may get up to 8 treatment cycles. Each cycle lasts 21 days. Usually, there are 3 to 4 cycles before surgery and 2 to 4 cycles after surgery, depending on how the cancer responds and what the doctor decides. The whole treatment takes about 8 months, and doctors will check on patients for up to 15 more months. This means the study lasts about 24 months in total.
Doctors will place patients into one of three groups (A, B, or C). This is not random. All groups will get a medicine called TORL 123.
Group A: TORL 123 plus paclitaxel
Group B: TORL 123 plus carboplatin
Group C: TORL 123 plus both paclitaxel and carboplatin
Medicine is given through an IV on Day 1 of each cycle. There will also be extra visits and blood tests during the cycle.
Who Can Participate?
Eligibility
To join this study, women must have newly diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The tumor must test positive for something called Claudin 6 (CLDN6). Doctors can use tissue from an earlier biopsy or may need to do a new one. Patients must have healthy blood counts and organs. Doctors will check blood often, and treatment may be paused if counts are too low.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is trying to find out if adding a new medicine called TORL 123 to regular chemotherapy can help people with newly diagnosed ovarian cancer do better than using chemotherapy alone.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Catalina-4: Phase 1b/2 Study of Torl-1-23 with Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Newly Diagnosed Patients with Advanced Stage Ovarian Cancer
Principal Investigator
Angeles
Secord
Protocol Number
PRO00119316
NCT ID
NCT07322094
Phase
I/II
Enrollment Status
Pending Open to Enrollment