A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
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. 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.
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 treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
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 of first line platinum-containing chemotherapy.
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. There is no waiting period required for stereotactic radiosurgery.
Parallel
TORL-1-23
Drug2.4mg/kg intravenous infusion on Day 1 of every 3-week cycle.
TORL-1-23
Drug3.0 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
TORL-1-23
Drug3.4 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
Pegfilgrastim (drug)
Drug6.0 mg subcutaneous injection on Day 4 of each cycle.
To assess the efficacy of TORL-1-23 as a monotherapy in women with advanced PROC expressing CLDN6
Objective Response Rate (ORR) per RECIST v1.1 by Blinded Independent Central Review (BICR)
Duration of Response (DOR)
To assess additional efficacy outcome measures of TORL-1-23 per RECIST v1.1 by Blinded Independent Central Review (BICR) and investigator assessment
Objective Response Rate (ORR)
To assess additional efficacy outcome measures of TORL-1-23 per RECIST v1.1 by investigator assessment
Progression-free Survival (PFS)
To assess additional efficacy outcome measures of TORL-1-23 per RECIST v1.1 by Blinded Independent Central Review (BICR) and by investigator assessment
Overall Survival (OS)
To assess additional efficacy outcome measures of TORL-1-23
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TORL Biotherapeutics, LLC
Lead sponsor
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
