Trial studying safety and effects for FIGO Stage III and IV Ovarian Cancer
Official title CATALINA-4: A Study to Investigate the Safety and Efficacy of TORL-1-23 With Chemotherapy Given Before Initial Surgery in Women With Advanced Stage Ovarian Cancer
ClinicalTrials.gov ID: NCT07322094
What this study is testing
What is TORL-1-23 and paclitaxel?
An investigational combination of TORL-1-23 and paclitaxel being studied as a potential treatment for advanced stage (FIGO Stage III and IV) ovarian cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if TORL‑1‑23 is safe and works when given with chemotherapy before the first surgery.
- Who it's for
- Women who have stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.
- What's involved
- Participants receive TORL‑1‑23 together with standard chemotherapy before surgery, plus routine lab tests and doctor visits to monitor safety.
- Time commitment
- Treatment is given before surgery, with follow‑up visits and tests for several weeks to months after the dose.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tubes cancer
- FIGO Stage III or IV
- Positive for claudin 6 (CLDN6) expression
- Adequate organ function
You likely can't join if
- Clear cell, mucinous, sarcomatous, mixed histology, low-grade/borderline, or non-epithelial ovarian cancers
- Prior systemic treatment for the disease under study
- Prior surgery
- Prior radiation therapy to the abdomen or pelvis
- Current recipient or receipt within 5-half-lives of C1D1 of any of the following: chemotherapy, biologic/targeted therapy, herbal medications or...
- History of noninfectious pneumonitis/interstitial lung disease (ILD) within 6 months of first dose of study drug.
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tubes cancer
- FIGO Stage III or IV
- Positive for claudin 6 (CLDN6) expression
- Adequate organ function
- Clear cell, mucinous, sarcomatous, mixed histology, low-grade/borderline, or non-epithelial ovarian cancers
- Prior systemic treatment for the disease under study
- Prior surgery
- Prior radiation therapy to the abdomen or pelvis
- Current recipient or receipt within 5-half-lives of C1D1 of any of the following: chemotherapy, biologic/targeted therapy, herbal medications or supplements, immunomodulator therapy for any disease indication.
- History of noninfectious pneumonitis/interstitial lung disease (ILD) within 6 months of first dose of study drug.
- Active, progressive, or symptomatic brain metastases
- Participants considered poor medical risks due to serious, uncontrolled medical conditions, active infections, or nonmalignant systemic diseases
- Pregnant or breastfeeding women
The study team makes the final eligibility decision.
Where it is enrolling
- Fullerton, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fullerton, California, United States; Irvine, California, United States; Los Angeles, California, United States; Rochester, Minnesota, United States; New York, New York, United States; Durham, North Carolina, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.