TORL-1-23 with Chemotherapy for Advanced Ovarian Cancer
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
Recruiting
Phase 1Phase 2Interventional Study
FIGO Stage III and IV Ovarian CancerFallopian Tube CancersPrimary Peritoneal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Female
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
TORL Biotherapeutics, LLC · Industry
Who this trial is looking for
This trial is looking for women with advanced ovarian cancer who can take a new treatment called TORL-1-23 along with chemotherapy before their surgery. Participants will need to meet certain health requirements to join.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with epithelial ovarian cancer or a similar condition.
I have advanced stage cancer (Stage III or IV).
I have a specific marker called claudin 6.
I have good overall health.
You may not be able to join if
I have a different type of ovarian cancer, like clear cell or low-grade.
I have received treatment for ovarian cancer before.
I have had surgery for the cancer before.
I have had radiation treatment in my abdomen or pelvis before.
I have lung problems like pneumonitis in the last 6 months.
I have active brain metastases.
I have serious uncontrolled health issues.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
A Phase 1B/2 Study to Investigate the Safety and Efficacy of TORL-1-23 with Chemotherapy Given Before Initial Surgery in Women with Advanced Stage Ovarian Cancer
Trial Locations
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Eligibility Criteria
Inclusion 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 fun…
Inclusion 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
Exclusion Criteria:
* 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
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