Purpose of this Study
We are doing this study to find out if an experimental drug called TORL-1-23 (the study drug) is a safe and effective option for women who have advanced ovarian cancer, primary peritoneal, or fallopian tube cancer.
Who Can Participate?
Eligibility
Who ages 18+ who:
- Are diagnosed with one of the following types of cancer: high grade serous or endometrioid ovarian, primary peritoneal (of primary origin), or fallopian tube cancer
- Have disease that is advanced (cannot be removed surgically) or metastatic (has spread)
- Have a tumor that is positive for CLDN6 expression
- Have received at least 1 but not more than 3 previous lines of therapy
- Are resistant to platinum-based chemotherapy
Age Range
18-110
Sex/Genders
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (by chance) to 1 of 3 different groups. Depending on your assignment, you will either:
- Arm 1: If you are in this group, you will get a lower dose (2.4 mg/kg) of the study drug + another drug called pegfilgrastim (a medication that helps your body produce a type of white blood cell); OR
- Arm 2: If you are in this group, you will get a medium dose (3.0 mg/kg) of the study drug + pegfilgrastim; OR
- Arm 3: If you are in this group, you will get a higher dose (3.4 mg/kg) of the study drug + pegfilgrastim
Locations
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
CATALINA-2: A Phase 2 Study Evaluating the Efficacy and Safety of TORL-1-23 in
Women With Advanced Platinum-Resistant Epithelial Ovarian Cancer (Including
Primary Peritoneal and Fallopian Tube Cancers) Expressing Claudin 6
Women With Advanced Platinum-Resistant Epithelial Ovarian Cancer (Including
Primary Peritoneal and Fallopian Tube Cancers) Expressing Claudin 6
Principal Investigator
Angeles
Secord
Protocol Number
PRO00117280
NCT ID
NCT06690775
Phase
II
Enrollment Status
Open to Enrollment