FIGO Stage III and IV Ovarian CancerPhase 1/2NCT07322094
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
A Phase 1/2 study testing TORL-1-23 and paclitaxel, TORL-1-23 and carboplatin and TORL-1-23, paclitaxel, and carboplatin in people with FIGO Stage III and IV Ovarian Cancer and Fallopian Tube Cancers, run by TORL Biotherapeutics, LLC at 7 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- FIGO Stage III and IV Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer
- What is being tested?
- TORL-1-23 and paclitaxel, TORL-1-23 and carboplatin and TORL-1-23, paclitaxel, and carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 Dec 2025to Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27705
- Recruiting
Providence St. Jude Medical Center
Fullerton, California, 92835
- Recruiting
City of Hope
Irvine, California, 92618
- Recruiting
University of Southern California
Los Angeles, California, 90007
- Recruiting
UCLA
Los Angeles, California, 90095
Principal Investigator, 310-348-9636
- Recruiting
Mt Sinai Hospital
New York, New York, 10029
- Recruiting
The Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official 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
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
- Being tested
- TORL-1-23 and paclitaxel, TORL-1-23 and carboplatin, TORL-1-23, paclitaxel, and carboplatin
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TORL-1-23 and paclitaxelCombination product
TORL-1-23 and paclitaxel
TORL-1-23 and carboplatinCombination product
TORL-1-23 and carboplatin
TORL-1-23, paclitaxel, and carboplatinCombination product
TORL-1-23, paclitaxel, and carboplatin
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A: TORL-1-23 and paclitaxel | Experimental | Administered once every three weeks Receives: Combination Product: TORL-1-23 and paclitaxel |
| Treatment Arm B: TORL-1-23 and carboplatin | Experimental | Administered once every three weeks Receives: Combination Product: TORL-1-23 and carboplatin |
| Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin | Experimental | Administered once every three weeks Receives: Combination Product: TORL-1-23, paclitaxel, and carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the safety and feasibility of TORL-1-23 in combination with chemotherapy by analyzing the incidence of treatment emergent adverse events and serious adverse events.
Incidence of Grade greater than or equal to 3 (using CTCAE V5.0) treatment-emergent adverse event (TEAE) and related serious adverse event (SAE)
Measured: Treatment during Cycle 1 to Cycle 4 (Each cycle is 21 days)
To assess the efficacy of neoadjuvant TORL-1-23 in combination with chemotherapy
Determination of percentage CRS3 score for each treatment arm
Measured: postoperative after Cycle 4 (Each cycle is 21 days)
Secondary outcomes (2)
To assess the tolerability of TORL-1-23 in combination with chemotherapy
Safety assessed by incidence of intolerable Grade 2 and Grade greater than or equal to 3 TEAE and related SAE.
Measured: Treatment up to Cycle 8 (each cycle is 21 days)
To characterize duration of benefit for TORL-1-23 plus chemotherapy
Relapse free survival for participants
Measured: Measured up to 15 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start10 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FIGO Stage III and IV Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TORL Biotherapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322094
- Sponsor's protocol ID
- TORL123-004
- Status last verified
- Jul 2026
- First submitted
- 17 Dec 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07322094
- Acronym / sponsor ID
- TORL123-004
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TORL Biotherapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A: TORL-1-23 and paclitaxel | Experimental | Combination Product: TORL-1-23 and paclitaxelAdministered once every three weeks |
| Treatment Arm B: TORL-1-23 and carboplatin | Experimental | Combination Product: TORL-1-23 and carboplatinAdministered once every three weeks |
| Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin | Experimental | Combination Product: TORL-1-23, paclitaxel, and carboplatinAdministered once every three weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TORL-1-23 and paclitaxelTORL-1-23 and paclitaxel | Combination product | Treatment Arm A: TORL-1-23 and paclitaxel |
| TORL-1-23 and carboplatinTORL-1-23 and carboplatin | Combination product | Treatment Arm B: TORL-1-23 and carboplatin |
| TORL-1-23, paclitaxel, and carboplatinTORL-1-23, paclitaxel, and carboplatin | Combination product | Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin |
Primary outcome
Characterize the safety and feasibility of TORL-1-23 in combination with chemotherapy by analyzing the incidence of treatment emergent adverse events and serious adverse events.
Time frame: Treatment during Cycle 1 to Cycle 4 (Each cycle is 21 days)
Incidence of Grade greater than or equal to 3 (using CTCAE V5.0) treatment-emergent adverse event (TEAE) and related serious adverse event (SAE)
To assess the efficacy of neoadjuvant TORL-1-23 in combination with chemotherapy
Time frame: postoperative after Cycle 4 (Each cycle is 21 days)
Determination of percentage CRS3 score for each treatment arm
2 secondary outcomes
To assess the tolerability of TORL-1-23 in combination with chemotherapy
Time frame: Treatment up to Cycle 8 (each cycle is 21 days)
To characterize duration of benefit for TORL-1-23 plus chemotherapy
Time frame: Measured up to 15 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TORL-1-23 and paclitaxel, TORL-1-23 and carboplatin and TORL-1-23, paclitaxel, and carboplatin in people with FIGO Stage III and IV Ovarian Cancer and Fallopian Tube Cancers, run by TORL Biotherapeutics, LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Labib, PharmD (310-348-9636, caroline.labib@torlbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the safety and feasibility of TORL-1-23 in combination with chemotherapy by analyzing the incidence of treatment emergent adverse events and serious adverse events. (time frame: Treatment during Cycle 1 to Cycle 4 (Each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.