TORL123-002 / CATALINA-2 (Gynecologic Cancers)
What is the 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.
What is the Condition Being Studied?
Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Who Can Participate in the Study?
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
For more information, contact the study team at william.s.andrews@duke.edu.
Age Group
Adults
What is Involved?
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
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
Professor of Obstetrics and Gynecology
Protocol Number
IRB:
PRO00117280
NCT:
NCT06690775
Phase
Phase
II
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL
Participate
Call 919-684-3780