CATALINA-2: A targeted medicine called TORL-1-23 as treatment for people with advanced platinum-resistant epithelial ovarian, primary peritoneal and fallopian tube cancers that express the Claudin 6 protein (CLDN6)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

Inclusion

Participants are eligible to be included in the study only if all the following criteria apply:

1. 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.
2. 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.

3. Disease Type:

   • 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. High-grade endometrioid ovarian cancer is permitted for enrollment.
   • 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.
   • Participants must have platinum-resistant disease, defined as the following:
   • 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 last dose of platinum.
   • 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.
   • Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single- agent therapy is appropriate as the next line of treatment. Study rules for evaluation of number of prior systemic lines of therapy:
   • 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
4. Measurable disease, per RECIST v1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

6. Adequate organ function, based on the following laboratory values:

   • 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.
7. 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.
8. 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.
9. Participants must agree not to donate eggs from the first study drug treatment through 7 months after the last study drug treatment.
10. Participants must agree to not breastfeed from the first dose of study treatment through 90 days after the last dose of study treatment.