Epithelial Ovarian Cancer study: TORL-1-23 vs Pegfilgrastim
Official title CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
ClinicalTrials.gov ID: NCT06690775
What this study is testing
What is TORL-1-23?
an investigational intravenous medicine being studied as a potential treatment for advanced epithelial 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
- This study is testing whether the drug TORL-1-23 works well. It also checks how safe the drug is and what side effects it causes.
- Who it's for
- You may be able to join if you have advanced ovarian cancer that did not respond to platinum drugs.
- What's involved
- You would take the drug TORL-1-23. You would also have regular check-ups and tests to see how you are doing.
- Time commitment
- The study lasts for a set time, and you will need to visit the clinic for check-ups.
- 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 and older, women only
You may be able to join if
- Females ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the informed...
- Participants must sign the informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form...
- Histologically or cytologically confirmed diagnosis of advanced (unresectable) or metastatic high grade serous ovarian, primary peritoneal (i.e, of...
- Participant's tumor must be positive for CLDN6 expression as defined by the CLDN6 reference laboratory assay.
- If participants received only 1 line of platinum-based therapy, they must have completed 4 or more cycles of platinum-containing therapy, must have...
You likely can't join if
- Has not recovered [recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, Grade...
- Participants with clear cell, mucinous, sarcomatous (including carcinosarcoma), mixed histology, or low-grade, borderline ovarian tumors or...
- Participants with primary platinum-refractory ovarian, primary peritoneal (i.e.
- Received prior chemotherapeutic, investigational, radiotherapy, or other therapies for the treatment of cancer within 14 days with small molecule and...
- Prior treatment with a CLDN6-targeting agent or an MMAE-containing ADC.
- Progressive or symptomatic brain metastases. Brain metastases that have been radiated, are asymptomatic, and on a stable or decreasing dose of...
See the full eligibility criteria
Who can join
- Females ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the informed consent.
- Participants must sign the informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Histologically or cytologically confirmed diagnosis of advanced (unresectable) or metastatic high grade serous ovarian, primary peritoneal (i.e, of primary origin), or fallopian tube cancer.
- Participant's tumor must be positive for CLDN6 expression as defined by the CLDN6 reference laboratory assay. Tumor tissue will be required for submission for CLDN6 testing prior to Cycle 1 Day 1.
- If participants received only 1 line of platinum-based therapy, they must have completed 4 or more cycles of platinum-containing therapy, must have achieved a CR or PR, and progressed \>3 months but ≤6 months after the...
- Participants who have received more than 1 line of platinum- based therapy must have progressed on or within 6 months after the last dose of platinum.
- NOTE: This should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression (per RECIST v1.1).
- Participants who are platinum-refractory during front-line treatment are excluded.
- Adjuvant ± neoadjuvant is considered one line of therapy
- Maintenance therapy (eg, bevacizumab or PARP inhibitors) will be considered part of the preceding line of therapy (ie, not counted independently)
- Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)
- Hormonal therapy will not be counted as a separate line of therapy
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- ANC: ≥1,500/mcL
- Platelets: ≥100,000/mcL without transfusion within 4 weeks of first dose
- Hemoglobin: 9 g/dL with transfusion or EPO support up to 14 days before eligibility assessment
- Measured or calculated creatinine clearance with a validated formula\ : ≥30 mL/min
- Serum total bilirubin: ≤1.5 X ULN (participants with known Gilbert disease or liver metastases who have serum bilirubin level ≤3×ULN may be enrolled
- AST (SGOT) and ALT (SGPT): ≤3 X ULN (participants with active liver metastases who have ALT/AST ≤5 X ULN may be enrolled)
- Albumin: ≥2.5 g/dL
- ECG: 12-Lead ECG with normal tracing or non-clinically significant changes that do not require medical intervention and QTcF interval
- 470 msec and without history of Torsades des Pointes or other symptomatic QTc abnormality.
- Participants of childbearing potential must have a negative serum pregnancy test within 72 hours before starting study drug treatment. The serum pregnancy test must be negative for the participant to be eligible.
- Participants must agree to use a highly effective birth control method from the time of the first study drug treatment through 7 months after the last study drug treatment, or be of nonchildbearing potential.
- Participants must agree not to donate eggs from the first study drug treatment through 7 months after the last study drug treatment.
- Participants must agree to not breastfeed from the first dose of study treatment through 90 days after the last dose of study treatment.
What rules you out
- Has not recovered [recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, Grade ≤1] from the acute toxicities of previous therapy, except...
- Participants with clear cell, mucinous, sarcomatous (including carcinosarcoma), mixed histology, or low-grade, borderline ovarian tumors or non-epithelial ovarian cancers.
- Participants with primary platinum-refractory ovarian, primary peritoneal (i.e. of primary origin) or fallopian tube cancer, defined as disease that did not respond to or has progressed within 3 months of the last dose...
- Received prior chemotherapeutic, investigational, radiotherapy, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-1-23.
- Prior treatment with a CLDN6-targeting agent or an MMAE-containing ADC.
- Progressive or symptomatic brain metastases. Brain metastases that have been radiated, are asymptomatic, and on a stable or decreasing dose of steroids are allowed. Leptomeningeal disease is excluded.
- Grade 2 or greater peripheral neuropathy.
- History of non-infectious pneumonitis/ILD within 6 months of first dose of study drug.
- Participants must not be considered a high medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection.
- Congestive heart failure \>New York Heart Association class 2 within last year
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
- Myocardial infarction less than 6 months before start of study drug
- Anti-arrhythmic therapy (beta blockers are permitted)
- Any unstable ischemic disease or untreated arrhythmia
- Known history of myelodysplastic syndrome or acute myeloid leukemia.
- History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated.
- Uncontrolled infection; active, clinically serious infections (CTCAE Grade \>2).
- Participants with seizure disorder requiring medication.
- Known hypersensitivity or intolerance to any of the study drugs, study drug classes, or excipients in the formulation.
- History of having an allogeneic bone marrow or organ transplant.
- Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the...
- Participants who are taking any drugs that are strong inducers and/or strong inhibitors of CYP3A4 enzymes.
- Participants who are taking any drugs that are inhibitors of P-glycoprotein.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Duarte, California, United States
- Fullerton, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Santa Barbara, California, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Annapolis, Maryland, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New Brunswick, New Jersey, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
+ 38 more site(s).
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Tucson, Arizona, United States; Duarte, California, United States; Fullerton, California, United States; Los Angeles, California, United States; Palo Alto, California, United States and 52 more locations. 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.